What are the responsibilities and job description for the Quality Control (QC) Chemist position at TPPTECH CDMO?
Quality Control (QC) Chemist
Company: TPPTECH (tpptech.com)
Location: San Diego, CA
Role Summary
Serve as a key member of the Quality Control team supporting commercial-scale production of liquid and lyophilized (freeze‑dried) drug products. Ensure all raw materials, in‑process samples, and finished goods meet stringent quality, purity, and regulatory specifications. Leverage analytical chemistry expertise—and foundational microbiology skills—to maintain cGMP compliance and drive continuous improvement in testing workflows.
Key Responsibilities
- Analytical Testing & Method Execution: Perform routine and non‑routine assays (HPLC, GC, UV/Vis, titrations) on raw materials, in‑process samples, and final drug products (liquid & lyophilized). Develop, validate, and troubleshoot analytical methods under cGMP guidelines.
- Sample Management & Documentation: Receive, log, and track all QC samples; ensure chain‑of‑custody integrity. Accurately record data, calculate results, and release or reject batches per SOPs and specifications.
- Microbiological Screening (Preferred): Conduct basic microbial limit tests and sterility checks; assist microbiology lab staff as needed.
- Compliance & Quality Systems: Write and review SOPs, test protocols, and deviation reports. Lead investigations of out‑of‑specification results and support CAPA implementation. Participate in internal and external audits; support regulatory submissions.
- Continuous Improvement & Training: Identify opportunities to streamline QC workflows, reduce variability, and improve data quality. Mentor junior QC associates; deliver on‑the‑job training for new analytical techniques.
Required Qualifications
- Bachelor’s degree in Chemistry, Pharmaceutical Sciences, or related field.
- Minimum 5 years of hands‑on experience in QC analytical chemistry within a cGMP pharmaceutical environment.
- Proficiency with HPLC, GC, UV/Vis spectroscopy, differential scanning calorimetry (DSC), Karl Fischer titration, or equivalent techniques.
- Strong record‑keeping, data integrity, and problem‑solving skills.
- Excellent communication and collaboration across cross‑functional teams (Manufacturing, QA, Regulatory).
Preferred
- Some coursework or practical exposure in microbiology: microbial limit testing, sterility assays, bioburden control.
- Experience with lyophilization processes, formulation characterization, and stability testing.
- Familiarity with LIMS and electronic batch records.
Core Competencies
- Attention to Detail: Rigorous approach to testing and documentation.
- Analytical Mindset: Ability to interpret complex data and drive root‑cause investigations.
- Regulatory Acumen: Deep understanding of cGMP, 21 CFR Part 211, and ICH guidelines.
- Team Player: Collaborates effectively, mentors others, and embraces continuous learning.
Pay: $70,000.00 - $90,000.00 per year
Work Location: In person
Salary : $70,000 - $90,000