Senior Quality Control Analyst
5 days ago
The Senior Quality Control Analyst will oversee and perform analytical and microbiological testing of raw materials, in-process samples, and finished goods to ensure compliance with regulatory and internal quality standards. The role requires deep expertise in laboratory operations, regulatory compliance (FDA Philippines, BAI), and method validation. This position plays a key role in supporting product quality and safety at our San Mateo manufacturing site.
Key Responsibilities:
- Perform and supervise chemical, physical, and microbiological analyses on veterinary drug products and raw materials using instruments such as HPLC, GC, UV-Vis, and FTIR.
- Review and validate test results to ensure compliance with local (FDA Philippines, BAI) and international (cGMP, ASEAN, VICH) standards.
- Lead and document laboratory investigations, including Out-of-Specification (OOS) results, deviations, and non-conformances; support CAPA development and implementation.
- Maintain and troubleshoot laboratory equipment, ensuring timely calibration and preventive maintenance.
- Assist in the development and validation of analytical methods and SOPs.
- Provide technical support and mentoring to junior analysts, including training in Good Laboratory Practices (GLP) and safety procedures.
- Support audit readiness and actively participate in regulatory inspections and internal quality audits.
- Ensure all QC documentation adheres to Good Documentation Practices (GDP) and supports data integrity.
Qualifications:
- Bachelor's degree in Chemistry, Pharmacy, Biology, or a related field.
- Licensed Chemist or Registered Pharmacist preferred (PRC licensed).
- At least 2-3 years of experience in a QC laboratory setting, preferably in veterinary or human pharmaceutical manufacturing.
- Hands-on experience with analytical techniques (e.g., HPLC, GC, UV-Vis, titration).
- Strong knowledge of FDA Philippines, BAI, ASEAN, and cGMP requirements.
- Excellent attention to detail, problem-solving skills, and written documentation abilities.
- Experience leading or supporting laboratory investigations and audits.
Job Types: Full-time, Permanent
Pay: Php22, Php24,500.00 per month
Benefits:
- Additional leave
- Company Christmas gift
- Company events
- Free parking
- Health insurance
- Life insurance
- Opportunities for promotion
- Promotion to permanent employee
Work Location: In person
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