Quality Assurance Associate II
Fort Washington, PA
3rd Shift, Wednesday-Sunday
(2) days 8hr shift, (2) days 12hr shift
Every day, Kelly Science & Clinical connects professionals with opportunities to advance their careers. We are currently interviewing and hiring immediately for an experienced
Quality Assurance Associate II to join a global pharmaceutical, R&D, and medical device leader in
Fort Washington, PA.
The position is responsible for providing daily Quality Assurance support to the manufacturing site to ensure internal and regulatory cGMP and CFR requirements are met. Quality Assurance support areas include but are not limited to Batch Record Review, Product Release, Standard Operating Procedures, Investigations, CAPA, Change Control, Shop Floor Audits. The position will interact with other departments including Manufacturing, Packaging, Quality Laboratories, Quality Systems, Validation, Engineering, Maintenance, and other departments as it relates to site Quality Assurance responsibilities.
Provides daily ‘Shop Floor” QA support to warehouse, bulk manufacturing, and packaging lines.
Provides leadership support to QA Shop Floor activities including communication of quality events to management.
Performs or supports activities related to Batch Record Review, Raw Material, Bulk, and Finished Product Releases.
Provides support to Investigations and/or Investigation Protocols, responsibilities include conducting, writing, reviewing and approvals.
Performs or supports activities related Line Audits, Line or Area Cleaning Verifications
Participates in design of quality processes and creation/modification/approval of Standard Operating Procedures (SOP’s).
Provides support to Consumer Complaint investigations.
Provide QA support to various project teams, as needed.
Actively supports Site metrics, compliance improvement and training initiatives.
B.S. or B.A. College Degree (Science or Technical Degree preferred)
3-5years Pharmaceutical Industry Quality Experience, with proven success in quality systems/compliance improvement
Active cGMP Interpretation and Application Experience
Demonstrated leadership- possesses the ability to lead a team
Process and Systems Experience, especially with SOPs, MBRs, Change Controls, Non-Conformance Investigation Documentation
Experience with Liquid Dose processing and packaging technology preferred.
Validation Experience preferred
Expertise in Handling Multiple Priorities