Quality Control Analyst III
About The Position
The Quality Control Analyst III supports product development, release, and stability testing at Catalent’s Chelsea, Massachusetts site. The role performs chemical and physical analyses of raw materials, in-process materials, and drug products in accordance with standard operating procedures, compiles data for documentation, participates in investigations and reports, and ensures compliance with specifications. The analyst also contributes to revising and updating standard operating procedures and analytical testing documentation. The position operates analytical instruments, critically analyzes data for trending and regulatory reporting, monitors equipment performance and calibration, and identifies and resolves instrument or testing issues. The analyst independently organizes workflows, provides guidance and support to colleagues, and helps implement policies, programs, and corrective actions. The position is 100% onsite, Monday through Friday, 8:00 a.m. to 5:00 p.m., in Chelsea, Massachusetts.
Requirements
- Bachelor’s degree, preferably in physical or chemical sciences or life sciences.
- A minimum of 4–6 years of experience in a cGMP-regulated environment.
- Chromatography skills using Empower.
- Proficiency in Microsoft Office.
- Ability to lift up to 20 pounds.
- Ability to stand for long periods of time.
Nice To Haves
- Experience with MDI/DPI analytical test methods, such as Andersen Cascade Impactor and Emitted Dose techniques.
- Experience with analytical method development and validation.
Responsibilities
- Perform chemical and physical analyses of raw materials, in-process materials, and drug products according to standard operating procedures.
- Operate analytical instruments, including HPLC, UPLC, GC, UV-vis, FTIR, laser diffraction, and KF equipment.
- Statistically and critically analyze data for trending and reporting into regulatory filings.
- Participate in laboratory and/or quality investigations and related reports.
- Monitor equipment and instrumentation daily to ensure proper operation and calibration.
- Participate in constructing and revising standard operating procedures.
- Assist in writing and updating analytical test procedures, protocols, log books, and checklists.
- Identify, report, and propose solutions to instrument or test execution issues; lead and implement recommended solutions or corrective actions.
- Independently organize workflows to accomplish objectives.
- Provide guidance and support to colleagues and promote new policies and programs effectively.
- Perform other duties as assigned.
Benefits
- Competitive paid time off and 8 paid holidays.
- Medical, dental, and vision benefits effective on the first day of employment.
- Tuition reimbursement.
- Potential bonus.
- Defined career path and annual performance review and feedback process.
- Career growth opportunities.
- Community engagement and green initiatives.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
