We are currently looking to fill a Quality Assurance Specialist position. This position performs activities supporting dispositioning product while ensuring compliance with Quality Assurance policies and procedures, cGMPs, SOPs, and Standard Requirement Documents.
Daily Responsibilities
- Represent Quality Assurance in support of complex and/or significant Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution
- Represent the organization on behalf of QA with external partners to communicate QA policy and procedures; liaise with external partners and provide input on regulatory communications
- Train and/or mentor employees, including providing insights and education on processes and procedures, and conveying expectations of QA organization
- Perform activities associated with disposition of raw materials and product (e.g. manufacturing record review, receipt, inspection, document review, shipping, etc). Activities may be on the floor or at a desk
- Review and approve investigations associated with raw materials, product, laboratory, or facilities
- Perform status labeling of raw materials and product
Skills & Qualifications
- Strong understanding of aseptic filling and/or packaging operations
- Strong organizational skills and attention to detail
- Ability to prioritize multiple assignments amid changing priorities
- Ability to learn and utilize computerized systems for daily performance of tasks
- Flexibility to work a varied schedule
- Willingness to travel up to 25% of the time
Education
To be considered for this role you must hold a Bachelor's degree and the following amount of relevant experience for each level:
- Associate QA Specialist - 2+ years
- QA Specialist - 4+ years
- QA Specialist - 6+ years
