Job Title: Quality Assurance Specialist III
Duration: 12 months (possible extension)
Location: Mettawa, IL 60045
Working hours: M-F, 8-4:30 (hours can be flexed)
Description:
- The role supports two key areas in clinical operations:
- Drug Product Pipeline - Focuses on manufacturing tablets and oral fill solutions for clinical trials.
- Finishing Plant - Takes large batches of drug products (e.g., drums of tablets), bottles them (e.g., 50 tablets per bottle), and distributes them.
- Engages cross-functionally to investigate and document compliance events, ensuring timely resolution to enable program timelines.
- Works with Databases and electronic systems.
- Follows through with business partners to receive investigation results, actions planned, and closure of actions by requesting and reviewing objective evidence.
- Collects relevant monthly and quarterly metrics.
- Involves quality assurance oversight, ensuring compliance with GMP and investigating deviations (e.g., tablet defects, labeling issues, or procedural violations).
- Project management responsibilities include tracking investigations, setting up communication (emails, follow-ups), and ensuring quality tasks are completed on time.
- We use TrackWise for quality management (transitioning to OneTrack next year). Experience with either system is preferred.
- Cross-functional collaboration with PhDs, chemists, engineers, manufacturing personnel, and quality teams-requires strong communication and negotiation skills.
- Investigations require knowledge of timing requirements, root cause analysis, and GMP principles. The specialist ensures investigations are completed but does not lead them.
Must-Have Skills:
- GMP experience with a strong understanding of compliance principles.
- Scientific background to support investigations and documentation.
What we are looking for:
- Bachelor's degree in a scientific field is required. A master's degree (especially in a scientific discipline) can be helpful,
- Experience: Minimum 2 years required, 4+ years preferred in pharmaceutical quality assurance, compliance, or CAPA investigations.
- Experience with inventory tracking systems (SAP or other similar systems) is beneficial for managing quality records.
- Pharmaceutical or highly regulated industry experience is required. (Medical device experience is acceptable for this role.
- Previous experience in CAPA, Lean Six Sigma, Quality Assurance, and program management.
- Demonstrated experience in technical writing, managing program timelines, and leading diverse teams.
- GMP (Good Manufacturing Practices) compliance is a critical requirement for this role.
- Writing sample is required - Must demonstrate an understanding of GMP principles and CAPA processes. Candidates must provide a writing sample to demonstrate their understanding of GMP principles and CAPA processes (AI-generated writing samples will be rejected-the hiring manager wants to assess the candidate's actual writing and comprehension skills.)
- Project management experience is a must-have - formal certification is not required, but candidates must have experience managing projects or initiatives.
- Experience with TrackWise or OneTrack (quality management systems) is beneficial. Familiarity with SAP or other inventory tracking systems is also needed.
Skills:
- Must be an Effective Communicator. Strong technical writing skills; Clear, concise and effective in written communication; Self-starter, takes initiative and owns the task, Organized.
- Ability to lead a diverse team and drive results.
- Adept at learning and utilizing multiple electronic systems. Proficient in MS Office Suites.
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Spectraforce Technologies
Apr 04, 2025