Quality Control Analyst III

Catalent Pharma Solutions • Chelsea, MA

6d • $90,000 - $110,000 • Onsite

About The Position

The Quality Control Analyst III supports product development, release, and stability testing at Catalent’s Chelsea, Massachusetts GMP facility. 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, ensures compliance with specifications, and helps revise and update standard operating procedures. The position is onsite Monday through Friday, 8:00 a.m. to 5:00 p.m.

Requirements

• Bachelor’s degree required, preferably in physical or chemical sciences (life sciences).
• Minimum of 4–6 years of experience in a cGMP-regulated environment.
• Chromatography skills using Empower required.
• Proficiency in Microsoft Office required.
• Ability to lift up to 20 lbs.
• Ability to stand for long periods of time.

Nice To Haves

• Experience in MDI/DPI analytical test methods, such as Andersen Cascade Impactor and Emitted Dose techniques.
• Experience with analytical method development and validation.

Responsibilities

• Operate analytical instrumentation, including HPLC, UPLC, GC, UV-vis, FTIR, laser diffraction, and KF.
• Statistically and critically analyze data for trending and reporting into regulatory filings.
• Participate in laboratory and/or quality investigations.
• Monitor equipment and instrumentation daily to ensure proper operation and calibration.
• Participate in the construction and/or revision of standard operating procedures.
• Assist in writing and updating analytical test procedures, protocols, log books, and checklists.
• Identify, alert, and propose solutions to issues involving instruments and/or test executions; lead and implement recommended solutions and/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 for career growth.
• Defined career path and annual performance review and feedback process.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior