Compliance Quality Assurance Job Description
Compliance quality assurance
provides professional expertise and strong leadership in applicable guidance and regulations, proactively identifying potential areas of non-compliance and risk for assigned areas.
Compliance Quality Assurance Duties & Responsibilities
To write an effective compliance quality assurance job description, begin by listing detailed duties, responsibilities and expectations. We have included compliance quality assurance job description templates that you can modify and use.
Sample responsibilities for this position include:
Ensure product compliance with J&J Worldwide Standard Procedures (WWSPs), U.S. and Global Quality Systems Regulations (QSRs) including 21 CFR 210, 21 CFR 211, 21 CFR Part 11, and 21 CFR 820 and current Good Manufacturing Practices (cGMPs)
Lead, develop and implement new policies, standards and guidance for new technologies, new businesses and emerging regulations
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
Demonstrate understanding of 21 CFR Part II, 210, 211 and equivalent global regulations
Experience in either a legal, compliance or regulatory background, preferably within the Financial Services Industry
Review and approve the Development Plan (DP) for new products and product changes requiring an APR or Global Change Control (GCC) to ensure that all work has been conducted according to the DP, established procedures and regulatory requirements
Evaluate emerging trends and regulations and develop communication and implementation plans for new requirements
Identify and investigate gaps in process, policy, procedures and First Line of Defense (FLOD) controls
Update and maintain testing procedures
Support completion of analysis, identify issues and provide recommendations for compliance process improvements
Compliance Quality Assurance Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Compliance Quality Assurance
List any licenses or certifications required by the position: HACCP, ASQ, ACAMS, PCQI, CQA, CQE, SQF, CFE, CAMS, RAPS
Education for Compliance Quality Assurance
Typically a job would require a certain level of education.
Employers hiring for the compliance quality assurance job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Collage Degree in Science, Finance, Education, Engineering, Business, Chemistry, Economics, Criminal Justice, Biology, Forensic Accounting
Skills for Compliance Quality Assurance
Desired skills for compliance quality assurance include:
Regulations
Financial services
Applicable laws
Risk/Compliance/Audit competencies
Regulatory trends that impact their assigned line of business
U.S. Bancorp operations
Policies
Procedures
Customer service delivery systems
USA PATRIOT Act
Desired experience for compliance quality assurance includes:
Participate in determining objectives of significant mid-scale projects or assignments
Support compliance requirements and time frames
Effectively demonstrate an understanding of cGMP's and how they apply to specific responsibilities
Support day to day operations of quality assurance group, including batch record issuance and review, label issuance, verification, archiving and courier dispatch
Participate in internal audits to ensure compliance of operating documentation
Some prior knowledge of Compliance would be advantageous
Compliance Quality Assurance Examples
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Compliance Quality Assurance Job Description
Job Description Example
Our innovative and growing company is looking to fill the role of compliance quality assurance. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for compliance quality assurance
- Implement and deploy enhancements to current quality system policies and procedures
- Compiles and reviews raw data, batch records and 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
- Ensure the compliance of Ionis’ manufacturing and testing activities with respect to Ionis procedures, FDA, EU, ICH, and other regulatory guidelines
- Compiles and reviews laboratory data or manufacturing batch records in accordance to cGxP and internal procedures in an efficient and timely manner
- Oversees the development and implementation of standardized policies, processes, and technology to ensure facilities, manufacturing, packaging, and shipping practices comply with requirements
- A good understanding of Anti Money Laundering (AML)
- Experience of the Know Your Customer/Client (KYC) Process within a customer screening environment
- Experience within a Client On-boarding environment
- Knowledge of Politically Exposed Persons (PEP’s) and Sanction issues
- The ability to show initiative and react quickly to changes in priorities
Qualifications for compliance quality assurance
- A minimum of 3 years of in-depth experience in a front-line environment
- Strong cross business product knowledge
- Technically strong in the following programmes – Excel, Powerpoint
- Technically strong in the following programs – Excel, PowerPoint
- Able to build strong, open dialogue-based relationships with relevant Stakeholders
- Action oriented with a strong focus on completing tasks accurately and efficiently whilst working independently and with minimum direction
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Compliance Quality Assurance Job Description
Job Description Example
Our innovative and growing company is hiring for a compliance quality assurance. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for compliance quality assurance
- Experience within a Client On-boarding environment (beneficial)
- Develops reports to track and report the activities related to business line implementation of action items and CAS and regulatory findings
- Works closely with the testing managers to ensure timely and accurate reporting of testing results on a weekly, monthly, and quarterly basis for senior management
- Partner with their assigned Lines of Business, other Risk/Compliance/Audit (RCA) Consultants, and RCA Managers to, depending on their function, create, implement, maintain, review or oversee an effective risk management framework
- Work with CQA design team to build/update the testing program
- Perform periodic reviews of credit card business lines to assess adherence to Regulation Z
- Organize and maintain accurate work papers, documenting testing results
- Testing of Business Change Risk Assessments (BCRA) other Targeted Tests as needed
- Ensure a constant state of inspection readiness and that all audit observations are addressed
- Review and Close incident investigations including final product disposition decision
Qualifications for compliance quality assurance
- A 4 year university or college degree
- Maintain knowledge of bankruptcy rules and consumer banking products
- 3+ years of experience in a cGMP production facility
- Provide input and guidance to the team conducting the investigation
- Make recommendations to department management regarding results of investigation and process improvements
- Minimum of 2 years in a Quality Assurance role that includes final closure review of deviation/non-conformance investigations and batch disposition determination
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Compliance Quality Assurance Job Description
Job Description Example
Our innovative and growing company is looking to fill the role of compliance quality assurance. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for compliance quality assurance
- Develop solutions to a variety of complex problems related to deviations, investigations, or any other quality events related to manufacturing and testing operations
- Oversee quality programs including raw material release, intermediate and lot disposition, stability data review
- Implement, oversee, and execute Ionis’ Vendor Qualification program
- Manage and oversee the environmental monitoring and water testing programs, including training of sampling personnel, qualifying required contract testing laboratories, and ensuring compliance of the programs with USP, EP, and ISO guidelines
- Prepare technical reports related to quality operations, especially as related to manufacturing operations and microbiological control of the facility
- Review technical reports supporting establishment of critical process parameters and their associated acceptable ranges
- Ensure the facility and operation are maintained in a state of inspection readiness
- Act as a lead and subject matter expert during regulatory authority inspections
- Manage partner inspections and partner commitments as required per relevant Quality Agreements
- Provide oversight for process, cleaning, and method validation activities
Qualifications for compliance quality assurance
- 2+ years of related experience at a Pharmaceutical, Biotech, or Medical Device company
- Significant Quality Assurance experience and expertise in a contact center environment
- Bachelor degree or 3+ years of relevant work experience in statistics, quality control, project management
- Scientific, Laboratory, and/or Production experience required
- Possess strong written and verbal communication skills to deal with various levels of management and employees internally vendors/factories
- 4-year degree in business, managed care, marketing, or similar applicable discipline
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Compliance Quality Assurance Job Description
Job Description Example
Our company is looking for a compliance quality assurance. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for compliance quality assurance
- Serves as the company’s primary contact and strategist for regulatory bodies (FDA, DEA and state Boards of Pharmacy)
- Develops and manages capital and operating budgets
- Manages a Regulatory and Quality staff of nearly 200 associates in five locations
- Reviewing Corrective Action closure documentation and identifying gaps and inconsistencies with the documentation which arise during the closure of Corrective Actions
- Clearly and concisely reporting gaps to project owners and other key stakeholders
- Identifying any potential gaps which might be a sign of under remediation or that customer harm has not ceased
- Working with project owners to resolve all open items in a timely manner
- Providing feedback and guidance to support the closure of gaps identified in the review
- Supporting efforts to inform Compliance and Bank management of emerging trends
- Executing ad hoc requests and projects as needed
Qualifications for compliance quality assurance
- Experience in Design for Product Regulatory compliance is a plus
- Minimum of 3 to 5 years of Medicare experience required
- Proven ability to manage and build a team
- Proven ability to proactively mitigate compliance risk and be an agent of change
- Ability to comprehend and clearly articulate information to a variety of audiences
- Excellent interpersonal and listening skills with a positive attitude and an openness to learning and helping to effectuate
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Compliance Quality Assurance Job Description
Job Description Example
Our innovative and growing company is looking to fill the role of compliance quality assurance. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for compliance quality assurance
- To ensure that Quality Assurance and compliance requirements are part of a project’s overall executions strategy and deliverables
- Contribute to the development, review and approval of project technical transfer plans
- Provide an independent Quality assurance review of GMP relevant project and operational documents
- Facilitate internal and global change controls to support the projects as required
- Participate in Quality Risk Assessments and manage the quality risk strategy
- Establish a framework with relevant Manufacturing Authorisation Holders to ensure product Quality review processes and two way data and information exchange
- Actively review internal and external audit findings through similar projects and establish appropriate mitigations at BMW
- Contribute to internal Quality audits and pre-approval inspections and post approval inspections
- To be a primary contact point for corresponding Quality groups and project expansion groups across the CSL network
- To build and retain knowledge within the Quality Assurance function and sustain compliance to stabilise and strengthen our new and existing businesses
Qualifications for compliance quality assurance
- Knowledge of database development tools
- This position requires a Bachelor’s Degree in a relevant discipline (e.g., chemistry, biological sciences, engineering, ) with at least 10 years of experience in the pharmaceutical industry and at least 8 years of Quality Assurance experience in a current Good Manufacturing Practices (cGMP) environment
- This individual will have and maintain proficiency in FDA, EU and ICH regulatory requirements and guidelines related to cGMP operations
- Excellent problem solving skills, based on science, facts, data and understanding of the regulatory requirements in complex and evolving environments
- Excellent interpersonal/communication skills, interpersonal agility and self-awareness
- Proven ability to work with other team members and constituents to gain credibility