What are the responsibilities and job description for the Quality Assurance Specialist position at Planet Pharma?
8 month contract
PR 45-49.33/hr commensurate with experience
Thousand Oaks, CA or Remote
This role supports the Quality Disposition and Distribution of the company's clinical and commercial bulk Labeled Drug Product (LDP) and Final Drug Product (FDP) to global regions and ensures compliance to Good Manufacturing and Good Distribution Practices. This includes performing Batch Record Review, disposition of LDP and FDP, supporting cold chain distribution, providing quality oversight to technical transfer activities related to labeling and packaging operations, and process improvements at CMO’s (Contract Manufacturing Organization). This position interacts cross-functionally with all areas of Quality, Supply Chain, Clinical Operations, and Regulatory Affairs.
- Performs Batch Record Review and Release of LDP and FDP at the CMO.
- Provides quality documents to Regulatory Affairs and Clinical Operations to support Single-Patient-Use (SPU) distribution.
- Partners with the Qualified Person on Batch Record Review and Release of LDP and FDP.
- Support technical transfer activities and ensure compliance of labeling, packaging, and distribution operations at CMO.
- Support quality aspects related to cold chain distribution.
- Serves as quality contact and support major nonconformance investigations, CAPA implementation and change control, document revision, and product complaints related activities.
- Provides routine Quality Assurance & Compliance support, and assess the upcoming regulations impacting the compliance activities of labeling, packaging, and distribution activities
- Drafts and approves related controlled documents such as SOPs, Work Instructions, and Forms
- Optimizes the batch packaging and distribution process and workflow, drives continuous improvements in the areas of labeling, packaging, and distribution
- Support New Product Introduction (NPI), evaluates and assures that the new or revised process that includes the product labeling, packaging & distribution are compliant with the current regulations & meeting the product specifications
- Supports IND, CTA preparation, and Audit readiness initiatives
Qualifications:
- Bachelor’s Degree in Engineering or Life Sciences.
- 5 years of related Pharmaceutical or Biotech industry experience in GMP regulated Biologics or Pharmaceutical environment
- Experience in a commercial phase pharmaceutical environment
- Experience with Contract Manufacturing Organizations (CMOs)
- Advanced knowledge of relevant regulations and regulatory guidance required to act as a resource for colleagues
- Root Cause Analysis
- Ability to effectively plan, organize work activities and prioritize task completion to meet deadlines
- Strong knowledge in 21 CFR 210/211, 21 CFR 1271, and 10 CFR 810, Eudralex volume 4, and ATMPs preferred
- Flexibility in working schedule (may occasionally require off hours and weekend work)
- Demonstrate ability to work in a team environment to develop, implement and deliver on goals
- Demonstrate ability to work successfully and with an appropriate sense of urgency in a nimble fast paced matrixed environment
- Ability to work both independently without supervision and be a part of a team, demonstrating excellent communication and interpersonal skills
- Strong problem solving and analytical skills with demonstrated ability to be detail-oriented; while managing multiple projects simultaneously
- Strong team player and ability to collaborate cross-functionally
- Role model for TRAIT values (Transparency, Respect, Accountability, Integrity, Trust)
