Compliance / Quality Specialist Resume Sample
Juston Green
615 Ken Flat,
New York,
NY
+1 (555) 810 0562
Work Experience
Quality Assurance Compliance Specialist
11/2015
-
PRESENT
Boston, MA
- Relevant documentation regarding complaint files is compiled and included in the Quality Management System
- The complaint is codified according to the procedures and according to the information received
- The reportability to the authorities is determined according to the internal procedures
- Imagery supporting the report is collected and reviewed for evaluation
- Product for evaluation is shipped and evaluated
- The vigilance report is prepared and approved according to the internal procedures, the authorities are informed and the vigilance files are part of the Complaint file
- The Device History records are reviewed
Compliance / Quality Specialist
01/2012
-
08/2015
Philadelphia, PA
- The root cause is identified when applicable
- The complaint file is closed within the time established
- The PRA’s and CAPA’s linked to the investigation are part of the file
- The trends for the failure are performed, reviewed and included in the file
- The customer is informed when required
- Provides technical support for external and internal customer inquiries
- Builds knowledge of the company, processes and clients and/or customers
- Applies team effectiveness skills, listening and integrating diverse perspectives from across the work group; contributes and adds value to the achievement of team goals
Quality Specialist Industry Standards Compliance
05/2006
-
09/2011
Dallas, TX
- Writes technical documents such as methods, specifications, method validation protocols and reports, method transfer protocols and reports based on corporate policies and SOP's, compendial, ICH and FDA regulatory guidance
- Evaluates compendial documents, and reviews procedures for laboratory compliance
- Generates change requests required for analytical documents, and routes documents for review and approval. Maintains hard copies and electronic file of technical documents
- Timely provide the QC documents required for CBE, PAS and ANDA submission to RA
- Managing the satellite copies of method specifications, and technical documents
- Collaborates with colleagues and external partners to achieve individual and department goals
- Ensure compliance with cGMP’s, DEA regulations and site operating procedures under the direction of QC Management
- Ensure Lab Event/Out-of-Specification and Out-of-Trend investigations are properly conducted and closed on a timely fashion
- Trains, coaches, and monitors QA Compliance Technician group with some direction from QA Compliance Supervisor to ensure department possesses necessary skills to achieve department goals and objectives
Education
Southwest Minnesota State University
2001 - 2006
Bachelor's Degree in Finance
Professional Skills
- Strong communications skills, both written and oral, to effectively implement and facilitate new ideas, processes, and programs
- Experience in a GMP QA role, ideally with prior experience acting as a QA point of contact for clients in a contract manufacturing environment
- Strong written and communication skills including group presentation and training
- Strong analytical, research, written, editing, and verbal communication skills
- Strong oral and written communications skills, including ability to communicate to all organizational levels
- Strong organizational skills, comfortable managing multiple project simultaneously
- Excellent interpersonal, cross-cultural, communication, negotiation and problem solving skills
How to write Compliance / Quality Specialist Resume
Compliance / Quality Specialist role is responsible for events, training, travel, finance, credit, database, mac, auditing, shipping, reporting.
To write great resume for compliance / quality specialist job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Compliance / Quality Specialist Resume
The section contact information is important in your compliance / quality 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 Compliance / Quality Specialist Resume
The section work experience is an essential part of your compliance / quality 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 compliance / quality 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 compliance / quality specialist position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Compliance / Quality Specialist resume experience can include:
- Strong interpersonal skills and the ability to assist personnel in a matrix organization, ability to
- Strong interpersonal skills and the ability to
- Highly ethical, self-motivated and self-directed; works effectively independently as well as in a team
- Computer skills, specially with Excel,PowerPoint and Visio programs
- Prior audit and inspection experience required
- Knowledge of computers to effectively utilize common office applications (e.g., Outlook, PowerPoint, Word, Excel and Adobe Acrobat)
Education on a Compliance / Quality Specialist Resume
Make sure to make education a priority on your compliance / quality specialist resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your compliance / quality 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 Compliance / Quality Specialist Resume
When listing skills on your compliance / quality 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 compliance / quality specialist skills:
- Strong analytical skills, ability to analyze data, trends and draw conclusions
- Excellent computer skills and competence with Microsoft Office (Word, Excel, PowerPoint)
- Strong interpersonal skills necessary to work with multifunctional teams
- Strong personal leadership with demonstrated competency interfacing with department lead is
- Demonstrated ability to prioritize, execute tasks to achieve goals, and meet project timelines
- Strong personal leadership with demonstrated
List of Typical Experience For a Compliance / Quality Specialist Resume
1
Experience For Quality Assurance Compliance Specialist Resume
- Measures efficiency and suitability of CQS by tracking a group’s defined quality metrics and then performing trend analysis on the data
- Leads simple assigned customer complaints, including investigation; root cause analysis, corrective action, and timely written response back to customer
- Assist in providing technical support to Supplier(s) and Agropur facilities to improve Supplier Quality Performance when assigned/applicable
- Assist QA Compliance Supervisor in audits when necessary
- Develop (when necessary) and help verify quality related programs assigned to ensure the facility maintains 3rd party and customer audit requirements, as well as, the corporate Quality Expectations Manual (QEM)
- Maintains the certification submissions program under QA Compliance Supervisor guidance to ensure all products are properly being managed by the designated certifying bodies (examples: NSF Sport, Gluten Free, Kosher, Halal, Organic, etc.)
- Experience and/or certifications in construction based technical reviews and inspections
- Help manage and maintain the Supplier Quality and Regulatory documentation in the computer system
2
Experience For Grandbridge Agency Quality Control Compliance Specialist Resume
- Responsible for food safety quality
- Knowledge of QMS and CAPA related tools or
- Review / approval of MFG COA’s
- Focused QA Representative for review/approval of Final Reports, CoA’s, Non-Conforming Events (NCEs) and CAPA’s. Ensures site adherence to Quality Systems
- Applies CQS requirements to an organization’s specific business model
3
Experience For Quality Specialist Industry Standards Compliance Resume
- Keeps abreast of changes to significant regulatory and applicable agency’s standards through communication with Regulatory Affairs and other external agencies
- Acts as a CQS liaison to Cerner’s Regulatory Affairs/Quality Assurance group
- Process all Support Central workflows in Product Questionnaires [PQ’s], New Raw Material Introductions, Sub/Alts, and all MMOC to meet the assigned cycle time targets
- Monitors and audits the group’s team-level processes to ensure consistent compliance
- Keep up-to-date on changes to significant regulatory and applicable agency’s standards through communication with Regulatory Affairs and other external agencies, as applicable to the associate’s domain
- Collaborate with Grandbridge Risk Management team to establish, enforce and monitor processes and procedures to be established pursuant to BB&T’s requirements with respect to Bank Secrecy Act/Anti-Money Laundering (BSA/AML) requirements
- Assist Grandbridge Analysts with various tasks from time to time, including the loading of documentation into Grandbridge’s DMS and Docstore systems, which can be a time consuming task when deal flow is high
- Responsible for the handling of change requests from the departments, such as Master Batch Records (MBRs), Specifications (SPECs), General Changes (GENs), etc.
4
Experience For Compliance Quality Specialist Resume
- Successfully completed 3-years technical or scientific apprenticeship or similar quslification
- Proficient in the use of MS Office Tools (Word, Excel, Outlook)
- Ideally user knowledge in Trackwise and/or JDE systems
- Customer orientation, organizational and communication-related strengths
- Ensures site adherence to Quality Systems
- Compiles and reviews raw data / laboratory test results, including Final Reports and CoA’s, in accordance with cGMP, cGLP, Code of Federal Regulations (CFR), Points to Consider (PTC) guidelines and internal procedures in an efficient and timely manner. Assure that any observations/deviations are properly investigated and explained
- Manage the Stability Program: obtain and review stability studies, confirms product expiry terms based on data analyses
- Manage the Annual Product Quality Report Program: participates in the annual product review by obtaining and reviewing documents related to the products; confirms product specifications are current within the master document files, confirms all changes have been documented, compiles trend-analysis data and writes a trend-analysis report
- Manage control of changes: helps evaluate change requests for equipment, primary and secondary components, processes, systems and various types of documents; monitors follow-up with parties involved; ensures that deliverables are compliant pursuant to the change; closes changes upon implementation
5
Experience For Quality Specialist, Compliance Resume
- Validation Management: ability to lead and manage Commissioning/Validation/Re-qualification projects for 3 sites and to ensure quality and compliance with regulatory requirements
- Develop and Maintenance of client Quality Agreements and internal procedures to support the agreements
- Preventive Maintenance and Pest Control Management: provide quality oversight to ensure a compliant Preventive maintenance, EM and pest control program
- Deviation Management: Investigate and document any discrepancy recorded during product handling and ensure product disposition decisions in conjunction with client
- Controlled Drug/Narcotics Handling: Coordinate the site’s controlled substance handling, inventory, destruction and compliance
- Support the QA department in ensuring Innomar GMP facilities operate and are in compliance with Good Manufacturing Practices and applicable Health Canada regulations and corporate policies
6
Experience For Quality Assurance & Compliance Specialist Resume
- Assist in the development and implementation of Quality policies and procedures to ensure that regulatory compliance is maintained or enhanced
- Assist in product launch activities as assigned
- Work with other functional areas to resolve issues related to information for regulatory submissions
- Provide regulatory and Quality Assurance guidance and support to potential new clients as assigned
- Provide assistance to the QA Senior Manager and Director, Quality Assurance as required
- Monitors compliance with all abbvie policies and procedures in addition to all federal/state/local/global and pharmaceutical laws and regulations
- Evaluates, analyzes and trends quality indicators
7
Experience For Quality Control Compliance Specialist Resume
- Prepares reports of quality operations, productivity as well as monthly quality metrics
- Supports investigations and provides metric collection for timely resolutions to exceptions events, out of trend events, facilities and document Risk Management activities (e.g. FMEA
- Assists with planning and conducting internal compliance audits of all operations within the facility. Follow up on audits to assure that action plans are developed and completed in a timely fashion
- Computer literate with a strong proficiency in Microsoft Office
- Strong knowledge in computerized systems such as Document Management, ERP system, and/or CARISMA Plateau system
- Support site Inspection Readiness initiatives including Self Inspections, Monitoring Audits, and Independent Business Monitoring
- Manage GMP documents by writing, reviewing, and/or managing document workflows
- Prepares QA presentations suitable for management and external customers
- Manage QA lists, spreadsheets and databases as required by site operations
8
Experience For Quality Specialist, Systems & Compliance Resume
- Participates in Improvement initiatives and assures quality compliance
- Supports product complaint program for the organization
- Oversee the internal and supplier auditing program. Responsibilities include development of an annual schedule, coordinating internal and supplier audits, and reporting on internal and supplier audit schedule adherence
- Responsible for tracking metrics for the Quality department and presenting to management
- Management and approval of Quality agreements and drafting Annual Product reviews as required
- Work productively with personnel from various departments
- Support Supplier Quality Management
- Trained as a Inspector for Self Inspections and participate in >25% of department’s Inspections
- Evaluate metrics and Key Performance Indicators (KPIs) for management of risks and compliance
9
Experience For Compliance / Quality Specialist Resume
- Capable to troubleshoot problems
- Work in a cross-functional team as a team member
- Act as quality control compliance specialist on complex construction projects and enforce contract requirements
- Verify the quality and acceptability of construction materials and authorize that the entry into the contractor payment system
- Collaborate with the lead inspector to ensure tests are performed, documented and submitted to the project management office in accordance to the specifications and required timeframes
- Ensure that the contractor's quality control program meets required standards for all projects assigned to the project manager's office
- Facilitate and resolve disputes between contractor's quality control and ODOT's quality assurance tests
10
Experience For Quality Assurance Compliance Specialist Resume
- Prepare and maintain the test summary for materials on each project
- Review contractors' and agency test results for completeness, accuracy and acceptability
- Train, and mentor other inspectors, junior inspectors and interns
- Review monthly estimates and recommend changes to estimated quantities based on work complete
- Document quantity and quality of construction materials, verify proper payments to contractors, and assemble project records for final acceptance
List of Typical Skills For a Compliance / Quality Specialist Resume
1
Skills For Quality Assurance Compliance Specialist Resume
- Extensive experience writing and/or reviewing/approving Laboratory Investigations / Deviations / CAPA’s preferable
- Strong working knowledge of Microsoft Office (Word, Excel, PowerPoint, & Outlook)
- In an inter-departmental team environment, works to facilitate/incorporate effective quality practices for new and existing clients
- BS or MS in a scientific field with at least 3 - 5 year’s of experience in the pharmaceutical industry preferably in a GMP laboratory setting
- Strong knowledge of Cigna systems including CPF, Proclaim, PMHS, SANP, and Facets
- Experience in regulatory or compliance in the tissue banking, medical device or similar field
- Experience performing audits
- Prioritize and perform work while adhering to deadlines
2
Skills For Grandbridge Agency Quality Control Compliance Specialist Resume
- Work experience in a pharmaceutical manufacturing company
- Experience in projects involving asphalt and concrete applications
- Experience in material testing, quality control/compliance and/or construction project inspection
- Solid knowledge of IT structure and Information Database Systems (such as Oracle Argus,Trackwise)
- Previous experience in healthcare, pharmaceuticals or clinical desired but not required
- Highly self-motivated with a strong attention to detail
- Work semi-independently, and have demonstrated ability to interact with others in a cross- functional environment
- Experience with health authority inspections
- Experience in analytical tools such as MS Excel, Minitab, MS Access, Toad, Cognos Hyperion, SAS, etc
3
Skills For Quality Specialist Industry Standards Compliance Resume
- Administrative background and experience in medical device or pharma data management (preferably Quality or Regulatory)
- Preferably knowledge or experience in Quality Systems, knowledge in anatomy, physiology and medical interventional procedures
- Demonstrated knowledge of the operations of water/wastewater facilities
- Valid Class of Ontario Certification in Water Treatment for work assigned
- In depth experience in laboratory regulatory requirements and industry standards required
- Experience in Quality Systems in the medical device field
- Demonstrated proactive approach to issue resolution with an ability to work well across departments and business partners
- Monitors and reviews the group’s team-level processes to ensure efficiency, effectiveness, and consistent compliance
- Working knowledge of insurance requirements and third party billing
4
Skills For Compliance Quality Specialist Resume
- Driving state vehicles on a regular basis requiring some occasional overnight travel
- Working knowledge of and quality and compliance standards at the state and federal levels (i.e., Medicare, Medicaid)
- Working knowledge of applicable US FDA, USP and state board regulatory requirements and
- Efficient in compiling, managing and interpreting data from various sources (e.g. from clients and their affiliates)
- Field work involves walking on rough terrain and stooping or bending around structures or equipment
- Track, trend and monitor Drug Product Operations information and data; prepare reports analyzing data and issuing reports as required
5
Skills For Quality Specialist, Compliance Resume
- Provide support during regulatory inspections by Health Canada and during quality audits by customers and third party auditors
- Develops QA training program and provides training to departmental personnel
- Support day to day compliance functions including planning, compilation and management of regulatory submissions
- Knowledge of GVP, government regulations and guidelines (EMA, FDA, PMDA) pertaining to pharmacovigilance
- Provide support to Drug Product Manufacturing team to ensure world-class DP supply quality, delivery and efficiency
- Organises, schedules and reports on the DP Manufacturing Business performance management process
- Partners with management to execute RFP (request of proposal) and financial activities for CMOs (contract manufacturing organizations)
- Oversee and execute shipping documentation requirements to and from CMOs
- Maintain, update and provide status of Drug Product Manufacturing activities via schedules and checklists
6
Skills For Quality Assurance & Compliance Specialist Resume
- Knowledge of applicable regulations and standards affecting Pharmaceutical Products (e.g. CFR 210/211, cGMP, DEA)
- Develop training programs and provide department services relevant to quality, customer service and related topics
- Workload involves tight time schedules and projects with competing deadlines
- Field work requires occasional lifting of 40-60 pounds
- Provide technical expertise to project inspectors and contractor personnel on testing procedures
- Coordinate with project inspectors and region quality assurance team to schedule all quality assurance testing
- Assist in writing contract change orders for material related items and prepare written correspondence to contractors
- Assist in improving Agropur’s Quality and Food Safety programs through continuous evaluation of/with Supplier(s)
- Adapt well to varying personality and work styles
7
Skills For Quality Control Compliance Specialist Resume
- Quality, processes, and compliance oriented
- Knowledge of controlled substances desired but not required
- Acts as the Primary Quality Assurance Representative for designated clients
- Review and approval of GMP Certificates of Analysis (CoA’s), deviations, and CAPAs
- Reviews, as necessary manufacturing batch records in accordance with current Good Manufacturing Practices (cGMP), and Good Laboratory Practices (GLP) for Nonclinical Laboratory Studies, as applicable. Monitor processes for adherence to established procedures/regulatory compliance
8
Skills For Quality Specialist, Systems & Compliance Resume
- Review and approve Non-conforming events (NCE) and CAPAs, Pre-review/ approval of pre-executed batch records for assigned clients, Post review of MFG batch records if required
- Evaluate compliance with QA processes, Equipment Qualification, and Computer System Validation
- Highly ethical, self-motivated and self-
- It is the expectation that AMRI employees exhibit safe work practices at all times
- Knowledge of FDA cGMP requirements, FDA PTC guidelines required, Knowledge of EU cGMPs highly desirable
- Review CMO records and support investigations if needed in accordance with Regeneron requirements
9
Skills For Compliance / Quality Specialist Resume
- Drive continuous improvement of operation systems and processes
- Stand /Sit/walk for long periods of time
- Regulatory Affairs or Quality Assurance Certification as asset
- Fluent in English and preferable two other European languages (Spanish and other)
- Knowledge of water/wastewater regulations
- Highly organized, efficient and self-motivated
- Team player who respects all functional levels internally and externally
- Field work involves exposure to extreme hazards of traffic, construction site hazards, construction equipment, and inclement weather
10
Skills For Quality Assurance Compliance Specialist Resume
- Field work occasionally requires work above the ground or water on platforms or machinery with appropriate safety equipment
- Represent Quality Assurance function as a team member for production, and laboratories giving technical and compliance input ensuring scale-up and pre-/post-approval inspection success
- Provide quality/compliance input and requirements for the development, testing, production, transfer, validation, and post approval changes of all products manufactured at the facility
- Conduct internal and external audits for compliance with regulatory
- Reviews water quality data received from the laboratories to ensure conformance to applicable legislation
- Prepare monthly and annual reports as required by Clients, Project Manager, Head Office and the Ministry of the Environment and Climate Change
- Coordinates development and maintenance of the Drinking Water Quality Management Standard (DWQMS), including Operational Plans, document controls, procedures, and standard operating procedures. Reports to Top Management on the performance of the QMS and any need for improvement
- Conduct routine chlorine residual analysis, turbidity readings and fluoride analysis
List of Typical Responsibilities For a Compliance / Quality Specialist Resume
1
Responsibilities For Quality Assurance Compliance Specialist Resume
- Prepare and maintain company Federal, State, International, or other regulatory body establishment registration and listings
- Audit of Internal processes, procedures and design records and files
- Report non-conformances and discrepancies and participate in continuous improvement functions
- Perform external Supplier audits, create formal audit reports
- Recognize and elevate critical regulatory/compliance issues to Quality Management
- Respond to customer requests for information related to the operations and compliance status of the company
2
Responsibilities For Grandbridge Agency Quality Control Compliance Specialist Resume
- Keep abreast of new or revised international regulations and guidelines to assess impact to company polices or procedures
- Represent the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties of Bone Bank Allografts
- Assist in projects that impact the Quality Management System. Report on progress against schedules,
- Assist in projects that impact the Quality
- Collect and prepare samples for submission to accredited labs
3
Responsibilities For Quality Specialist Industry Standards Compliance Resume
- Ensure optimal operations of water treatment processes through chemical dosage assessment and adjustment
- Maintain records as required by the regulators, the clients and the company
- Regulatory and executive customer complaints as well as written/verbal customer inquiries
- Knowledge of DWQMS
- Work with document reviewers to compile and review raw data, batch records and test results, including Final Reports and CoA’s, in accordance with cGMP, Code of Federal Regulations (CFR), Points to Consider (PTC) guidelines and internal procedures in an efficient and timely manner. Assure that any observations/deviations are properly investigated and explained
- Involved in activities geared towards procedural improvements: reviews and approves product-quality failure and non-compliance investigations; performs follow-up on corrective and preventive actions pursuant to an incident; performs trend analysis on systems and processes to ensure process optimization; reviews standard operating procedures; assists with internal and external audits
- Releases lots: approves manufacturing and packaging, master files; reviews batch records for manufacturing, packaging, testing, and deviations; ensures documents are in compliance; releases or rejects lots of raw materials, packaging components, imported bulk goods intended for production, and finished products intended for retail; issues appropriate certificates; assesses product returns
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