Quality Records Specialist
3 days ago
We are seeking a highly skilled Quality Records Specialist to join our team at Innova Solutions. As a Quality Records Specialist, you will play a critical role in ensuring the accuracy and completeness of quality records, facilitating timely release of products, and collaborating with cross-functional teams to drive quality excellence.
Key Responsibilities:- Process external deviation and change records from Contract Test Laboratories (CTLs)
- Coordinate testing of samples for lot release, PPQ, PSQ, and compile vendor documentation to generate CoA/CoT
- Partner with Global Product Quality, External Manufacturing Supply Chain, and Global Supplier Quality to release vector in a timely manner for commercial, clinical, and early development programs
- Initiate, facilitate, and track quality records
- Provide regular communication and metrics for status of quality records
- Effectively communicate issues, risks, and proposed solutions within the organization
- Provide communication, support, and guidance to CTLs within the QA vector and upstream material team
- Create and revise SOPs, CoAs, and CoTs
- Enter data and retrieve information from SharePoint and Smartsheet testing trackers
- Preferred Bachelor's degree in a relevant scientific discipline or 3 years' experience in biotherapeutics/biomanufacturing QC/QA
- Experience with deviation and change control management, preferably with Infinity systems
- Advanced project management skills, including process excellence/six sigma methods and approaches
- Experience within the Cellular Therapeutics and/or gene-based products, with biologics considered
- Knowledge of applicable FDA/EMA regulations in the biotechnology industry
- Experience managing external suppliers and other supply chain issues
- Experience with Quality Systems (change control, deviation, and investigation)
- Competitive pay rate: $30 - $31 per hour
- Benefits package, including medical, dental, vision, 401(k), HSA, FSA, life insurance, pet insurance, short-term and long-term disability, accident and critical illness coverage, pre-paid legal and ID theft protection, sick time, and paid leaves
- Opportunity to work with a global company with a strong presence in the industry
Innova Solutions is a leading provider of technology and business transformation solutions, with a global presence and a reputation for excellence. We are committed to delivering high-quality services and solutions to our clients, and we are seeking talented individuals to join our team.
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