Quality Control Analyst
AppleOne Employment Services
As a Quality Control Analyst III, you’ll play a pivotal role in ensuring the safety, compliance, and quality of pharmaceutical products. This position offers the opportunity to work with advanced analytical techniques, cutting-edge equipment, and a team dedicated to excellence. This is a 6PM–6AM shift position, ideal for individuals with expertise in QC for APIs and finished dosages, and hands-on experience with GC and HPLC systems. Responsibilities:
- Conduct analytical testing for raw materials, in-process samples, final products, and stability samples using laboratory equipment such as balances, pipettes, pH meters, UV/Visible spectrophotometers, and TOC analyzers.
- Perform chromatography (Liquid/GC) after completing extensive qualification and training.
- Execute wet chemistry assays and water sample collection.
- Maintain and calibrate QC analytical instruments and general laboratory equipment.
- Prepare the laboratory for audits and ensure compliance with GMP standards.
- Assist in reviewing QC data, preparing summaries for management, and supporting investigations (OOS, deviations, CAPAs).
- Manage QC sample receipt, processing, shipment, and tracking for internal and external testing.
- Bachelor’s degree in Chemistry or a related field is required.
- Minimum of 5 years in pharmaceutical QC, specifically with APIs and finished dosages.
- Proficiency with GC and HPLC systems.
- Strong knowledge of FDA GMPs (21 CFR, 211, 820, and/or 600); ISO 9001 and 13485 knowledge is a plus.
- Advanced mathematical skills, including statistical analysis and sampling theory.
- Proficiency in Microsoft Office Suite and instrument manufacturer-based systems.
- Excellent verbal and written communication skills.
- Strong organizational and time management abilities.
- Ability to work independently under pressure and meet deadlines.
$63k - $79k
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