QA Compliance Resume Sample
Work Experience
- Serve as the Site’s Safety and Environmental Leader
- Support external audit activities (FDA, FDB, ISO registrar audits etc.)
- Audit areas of Vascular Quality System
- Support administration of Quality System processes (CAPAs, Internal Audits etc.)
- Generate and distribute periodic open CAPA and Internal Audit Corrective Action (IACA) reports
- Assist the organization to receive timely feedback on open corrective actions
- Participate in cross divisional activities to integrate quality system information
- Conduct review and update Quality System procedures as necessary
- Assist in developing & conducting Quality System training as necessary
- Provide periodic review of Supply Chain Department documentation and records such as logbooks, receiving reports and Dispensing MR’s to assess for compliance with established quality standards, policies and procedures
- Serve as a Subject Matter Expert (SME) in Computer System Validation requirements for systems used by Shire’s global R&D Organization
- Conduct periodic audits and plant walk-throughs to ensure compliance to FDA’S QSR regulations
- Ensure compliance oversight for the implementation, management, and monitoring of operational activities supporting Amgen’s Risk Evaluation and Mitigation Strategy (REMS) programs
- Develop and Implement Quality Systems/Programs necessary to assure compliance with Good Laboratory Practices (GLP) and OECD GLP (as applicable)
- Serve as a representative during regulatory inspections, including over-seeing preparation of the facility for such inspections and hosting the inspection team
- Interface with FDA, Health Authorities and other appropriate agencies during regulatory inspections
- File Quality Records (audit reports, IACAs, CAPAs etc.)
- Ensure that all responsibilities are carried out in compliance with governing regulations and standards
- Review laboratory worksheets and electronic records
- Review, sign, and send final reports to clients
- Interact with clients regarding final report status and report amendments
- Perform job specific tasks in compliance with applicable Regulations, International Standards, and our Policies and Standard Operating Procedures
- Solution oriented, flexible and a reliable team player
- Previous exposure to banking or financial services
- Provide tracking and trending for all supply chain and materials management compliance activities i.e NOEs, EOE’s, CAPA’s
Education
Professional Skills
- Strong analytical skills, with problem solving skills and research capabilities
- Strong verbal and written communication skills, project management skills
- Demonstrated excellent leadership, organization and communication skills
- Strong written and communication skills including group presentations and training
- Excellent interpersonal skills including use of tact, diplomacy, discretion and judgment
- Demonstrate people skills, conflict resolution and communication
- Positive and proactive attitude: demonstrate teamwork, organizational skills, attention to details and follow-up
How to write QA Compliance Resume
QA Compliance role is responsible for training, interpersonal, compliance, research, database, leadership, reporting, integration, auditing, security.
To write great resume for qa compliance job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For QA Compliance Resume
The section contact information is important in your qa compliance resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your QA Compliance Resume
The section work experience is an essential part of your qa compliance resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous qa compliance responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular qa compliance position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative QA Compliance resume experience can include:
- Strong negotiation and interpersonal skills, team player
- Good interpersonal skills are required, as is the ability to communicate well, both verbally and written
- Lead, manage, support, and motivate the Quality Compliance Group, including identifying training needs and skills development
- Good knowledge of Computer System Validation
- Experience in a cGxP-regulated environment, with exhibited knowledge and proficiency of system validation and quality activities
- Demonstrated ability to meet deadlines, multitask, and change priorities while maintaining productivity
Education on a QA Compliance Resume
Make sure to make education a priority on your qa compliance resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your qa compliance experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in QA Compliance Resume
When listing skills on your qa compliance resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical qa compliance skills:
- Excellent organizational skills with attention to details, advanced computer skills
- Well organized, efficient worker with good communication skills
- GMP experience in the pharmaceutical industry with at least 7 years direct QA experience and at least 3-5 years of management experience
- Excellent communication skills and the ability to build relationships at all levels and across functions
- Good communication skills in matrix and line management environments
- Strong written, system organization, and communication skills
List of Typical Experience For a QA Compliance Resume
Experience For QA Compliance Specialist Resume
- Actively participate in effective deployment of the CAPA System (proposing, initiation, implementation, closure)
- Oversees the development, implementation and maintenance of quality assurance systems and activities in conformance with Good Manufacturing Practices (GMP)
- Ensure Quality Assurance oversight and involvement in Computer Validation Projects
- Authoring SOPs and/or Work Instruction relating to the escalation process and local recall process
- Contributing and providing report for APQRs for Complaints, BPDR, Recall and FARs
- Managing Compliance/ Audit programs and conducting audits in the medical device or drug industry
- Update and maintain required QA audit programs (internal/external), GLP training
Experience For QA & Compliance Supervisor Resume
- Supports functional teams to perform CAPA investigations, including use of industry recognized root cause analysis tools
- Manage, monitor and coordinate records in TrackWise System relating to escalation and complaints modules
- Provide QA oversight for on-floor surveillance of development GMP batch processing as needed and for other applicable quality related events
- Perform regular facility monitoring; efficiently follow up on observations and comments
- Perform Internal Audits (if assigned) including preparation, execution of the audit plan and create Internal Audit reports and agreement on appropriate CAPAs
- Gown up and enter the manufacturing plant
- Maintain relevant SOP’s, support for GMP training
- Maintain product quality by enforcing quality assurance polices and processes and government requirements
- Enforce vendor compliance policies, processing vendor charge backs as needed
Experience For Research QA & Compliance Lead Resume
- B.S. in Science / Engineering or the Physical or Biological Sciences
- Develop and/or review all responses to regulatory agency and corrective actions commitments
- Assume responsibility for Master schedule and SOP development and updates
- Work with the Development areas representative to resolve and mitigate vendor performance issues. Perform lesson’s learned as part of the continuous process improvement activities
- Experience and or cumulative experience in the areas of Project Management, Clinical Operations, Procurement, and Quality Assurance in a pharmaceuticals or biotechnology industry
- Experience writing and reviewing SOPs or tools which support Development activities
- Work independently with tight timelines and competing priorities
- Good understanding of FDA GCP and ICH regulatory requirements, Pharmacovigilance and GLP regulations and implementations
- Performs activities to assess the effectiveness of controls
Experience For QA Compliance Manager Resume
- Flexible without compromising quality
- Travel up to 30% (domestic and international), sometimes on short notice
- Manages and participates in audits including but not limited to SSAE 16, ISO 9001, contractual, financial, and business relationship audits conducted by the client
- Oversees onboarding / offboarding process from a compliance perspective. Works with global Atos Recruiting, Human Resources, and Hiring Managers to ensure that background check and drug screening requirements for in-scope countries are completed and in compliance
- Maintains an inspection readiness program for the assigned location ensuring personnel are prepared for their roles in Customer or regulatory agency audits
- Coordinates and/or participates in audits as required
- Reviews Atos-developed documents used to support the Customer for compliance with quality and regulatory requirements
- Works with all levels within the organization including the Managing Director, CBUs, Operational and Learning & Development teams, as well as with key leaders in the client’s organization
Experience For Senior Manager, IT QA & Compliance Resume
- Work with front-end and online content developers to guide feature and functionality development to be compliant with distribution platform and internal standards
- Update information and database
- Support the department’s vision, propose plan(s) and manage project deliverables to prepare the organization to support the growing Computer System Validation needs of the business, including enhancement and optimization of Computer System Validation program
- Build and maintain a strong robust Quality culture
- Implementation, Management and Development of QA activities including GMP documentation, training and associated systems;ISOtrain Training Systems; Auditing programs; Exeception Systems and Change Control Activities
- Ensure the site meets all appropriate Quality Standards
- Manage and deliver all QA activities related to New Product Introduction to the site
- Support review of manufactured batches as required
- BS in Microbiology (ideally) or related discipline
Experience For QA Compliance Auditor Resume
- Maintains comprehensive knowledge of applicable regulatory requirements and their interpretation. Provides regulatory compliance expertise to the site management by sharing external regulatory environment, industry trends as well recommending actions to address any potential impact to the site
- Provides leadership to the BDI site in the areas of Regulatory compliance and the Audit program. In addition, provides guidance to the local audit team members for the implementation of regulatory and quality system effectiveness audits of BDI sites and suppliers
- Coordinates and conducts routine and directed audits as needed to assure compliance with domestic and international regulations, local SOP’s and corporate standards. [i.e. QMS, QSIT, Combination Products, Regulatory requirements; Notified bodies , etc]
- Provides training, guidance and coaching to the compliance team auditors (if applicable), team SMEs in the conduct of audits, documentation of findings, support for auditee development of audit action plans and evaluation of effectiveness checks
- Provides auditor training to audit team members, internal auditors through formal classroom, web-based or on the job training
Experience For Oxo-QA Compliance Manager Resume
- Coordinate yearly/quarterly/monthly quality training as required
- Manages the site Internal Audit programs
- Ensure adequate GAP Analyses are performed for new/revised Corporate and Division documents. Implement changes as appropriate
- Supports the oversight of Smiths Medical compliance programs to ensure that activities occurs in a timely manner, including administration of the systems, training others within the organization on techniques used with the systems and coaching and providing adequate assistance to internal customers of the system
- Is also responsible for ensuring the organization is operating in compliance with Quality Policies, Standard Operating Procedures, GMP and other applicable regulations
- Supports the department manager in preparing and presenting data for internal and external audits
- Completes quality assessment of CAPA records to ensure compliance with procedures as required
Experience For QA-compliance / Jaws Resume
- Participates in the identification and implementation of process improvements in the Global CAPA system
- Works with the Global CAPA Manager to assist in the strategic oversight of CAPA programs at each Smiths Medical site, ensuring Global CAPA program health by providing metrics and reporting to Smiths Medical leaders and identifying and implementing process improvements in the Global CAPA system
- Reviews corrective action plans for internal and external audit responses, ensuring the responses satisfy company and regulatory requirements
- Support monthly reporting of metrics associated with the Quality Management System
- Accountable for completing activities within required timelines
- Works with the Global Compliance Manager to identify and implement process improvements in the Global Field Action program
Experience For APL QA Compliance Specialist Resume
- Assists with execution and reconciliation of field corrective actions and recalls
- Works with teams to develop field corrective action and recall plans
- Performs audits and assessments against company and regulatory requirements
- Researches and prepares correspondence in response to external government agencies
- Facilitate the review and approval of deviation reports; ensures appropriate corrective actions are assigned
- Writes environmental monitoring and water excursion reports; ensures appropriate corrective actions are assigned, provides periodic reports to management on status
- Assists with periodic internal audits of production and laboratory areas
Experience For Senior Manager of QA & Compliance Resume
- Assists with periodic audits of production and laboratory areas
- Performs batch record review for compliance to cGMPs and internal requirements. Assists in providing training for facility staff on GMPs, GLPs, and internal QA procedures
- Follow instructions precisely and recognize deviations
- Excellent written and verbal communication skills. Ability to provide basic feedback on compliance documents. Ability to communicate effectively (up, down, and laterally) with others
- Assist with maintenance of the Document Management System
- Act in a super user capacity for electronic elements of the Quality Management Systems to assist local users (e.g. MasterControl)
- Liaise with the corporate quality functions as required
List of Typical Skills For a QA Compliance Resume
Skills For QA Compliance Specialist Resume
- Prior experience in a cGMP regulated environment. Strong working knowledge of GMPs and Quality systems
- Excellent verbal, written, and presentation communication skills. High attention to detail
- Effective leadership skills; required to lead and direct the work of others
- Excellent strategic, collaboration and presentation skills
- Good understanding of solid oral dosage form manufacturing processes and QC testing
- Relevant experience and a particular skill set in their area of expertise that adds value to the business; ideally in a manufacturing, preferably GMP setting
Skills For QA & Compliance Supervisor Resume
- Proactive, analytical trouble shooting skills
- Advanced leadership skills including ability to lead across function team and work across boundaries
- Effectively (diplomatically) present information and respond to questions from groups of managers, customers, and regulatory agencies
- Knowledge or prior experience with Cell Therapy and or Blood Products
- Experience with Validation within a Pharmaceutical environment required
- Verbal and written communication skills (fluent in English)
Skills For Research QA & Compliance Lead Resume
- Excellent working knowledge of current, international, and company regulatory compliance requirements and operating procedures, including (but not limited to)
- GMP manufacturing, testing, documentation, and support experience
- Experience managing GMP quality assurance auditing and compliance activities for drug substance / drug product
- A positive and flexible approach is required to operate in DB’s constantly changing environment
- Ensure that a system is in place to manage complaints handling and investigations and ensure its effectiveness
- Pharmaceutical industry experience directly related to QA/Regulatory Compliance; working knowledge of cGMPs and FDA/DEA regulations
- Experience in Food Manufacturing Facility
Skills For QA Compliance Manager Resume
- Experience in the following programs is desired
- Experience in a similar role in the Pharmaceutical industry managing teams
- GMP compliance and training experience
- Previous auditing and investigation experience
- Supervisory experience in food and/or beverage manufacturing
- Demonstrated aptitude in translating corporate policies into compliance – e.g., Corporate Security and Regulatory Affairs Policies & Procedures (CSRA P&Ps)
- Performs internal quality system inspections (process/facility/equipment/validation) and review of corresponding regulatory documentation to ensure compliance
- Serve as primary contact for regulatory agency inspectors. Lead the development of responses, CAPA implementation and effectiveness checks
- Moderate to advances experience in Excel and PowerPoint
Skills For Senior Manager, IT QA & Compliance Resume
- Experience in a pharmaceutical company or other related industry, ideally in
- Direct consumer or pharmaceutical regulatory experience
- Demonstrated ability to development staff to full potential
- Quality Assurance compliance experience
- Business process management/quality process improvement experience
Skills For QA Compliance Auditor Resume
- Demonstrated proficiency at critically reviewing quality documentation (e.g. procedures)
- Hands on Audit experience
- Strong knowledge of local, federal and international regulations
- Demonstrated ability to work with internal and external colleagues
- Or combination of education and experience equivalent to
- Working knowledge of domestic and international drug regulations and standards including FDA regulations and guidance, European directives, and ICH guidelines
- Working knowledge of Pharmaceutical Quality Management Systems and their electronic applications
- Support training activities including development and maintenance of training matrices, training folders, delivery of training
Skills For Oxo-QA Compliance Manager Resume
- Efficient in compiling, managing and interpreting data from various departments as well as documentation from clients and their affiliates
- Develop and maintain product testing standards, and oversee all testing, releasing procedures, and product claims
- Prepare and process quality reports by collecting, analyzing, and summarizing data
- Develop and integrate a Quality Training Manual for manufacturing vendors, including quarterly score cards
- Key areas to be monitored include training, change management, onboarding / offboarding, GxP documentation, and security metrics
Skills For QA-compliance / Jaws Resume
- Knowledge of deviation, CAPA, Compliant, BPDR, Recall, Change Control, manufacturing processes, Packaging process, Regulatory inspection, technical writing
- Independent working requiring minimal supervision
- Motivated and self-starter demonstrating a solution-orientated working style
- Complete understanding and application of GCP principles, concepts, practices, and standards. Full knowledge of industry practices and GCP auditing
- Provide innovative ideas to improve quality and compliance that create value including seeking new information and external insights
- Facilitate decisions/recommendations by framing issues, presenting options and objective advice,
- Assist in authoring/compiling on-demand, monthly, quarterly and annual summaries and metrics associated with compliance activities
- Provides coaching and mentoring to CAPA owners to ensure CAPAs are compliant with regulations and internal procedures as required
- Works with the Global Compliance Manager to ensure Global Field Action program health by providing metrics and reporting
Skills For APL QA Compliance Specialist Resume
- Assists with developing and preparing correspondence to external government agencies and external customers
- Review and approves Standard Operating Procedures and corresponding in-process forms
- Responsible for drafting and reviewing SOP’s, Forms, Specifications required to support GxP requirements
- Support maintenance of Licenses including Manufacturing license and Wholesale Distribution Authorisation, ISO 13485 Certification
- Support, review and optimization of the company's pharmaceutical quality system by tracking and reporting key quality metrics for the site
Skills For Senior Manager of QA & Compliance Resume
- Pro-actively participate in optimization of the quality system by proposing new procedures, tools or through modification of existing ones
- Multi-task in a changing, deadline driven environment
- Customer service mindset, identifies opportunities to improve and contributes to problem solving
- Assists SMEs with initiating CAPAs within the required timeframe
- Manage the site auditing program
- Value adding, enthusiastic and inquisitive approach
- In an biopharmaceutical quality assurance, operational quality, or manufacturing leadership roles
- Certified Industry Analyst Certification for PMO Appendix-N testing of Drug Residue in Milk perferred
- Investigation and Problem Solving
List of Typical Responsibilities For a QA Compliance Resume
Responsibilities For QA Compliance Specialist Resume
- Proven ability to effectively initiate and drive change across the site
- Above average mathematic skills
- Working knowledge of current Good Manufacturing Practices and Quality Assurance systems
- Review and approve Technology Transfer, Validation and Equipment Qualification Protocols and Reports to ensure compliance to procedures and processes
- Demonstrated technical capabilities
- Experience with Global systems
- Experience in Quality Control, Quality Assurance, Documentation Control, Compliance
- Reviewing and revising various material specific documents, as needed
- React quickly to changing circumstances, clarifying and managing expectations, and finding ways to deliver solutions despite set-backs
Responsibilities For QA & Compliance Supervisor Resume
- Develops and manages GMP orientation program and ongoing GMP training for all GMP related departments
- Support site Inspection Readiness initiatives including self-inspections, monitoring audits, third- party and regulatory inspections
- Trained as a site Qualified Internal Auditor and participate in at least 2 monitoring audits a year and working towards the competency to be a Lead Auditor
- On-time completion of compliance objectives, including metric reporting, gap assessments, and Quality Management Review closure
- Monitor the workload of the Quality Compliance team, ensuring targets and standards of performance are achieved
- Applies knowledge and understanding of current regulations to make recommendations to senior staff
Responsibilities For Research QA & Compliance Lead Resume
- Review and approval of action items / commitment tracking items
- Maintain department Standard Operating Procedures (SOPs)
- High output while multi-tasking required
- Manages and performs GMP and related training
- Assist Quality Management with development of the Quality Plan, and Lead Quality Improvement projects. Assist in organizing QMR
- Assist with maintenance of the supplier audit schedule, supplier status tracking and approved supplier spreadsheets
- Thorough technical and regulatory knowledge of current pharmaceutical manufacturing processes and applicable current regulatory and GSK requirements
- Contribute to the master audit plan and assists project teams in implementing corrective and preventive actions,
Responsibilities For QA Compliance Manager Resume
- Manage team of field QCs and in-house QCs, ensuring policies and processes are followed
- Guide Design, Preproduction, and Production to ensure product specifications and testing requirements are well developed, communicated and implemented
- Assist with collection and reporting of quality metrics
- Coordinate data to complete necessary DEA and state reporting requirements for controlled substances
- Execution and monitoring of Site Quality Plan objectives
Responsibilities For Senior Manager, IT QA & Compliance Resume
- Act as owner or QA reviewer for internal deviations, CAPA and Change Controls
- Assist with supplier management activities ensuring Suppliers are appropriately qualified and re-assessed and that the Approved Supplier Lists and Audit Schedules are maintained
- Lead or participate in internal /supplier audits
- Assist with integration of new business lines into Quality System
- Assist with preparation and execution of back room activities for Regulatory / Notified Body Inspections
- Assist with compilation and analysis of data associated with performance of the Quality System (e.g. Management Reviews)
- Support additional projects related to Quality Systems as required
- Direct experience working with Quality Systems such as Supplier Qualification/ Management, Deviations, Change Controls, Training, and Document Management systems required
- MasterControl experience is advantageous
Responsibilities For QA Compliance Auditor Resume
- Planning, scheduling, coordinating, conducting and reporting GMP/GDP self-inspections and external audits of Actelion suppliers of drug substance / excipients and drug product contractors i.e. manufacturers, distributors, packagers and labs
- Self-confident and assertive with strong interpersonal and influencing skills, well able to manage all types of stakeholders and situations
- Manage, review and approve of qualification & validation documents of GMP equipment and GMP processes
- Praise good work, give constructive feedback and deal with performance issues promptly and sensitively
- Establish external QA audit and internal self-inspection frequency based on risk assessment
- Preparation and execution of the annual audit plan
- Manage, review and approve change controls, deviations and CAPAs
- Write, review, and/or approve internal quality system SOPs and other GMP/GDP and regulatory related documentation for Actelion globally and for affiliates
Responsibilities For Oxo-QA Compliance Manager Resume
- Evaluate, develop, establish, and maintain internal processes and procedures for compliance with GMP / GDP standards and for process improvement, including quality agreements with third parties and Actelion affiliates
- Review and approve site GMP required procedures and ensures alignment and compliance with Corporate Compliance, Global site reviews, and JnJ Policies and Directives
- Administer systems to monitor, track, and trend regulatory compliance i.e. deviations, CAPA, investigations, complaints, change controls etc
- Support site regulatory inspections. Participate in the preparation of document packages and responses to regulatory agencies
- Monitor changes in quality regulations and initiate required activities to keep the quality system aligned and compliant
- Travel time in this role is estimated at 25%
- Additionally, several years of experience in different operational positions in pharmaceutical product development and manufacturing of oral and sterile dosage forms
- Deep understanding of drug substance / drug product development, manufacturing process, quality control, packaging and distribution
- Deep expertise of (c)GMP and GDP, able to interpret and implement quality standards, pro-actively initiate and lead quality compliance activities and manage complex projects / tasks with competing priorities
Responsibilities For QA-compliance / Jaws Resume
- Provides appropriate coaching and performance feedback to all direct and indirect reports and assures that all team members are being developed
- Fluency in English (additional languages advantageous) and the ability to communicate clearly and professionally, both verbally and in writing is essential
- Maintenance of Quality Systems according to ISO or cGMP requirements
- Available to travel approx. 25% of the time
- Compliance with Regulatory requirements for Medical Devices and CE Marked products
Responsibilities For APL QA Compliance Specialist Resume
- Respect of cGMP applicable to Lonza Verviers
- Recognise when other teams and colleagues need support, and proactively offer assistance
- Identify potential cost/resource savings and take action to introduce
- Coordinates and hosts client audits. Reviews audit finding and completion of corrective actions. Provides periodic reports to management regarding status of audits and corrective actions. Manages response to audit findings
- Assists with establishing and revising Quality Agreements with clients
- Processes change controls for closure; ensures required tasks are completed
- Plans and conducts periodic audits of production and laboratory areas and external vendors, as required. Writes audit reports
Responsibilities For Senior Manager of QA & Compliance Resume
- Reviews completed batch records, related records, and validation packages for compliance to cGMPs and internal requirements. Reviews and approves SOPs, in-process forms, and validation protocols
- Prior experience in a cGMP regulated environment. Strong working knowledge of GMPs and Quality systems, and thorough understanding of how cGMP regulations and guidances apply to investigational and market licensed biologics
- Assess issues and make Quality decisions of a moderate scope within established procedures and policies
- Computer literate and knowledge of WordPerfect or MS Word, and Lotus or Excel. Demonstrated skills in developing and organizing systems for management of information
- Participate in New Business Development, Consulting, Health Outcomes activities and Strategic Planning
- Directs the QA/QC Coordinator and provides guidance on responsibilities
- Ensure the Innomar & 3PL facilities, operates and is in compliance with the Good Manufacturing Practices, Medical Devices, Narcotic and Natural Health Products regulations and Corporate policies
- Ensure that all activities and transactions occurring at the Innomar & 3 PL facilities are in compliance with SOP’s relevant to the Narcotic, Natural Health Products, Medical Devices and GMPs