Quality Control Analyst - Second Shift
About The Position
The Quality Control Analyst conducts routine and non-routine analyses and reviews analytical data for raw materials, in-process samples, finished products, microbiology and cleaning validation programs, and other requested testing. Work is performed according to standard operating procedures and analytical methods, in accordance with current Good Manufacturing Practices (CGMP) and regulatory requirements. The analyst completes projects and testing with supervision, applies knowledge of Good Laboratory Practices, Good Documentation Practices, CGMP, and other regulatory requirements, and contributes to continuous improvement. The role requires judgment and appropriate escalation of issues to QC management and Quality Assurance. This is a full-time second-shift position with a Monday–Friday schedule from 2:30 p.m. to 11:00 p.m. Travel is not required. The listed full-time equivalent pay range is $34.00–$53.13 per hour, with eligibility for bonus, stock, and benefits.
Requirements
- Bachelor of Science degree in Chemistry or Biology.
- At least 1–2+ years of relevant experience in analytical chemistry or a related life sciences industry, or an equivalent combination of education, training, and experience.
- Knowledge of analytical equipment and instrumentation, including UV-Vis, Karl Fischer, HPLC/HPLC-MS, and pH.
- Ability to efficiently, accurately, and independently execute day-to-day tasks with minimal supervision.
- Knowledge of computer software and hardware applications, including Microsoft Word and Excel.
Nice To Haves
- Experience in CGMP, CDMO, and/or pharmaceutical settings.
- Familiarity with Agilent instrumentation and software.
- Knowledge of FDA and international regulations and guidelines, including USP, JP, EP, and ICH.
Responsibilities
- Provide direct support to manufacturing by testing and reporting data for in-process samples while meeting stringent schedules and deadlines.
- Conduct analyses associated with clinical and commercial products under CGMP regulations and guidance from the FDA and international regulators.
- Perform biochemical and/or chemical analyses on raw materials, in-process materials, active pharmaceutical ingredients, final products, and other requested samples according to established procedures.
- Collaborate and communicate directly with manufacturing, project managers, and QC management.
- Review data for compliance with specifications and report or escalate abnormalities as necessary.
- Follow Good Documentation Practices.
- Work cross-functionally to complete projects and testing.
- Support laboratory investigations and reports.
- Participate in routine laboratory and equipment maintenance.
- Perform special projects involving analytical and instrument problem solving and troubleshooting, as needed.
- Assist in mentoring or training others, as appropriate to knowledge and experience.
Benefits
- Eligibility for bonus.
- Stock.
- Benefits.
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What This Job Offers
Job Type
Full-time
