**Position Summary**
The Quality Control (QC) Analyst will play a vital role in conducting analytical testing and data verification for both late-stage clinical and commercial small molecule and biosimilar products within cGMP-compliant laboratories. A robust background in protein chemistry is essential for effectively executing and troubleshooting methods such as HPLC, SDS-PAGE, cell-based bioassays, capillary electrophoresis, ELISA, and standard compendial assays. The ideal candidate will demonstrate a collaborative approach to resolving projects, conducting laboratory investigations, and implementing process improvements across multiple departments.
**Essential Duties & Responsibilities**
- Perform analytical testing to support in-process, release, raw materials, and stability programs for products.
- Maintain a strong understanding of cGMP regulations, Quality Systems, and ICH/regulatory guidelines.
- Conduct, compile, and review investigations related to Out of Specification results, deviations, and corrective and preventative action plans.
- Collaborate with cross-functional teams to advance projects, ensure equipment maintenance, and author documents and reports.
- Undertake additional responsibilities as assigned.
- Adhere to all company policies and standards.
- Analyze non-conformance incidents and conduct investigations as part of Quality Events, working closely with supervisors to resolve issues.
**Position Requirements and Qualifications**
**Education:**
- Bachelor’s degree in biotechnology, biochemistry, chemistry, or a related field with a minimum of 8 years of experience in a pharmaceutical/biotech QC laboratory. Alternatively, a Master’s degree in the aforementioned fields with 4-5 years of relevant experience.
**Experience:**
- Proven experience in a cGMP laboratory environment.
- Strong expertise in small molecule and protein chemistry, with a track record of troubleshooting analytical results.
- Successful history of writing, revising, and adhering to SOPs, policies, and QC methodologies.
**Specialized Knowledge and Skills:**
- Proficient in techniques such as HPLC, SDS-PAGE, cell-based bioassays, capillary electrophoresis, ELISA, and standard compendial assays.
- Experience supporting regulatory inspections (e.g., PAI).
- Familiarity with preparing regulatory dossiers and data packages for interactions with regulatory agencies.
**Work Environment & Physical Demands:**
**General Working Environment:**
- Combination of office tasks (reading, writing, reviewing, and editing documents) and significant time in the laboratory.
- Flexibility to work extended hours or weekends as needed.
**Noise:**
- Normal laboratory noise levels.
**Standing/Lifting:**
- Ability to lift up to 25 lbs.
**Visual:**
- Standard visual requirements.
**Stress:**
- Fast-paced environment focused on achieving ambitious project goals.
**Travel:**
- No travel required.
**Supervisory Responsibility:**
- None
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