We are currently looking to fill a Quality Assurance Specialist position. This position performs activities supporting dispositioning product and/or raw materials while ensuring compliance with Quality Assurance policies and procedures, cGMPs, SOPs, and Standard Requirement Documents.
Daily Responsibilities
- Representing Quality Assurance in support of sophisticated Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution
- Participate as a QA representative on Technology Transfer Startup Teams where responsibilities include providing guidance on QA procedures and policies as well as review of documents for both internal and external transfers
- Providing consultation or advice in alignment with QA policies
- Reviewing completed records and batch sheets and working with other departments and communicate internally and externally effectively
- Performing activities associated with disposition of product (e.g. document review, shipping), activities may be on the floor or at a desk
- Reviewing, editing, or approving controlled documents
- Performing status labeling of product
- Continually evaluating processes and procedures with an eye toward continuous improvement
Desirable Skills
- Excel in a quality driven organization
- Have an understanding of biologics manufacturing operations
- Are organized and have an attention to detail
- Can prioritize multiple assignments and changing priorities
- Are able to learn and utilize computerized systems for daily performance of tasks
Education
To be considered for this role you must hold a Bachelor's degree and the following amount of relevant experience for each level:
- QA Associate - 0-2+ years
- Associate QA Specialist - 2+ years
- QA Specialist - 4+ years
- QA Specialist - 6+ years