Position Summary:The Quality Control (QC) Senior Analyst - Raw Materials is a senior-level laboratory professional responsible for the testing, qualification, and release of raw materials used in the manufacturing of pharmaceutical products. This role ensures compliance with cGMP, regulatory requirements, and internal quality standards. The Senior Analyst also mentors junior analysts, leads investigations, and supports continuous improvement initiatives.
Key Responsibilities:- Perform complex analytical testing of raw materials (e.g., excipients, active ingredients, solvents) using techniques such as HPLC, GC, PSD, XRPD, Karl Fischer, and wet chemistry.
- Review and approve test data, ensuring accuracy, completeness, and compliance with SOPs and regulatory guidelines.
- Lead OOS (Out of Specification), OOT (Out of Trend), and Deviation investigations related to raw material testing.
- Author and revise SOPs, test methods, and validation protocols.
- Supports and executes method transfers, verifications, and validations.
- Collaborate with cross-functional teams including Quality Assurance, Manufacturing, and Supply Chain.
- Coordinate external testing with contract labs for raw materials (procuring quotes, purchase orders, shipping of samples, acquiring test results, etc.).
- Supports raw material qualification program.
- Train and mentor junior analysts and provide technical guidance.
- Participate in internal and external audits and inspections.
Qualifications:- Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field.
- Minimum 5 years of experience in a GMP-regulated QC laboratory, with a focus on raw material testing.
- Proficiency in analytical instrumentation (e.g., HPLC, GC, PSD, XRPD).
- Strong understanding of USP/NF, EP, JP, and other pharmacopeial standards.
- Familiarity with LIMS, Empower, and other laboratory software systems.
- Strong analytical thinking and problem-solving skills.
- Excellent written and verbal communication.
- Ability to work independently and as part of a team.
Preferred Qualifications:
- Experience with compendial testing and regulatory submissions.
- Knowledge of ICH, CFR guidelines and FDA/EMA expectations.
- Experience in clean lab or continuous improvement initiatives.
Work Environment:
- Laboratory setting with exposure to chemicals and analytical instruments.
- May require occasional lifting of lab equipment or materials up to 25 lbs.
- Use of PPE and adherence to safety protocols is mandatory.
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Salary Range
$95,000-$110,000 USD
