Quality Assurance Specialist - Full-time / Part-time

***Must have 5+ years of manufacturing experience in Biologics. Targeting validation exp., non-conformance, CAPA, Change Control and Tackwise experience.***

***This person will primarily be working 1st shift. Must be willing to work 2nd shift depending on operation needs.***

Ideal Candidate:
Previous experience in QA, Validation, or compliance areas, 75% on the floor / ~25% at the desk (doc review), pass gowning certification, pass visual test to perform AQL, flexible to work different shift and managing multiple priorities at the same time.

Job Details:
Responsible for all quality oversight functions related large molecule Bulk Drug Substances (BDS), Drug Products (DP), and Finished Products (FP) manufactured .
Primary responsibilities of this position include:
- Responsible for providing Quality oversight to ensure that products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP) and other applicable regulations
- Ensures that facilities, equipment, materials, processes, procedures and products comply with cGMP practices and other applicable regulations
- Responsible for ensuring raw materials and components, bulk drug substances, bulk drug products, and finished product for assigned areas meet GMP requirements
- Ensures the Quality unit provides review, approval and tracking of cGMP processes, procedures, assays, documents and records, including non-conformances, CAPAs, change control records and validations.
- Ensures that changes that could potentially impact product quality are assessed according to procedures
- Ensures that deviations from established procedures are immediately triaged, investigated and documented per procedures
- Ensures that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements
- Ensures that GMP functions are periodically audited to assess compliance to cGMP regulations and to identify potential risks
- Alerts senior management of significant quality, compliance, supply and safety risks
- Perform AQL for Visual Inspection (must have successful passing results visual test before)
- Release of gases, cell banks and labels
- Oversight the Aseptic Processing filling and provide advice and guidance during the process

Previous experience in QA, Validation, or compliance areas, 75% on the floor / ~25% at the desk (doc review), pass gowning certification, pass visual test to perform AQL, flexible to work different shift and managing multiple priorities at the same time.

About Aerotek:

We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.

Aerotek is acting as an Employment Agency in relation to this vacancy.