Quality Compliance Specialist Resume Sample
Reece Pacocha
4774 Braun Mission,
Phoenix,
AZ
+1 (555) 957 3643
Work Experience
Quality Compliance Specialist
07/2015
-
PRESENT
Detroit, MI
- Maintain Drug Safety Mail box
- Assist in pulling records for FDA, DEA, and
- Prepares and coordinates all licensing inspections, contractual reviews, and accreditation surveys
- Acts as internal liaison and contact person for all licensing, contractual, and accreditation representatives
- Coordinates development of and submits all action plans to address licensing, contractual, and accreditation citations or areas of non-compliance; monitors the implementation of action plans to verify compliance
- Develops and monitors implementation of the internal Facility Monitoring Plan
- Reviews revisions to policies to verify they meet licensing, contractual, and accreditation requirements; maintain the policy and procedure manual for the facility
- Functions as the HIPAA Compliance Officer for the facility
Quality & Compliance Specialist
07/2012
-
06/2015
Philadelphia, PA
- Prepares meeting agendas, coordinates meetings, maintains meeting minutes, and develops other documentation related to on-going monitoring and evaluation of the program
- Collects and maintains data for licensing, contractual & accreditation standards and performance improvement. Prepares reports, data displays, charts, graphs, and other illustrations to support data collection, data analysis, and performance improvement
- Provides technical assistance and education to facility staff on licensing, contractual, and accreditation standards, including as-needed in-service training regarding the implementation of licensing, contractual, and accreditation standards
- Serves as a member of various internal and/or external teams, committees, or groups, representing the Novella Quality Assurance function
- Develops and prepares the initial documentation for new or improved processes and procedures, where appropriate
- Serves as a back-up for the VP Global Quality & Compliance for regulatory authority inspections
- In-depth knowledge of principles related to ICH GCPs and applicable 21CFR regulations. Familiarization with ISO 9001 standard and EU Directives
- In-depth knowledge of principles of quality management systems and associated processes
- Appreciation of auditing techniques and willingness to learn more advanced auditing skills
Associate Quality Compliance Specialist
05/2008
-
05/2012
Phoenix, AZ
- Excellent technical writing skills and fine attention to details, to include composition, grammar, punctuation and spelling
- Excellent professional presence and communication skills, both written and verbal, with all levels of staff, clients, and with the public
- Maintain collegial presence and cooperative demeanor under pressure and when working with difficult people
- Good working knowledge of MS Word, Excel, and PowerPoint
- Knowledge of Windows environment and the using the Internet search features
- Travel domestically and internationally, up to 40% average, with occasional intense travel
- Establish and maintain a systematic process for on-going monitoring and evaluation of the program
- Prepare and coordinate all licensing inspections, contractual reviews, and accreditation surveys
Education
Fisk University
2002 - 2007
Bachelor's Degree in Social Sciences
Professional Skills
- Strong interpersonal, written, and oral communication skills to communicate effectively
- Strong written and oral communication skills with ability read, interpret, and report data
- Demonstrated computer skills, preferably spreadsheet, word processing, database, and other applicable software programs
- Strong oral and written communication and technical writing skills
- Effective communication skills are essential with an ability to work effectively across AMO, Abbott and technical areas
- Understand validation principles and their application to quality approve validation protocols, validation reports and technical reports
- Demonstrated flexibility in responding to changing priorities and unexpected events while achieving high quality, compliant deliverables
How to write Quality Compliance Specialist Resume
Quality Compliance Specialist role is responsible for software, interpersonal, computer, microsoft, compliance, reporting, auditing, training, customer, excel.
To write great resume for quality compliance specialist job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Quality Compliance Specialist Resume
The section contact information is important in your quality compliance specialist 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 Quality Compliance Specialist Resume
The section work experience is an essential part of your quality compliance specialist 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 quality compliance specialist responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular quality compliance specialist position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Quality Compliance Specialist resume experience can include:
- Strong business and consultancy skills with knowledge and experience in HR
- Flexible, ability to work effectively in a fast-paced, dynamic environment with shifting and competing demands
- Prior experience working in a FDA or ISO regulated environment
- Proven strong attention to detail with a focus on quality
- Advanced knowledge of basic PC applications – MS Word, Excel, Access - and ability to use effectively in data analysis and documentation
- Effectively identify content, design and deliver training with regard to work processes and/or quality system elements
Education on a Quality Compliance Specialist Resume
Make sure to make education a priority on your quality compliance specialist resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your quality compliance specialist 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 Quality Compliance Specialist Resume
When listing skills on your quality compliance specialist 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 quality compliance specialist skills:
- Excellent interpersonal skills and the ability to resolve customer problems efficiently and effectively
- Good organizational skills and the ability to work under strict time constraints to meet customer requirements
- Good organizational skills and the ability to work under strict time constraints to meet the customer requirements
- Previous experience in delivering Quality System related training e.g. CAPA, Process Validation
- Experience in business operations of HR. Experience in analyzing data and communicating the results to the business
- Combined experience with food or ingredients and manufacturing experience
List of Typical Experience For a Quality Compliance Specialist Resume
1
Experience For Quality & Compliance Specialist Resume
- Ensure that within the CPO, a local GxP training program is established and training timely performed, documented and its effectiveness checked
- Demonstrated ability to independently function in a fast-paced environment while moving multiple simultaneous projects forward
- Experience in engineering in the high technology electronics industry
- Experience writing quality inspection instructions
- Lead and be a strong contributing member of cross-functional teams
- Coach process owners and SMEs on effectiveness measures
- Assist in the investigation and coordination of customer complaints and assess need for implementation of effective corrective or preventive actions
2
Experience For Senior Quality Compliance Specialist Resume
- Green Belt qualified or demonstrated knowledge of statistics in an industrial environment is desirable
- B.SC. in Pharmacy, Chemistry, Microbiology, Biotechnology, or Biochemistry or equivalent (education/experience)
- Demonstrated ability to, or aptitude to learn how to, manage and lead change
- Experience with quality and process improvement methodologies and tools
- Routinely demonstrates clear and direct written and verbal communication
- Ensure site readiness for regulatory and corporate (GQA) inspections, prepare responses track observations and maintain the closure evidence folders
- Review & draft proposals to implement changes to the Quality System procedures s as needed to maintain compliance and improve effectiveness and efficiency
- Coordinating appropriate assigned elements of the Quality System, ensuring full compliance by all relevant plant personnel with its requirements
3
Experience For Associate Quality Compliance Specialist Resume
- Understanding of SQF standards
- Coordinating internal audits and Management Review data collection processes
- Understanding of customer specifications for cosmetics and workmanship, customer drawings and mechanical specifications
- Understanding of typical quality tools (e.g. 8D, statistical process control, PFMEA and control plans)
- Responsible for establishing, managing and implementing Quality audits including internal and supplier audits
- Assist in identifying and analyzing the Training needs of designated functional areas
- Assist with maintenance of the AML Quality program documentation including policies, procedures, and reporting recordkeeping
- Participates in internal and external audits of Merit's quality system, including audit planning, execution, and audit follow up activities
4
Experience For External Quality Compliance Specialist Resume
- Identifies record based risks and remediation strategies through regular program compliance monitoring and reporting
- Responsible for internal and external audit program including trending of data
- Lead training courses, prepare and distribute training materials as required
- Identify business needs translated into training requirements or training/instructional system needs
- Support the design through conducting and monitoring courses
- Conduct needs assessments on a regular basis to develop future training programs that assist in business issue resolution, team-building or procedural updates
- Manage training program and ensure required training is completed by Managers and Supervisors
- Provision of monitoring and trending metrics associated with change control and other site quality systems
5
Experience For Senior Quality & Compliance Specialist Resume
- Ensure all plant personnel are fully aware of quality requirements (where relevant) by providing the necessary training
- Responsible for assuring the quality and compliance of testing for commercial and clinical products manufactured at the facility
- Knowledge of BMO Financial Group products, service, organization and interrelationships, branch banking. Banking knowledge is an asset
- Internal liaison and contact person for all licensing, contractual, and accreditation representatives
- Develop all action plans to address licensing, contractual, and accreditation citations or areas of non-compliance; monitors the implementation of action plans to ensure compliance
- Review revisions to policies to ensure they meet licensing, contractual, and accreditation requirements; maintain the policy and procedure manual for the facility
- Ensure all clinical record documentation and other program practices meet the requirements of all licensing, contractual, and accreditation standards
6
Experience For Site Quality Compliance Specialist Resume
- Ensure all revised or new job descriptions meet the requirements of all licensing, contractual, and accreditation standards
- Prepare meeting agendas, coordinate meetings, maintain meeting minutes, and develop other documentation related to on-going monitoring and evaluation of the program
- Relevant product testing experience
- Experience in Quality, Compliance and Audit in a pharmaceutical or healthcare manufacturing environment
- Incorporates risk-based thinking into business processes and procedure documentation
- Responsible for managing the supplier quality program
- Provides managerial leadership, coaching/ feedback and development for direct reports and business partners
7
Experience For Quality / Compliance Specialist Resume
- Review applicable federal and state regulations to ensure program consistency and compliance for the areas of both Training and EHS
- Co-coordinate trainees’ needs, content and delivery of technical training curriculums
- Ideally knowledge of applicable federal and state regulations to ensure program consistency and compliance for the areas of both Training and EHS
- Maintain and review all food safety related recording forms
- Manage the training program for the standards
- Stay current with key regulatory and certifying agency guidelines and regulations
- Plans and conducts monthly cGMP audits of manufacturing activities to assess compliance with all pertinent regulations as well as with company SOP’s
- Assists with internal GMP training
8
Experience For Kalite Uyum Sorumlusu Quality & Compliance Specialist Resume
- Identify areas and procedures in need of improvement and implement corrective actions and processes to achieve sustaining results
- Perform and assist with miscellaneous QA activities including customer and regulatory audits
- Assist in cultivating a quality culture through participation in cross-functional teams
- Knowledge of HR Operations and business practices, identification, research, gap analysis and solution proposing
- Think innovatively and propose solutions for process optimization using technology and lean principles
- Management of Exception Reporting & Planned Deviation Systems
9
Experience For Clinical Trials Quality & Compliance Specialist Resume
- Data, trend analysis & reporting on an adhoc and routine basis
- Ensure Quality System documentation is thorough, complete, and compliant. Ensure compliance to training requirements is maintained
- Provide support as needed for Patient Access and Availability Study (PAAS) and corresponding corrective action plans
- Investigate customer product complaints following corporate SOP’s and document information into complaint management system
- Employ critical thinking
- Support activities related to the Medical Device Quality Management System ensuring compliance to all applicable medical device regulations
- Prepare data/presentation representing status of compliance to procedures and regulations
- Liason to External Manufacturing and Materials Quality
10
Experience For Business Quality Compliance Specialist Dach Resume
- Maintain all processing and regulatory compliance records
- Administer Business As Usual activities to ensure site compliance to marketing authorizations
- Monitor and review documents regarding products, raw materials and test methods based on compendial updates
- Work closely with Lab personnel for protocol generation and review for Phase II lab testing (OOS Investigations)
- Provide support for initiation and investigation of deviations originating from the QC laboratory
- Perform verification /inspection of outgoing materials for Human Factor studies
- Perform or review First Article and incoming materials inspections of components that have been manufactured per development specifications
- Prepare data/presentatations representing current status of compliance to procedures and regulations
- Proactively update the documentation when required and communicate to the teams if any changes occurred. Provide training on changes when required
List of Typical Skills For a Quality Compliance Specialist Resume
1
Skills For Quality & Compliance Specialist Resume
- Good communication and interpersonal skills and able to communicate and interact with all levels of people, internal and external parties
- Prior experience within the Pharmaceutical industry
- Effectively communicate with internal departments, team members and partners
- Intermediate skill and experience with Microsoft Excel and Microsoft Word
- Interpersonal/written/verbal communication skills
- Superior level of computer and software skills
2
Skills For Senior Quality Compliance Specialist Resume
- Software skills (Microsoft Word, Excel, PowerPoint, document management systems)
- Self-driven, results oriented, effectively works independently
- Works effectively with confidential knowledge and materials
- Agile in leading multiple priorities including owning and balancing project management in addition to daily work
- Manage deadlines while balancing competing priorities
- Experience working in a QA / Compliance department of an API manufacturing facility with focus on product release
- Experience in preparing and managing documents for regulatory agencies
3
Skills For Associate Quality Compliance Specialist Resume
- Experience monitoring and applying Federal, State and Regulatory agency requirements
- Experience in analyzing data and communicating the results to the business
- Escalates within team for solution prior to escalating to management
- Is able to deal with changing priorities in a flexible manner
- Demonstrated technical writing capability with the ability to write reports, business correspondence, and procedure manuals
4
Skills For External Quality Compliance Specialist Resume
- Ensure that PV computerized systems are assessed using Risk Assessment for GPvP rele-vance to enable their validation where required
- Experience in the systems quality discipline with extensive backend, integration project testing
- Quality Assurance experience in Manufacturing
- Experience in clinical or Managed Care setting
- Experience working with clinical staff
- Experience in planning Committee meetings
5
Skills For Senior Quality & Compliance Specialist Resume
- Experience creating reports related to quality improvement/performance outcomes
- Experience in an HR environment and working with HR data
- Strong understanding of data management and analytics principles
- Quality Improvement experience in health and/or social service agency setting
- Quality improvement experience in healthcare/social service agency setting
- Experience in complex organizations and matrix reporting relationship
6
Skills For Site Quality Compliance Specialist Resume
- Multi-task and prioritize competing demands/work load
- Experience in review or audit regulated documentation, including expertise with Microsoft Word, Excel and RCA Tools
- Maintain facility good standing
- Three (3) years of nursing experience in a large, complex healthcare organization
- Utilizes quality system in compliance with current good manufacturing practices
- Delivers effective training and awareness programs
- Demonstrated ability to problem-solve and manage multiple tasks while paying attention to details
7
Skills For Quality / Compliance Specialist Resume
- Previous Quality Compliance experience
- Operates with high level of independence to investigate and resolve compliance issues, lead projects, plan and implement improvements, and achieve goals
- Minimal 3 year experience in Pharmaceutical Industry in a Q&C role
- Operational knowledge of good distribution practices and regulations
- Excellent written and spoken Dutch and English
8
Skills For Kalite Uyum Sorumlusu Quality & Compliance Specialist Resume
- Former or current experience with Adverse
- Work experience in Quality Assurance
- Demonstrated independent worker with ability to focus
- Work experience with quality improvement and/or compliance measures in healthcare and/or a social service agency
- Experience in Quality Management
9
Skills For Clinical Trials Quality & Compliance Specialist Resume
- Foster communication with key stakeholders in order to properly plan and prioritize workloads based on potential impact to clinical study and commercial supply
- Proactive with proven ability to work under own initiative to accomplish objectives and timelines
- Ensure superior customer service to internal customers, with strong written and verbal communication
- Experience in a data quality and compliance function
- Demonstrates knowledge of all applicable compliance and legal requirements of the job based on the scope of practice of the position
- Industry experience in a QA function
- Work experience in Compliance, Internal Controls, Quality Assurance or Quality Management
- Strong project management with hands-on-delivery of end-to-end improvement projects
- Experience of the key customers’ business processes and practices
10
Skills For Business Quality Compliance Specialist Dach Resume
- Willing to travel up to 10% for training, to audit associated client sites or attend off site meetings
- Working knowledge of cGMP documentation and regulations, ISO Standards, and corrective action procedures
- Training coordination, follow-ups and preparations
- Maintaining the electronic systems used for Change Control, Deviation Management and CAPA
- Training of personnel on change control and other quality system processes
List of Typical Responsibilities For a Quality Compliance Specialist Resume
1
Responsibilities For Quality & Compliance Specialist Resume
- Act as the point of contact for quality defects, customer complaints related to product defects, and manage them as per the Non-Conformance process. Also open CAPA’s (Corrective Actions/Preventive Actions) where necessary
- Develop and Monitor processes or procedures and recommend systems that ensure effectiveness of training delivery
- Demonstrated ability to influence management, business groups, and Subject Matter Expert (SME)’s toward a recommended action
- Strong knowledge of Health Canada’s GMP Regulations
- Narcotic and precursor experience could be an asset
- Review DHCS All Plan Letters (APL) and Policy Letters, reconciling and revising policies and procedures to ensure compliance
- Analyze and provide interpretation on McKesson’s Temperature monitoring system and route temperature profile system
2
Responsibilities For Senior Quality Compliance Specialist Resume
- Familiarity with regulatory reporting requirements for medical devices (e.g. MDRs, Vigilance reports, etc)
- Basic knowledge of Statistics for handling of data and use of Statistical tools
- Coordinate all systems, related to the Safe Quality Food Level 2 and 3 certification
- Function as the document control administrator for the facility
- Update and manage all controlled plant and corporate documentation
- Manage manual or internet based document system and serve as the administrator for the program
3
Responsibilities For Associate Quality Compliance Specialist Resume
- Lead the audit for the standard
- Provide backup to the QA Manager as an SQF practitioner at level 2 and level 3 activity
- Lead the annual Management Review of the system at the facility
- Coordinate corrective action program for audits at the facility
- Food Safety Modernization Act record review
4
Responsibilities For External Quality Compliance Specialist Resume
- Chain of Custody Compliance
- Audit the system for compliance and manager audit corrective actions
- Follow up on activities and closure of corrective action programs
- Assist the QA Manager to oversee Pest Control Programs
- Assist the QA Manager for the facility audits and inspections
5
Responsibilities For Senior Quality & Compliance Specialist Resume
- Provide support to QA department for special projects
- Manage the AFSR Rochester site’s Quality Systems and procedures to ensure they comply to all required customer and industry requirements. These include, but are not limited to (AS9100, ISO9001, NADCAP, RR:SABRe, S1000, ASQR01)
- Perform external audits of suppliers to guarantee the supplier’s conformity to all AFSR quality requirements
- Prepare clear and concise written report of audit observations, including an assessment of compliance. Assesses adequacy of action plan and conducts follow up activities as needed to monitor
- Ensure completion, follow-up and documentation of corrective actions taken in response to product safety and third party audit findings
- Assist in the interpretation and implementation of existing and new regulatory requirements and industry best practices and review deviations, change controls and corrective/preventative actions to ensure EFfCI GMP expectations are being met
6
Responsibilities For Site Quality Compliance Specialist Resume
- Manage dealings with Contract Pest Control service to ensure that all activities related to pest control at the Kenedy plant are followed in accordance with applicable regulations
- Conduct weekly review of process batch records and department cleaning checklists to ensure that no critical errors have occurred or, if these occur, that they are fully investigated
- Schedule and oversee annual EFfCI third party certification audits and ensure that site audit response CAPAs are completed in a timely manner. Tracks investigations to ensure closure
- Support the client in preparing for Internal and External audits
- Work closely with Operations to identify, evaluate, and recommend solutions to issues identified in the performance of cGMP audits
- Assist in development of new GMP projects
- Maintain a safe workplace that complies with company policies and standards
- Reads and comprehend the applicable Service Level Agreements, helps achieve the Key Performance Indicators and scores favorably on the client satisfaction surveys
- Perform facilities, utilities and maintenance related Non-Conformance Investigations and CAPAs
7
Responsibilities For Quality / Compliance Specialist Resume
- Conduct self-audits of areas and 3rd Party Vendors within JLL’s scope of work
- Development and implementation of risk assessment programs
- Review batch records, specifications, SOPs, data, and other supporting documentation related to the manufacturing, testing, packaging, and labeling processes to assess compliance with the relevant dossier or marketing authorization
- Determine source of any differences or issues found upon review of the documentation
- Collaborate with cross-functional departments to resolve discrepancies and ensure compliance
8
Responsibilities For Kalite Uyum Sorumlusu Quality & Compliance Specialist Resume
- Assess discrepancies for product impact and author justifications where possible
- Prepare and review documentation package to support product release for management approval
- Support product release performed by Qualified Person at contract manufacturers and Regeneron Ireland
- Perform other support responsibilities as requested
- Support QA project initiatives for a broad range of topics as the Product Quality group evolves
- Comprehension of quality and cGMP principles and relevant global regulatory guidelines
- Familiarity with CMC-related CTD structure and content
- Review and approve SOPs, forms, test methods and log data within document management system
9
Responsibilities For Clinical Trials Quality & Compliance Specialist Resume
- Attend meetings and speak to the project and change processes to identify quality requirements
- Responsible for review and approval of associated change control documents, and other documents such as
- Ensure that during the life-cycle of all projects relevant to lab compliance and continuous improvement, support is provided to all activities required to deliver results in a timely manner.These responsibilities include but are not limited to
- Manage the site’s Quality Systems and procedures to ensure they comply to all required customer and industry requirements. These include, but are not limited to (AS9100, ISO9001, NADCAP, RR:SABRe, S1000, ASQR01)
- Acts as a subject matter expert for several information systems utilized by HRSC and actively participates in training and enhancements for system optimization
- Performs on-going credentialing analysis on job descriptions and applies critical thinking to ensure regulatory requirements are met. Supports position mapping where gaps occur, and maintains multiple supporting data sources; escalates to business partners as needed
10
Responsibilities For Business Quality Compliance Specialist Dach Resume
- Delivers high quality customer service support to internal and external clients, including collaboration with SME's and business partners to ensure overall timely resolutions to inquiries or issues
- Uses critical thinking and root cause analysis to responds to inquiries; researches, gathers supporting information, and SME's feedback to resolve problems
- Knowledgable on current actions and changes with regulatory agencies, federal and state, with specialization in HR, drug screening, EEO, licensure, certifications, I9s, and adjudications
- Knowledge regarding protection of confidential/private information related to patients, members, employees and ability to apply properly
- Assists with requests for field audit and survey support for pre-employment requirements
- Present data in a logical, concise manner to all levels of the organization
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