QA Compliance Specialist
QA Compliance Specialist
The Quality Assurance department ensures that the site operates at a high level of compliance and ensures quality decisions are being made in accordance with Regulatory, corporate and site standards.
This position is responsible for the Quality Assurance Operational support, including batch record review, issuing batch records, Biopsy Accessioning Packages, label issuance and reconciliation, verification, and final product packaging and release to the courier.
- Support day to day operations, including: batch record issuance and review, label issuance, verification, archiving, and courier.
- Address and/or escalate compliance problems and issues.
- Support in maintaining and adhering to compliance requirements for established quality systems programs.
- Support completion of analysis, identify issues and provide recommendations for compliance improvements.
- Participate in determining objectives of significant mid-scale projects or assignments.
- May interact with project teams and applicable research groups as they impact the quality operation.
- Complete assignments with minimal supervision in a timely manner.
- Support compliance requirements and time frames.
- May interact with internal personnel on matters often requiring coordination between departments.
- Follow accurate oral and written procedures for review and release of intermediate and final product.
- Participate in internal audits to ensure compliance to cGMPs and Vericel requirements.
- Participate in internal walk-thru audits to ensure compliance to cGMP’s and Vericel requirements.
- Provide input to the technical composition of operating documentation.
- Other duties as assigned.
- Being honest and treating people with respect and courtesy.
- Bachelor’s degree or equivalent and 1+ years of related experience.
- Basic knowledge of GMP regulations.
- Strong written and verbal communication skills.
- Experience in utilizing Quality Management Systems e.g. Trackwise.
- Strong organization and time management skills.
- Proficient in MS Office suite.
- Experience in a biotech, pharmaceutical or other regulated industry.
Working Conditions and Physical Demands
- Ability to lift and transport up to 40 lbs.
- Availability to work 1 weekend day.
- Rotating holiday coverage.
All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity/Affirmative Action Employer.