Quality Control Analyst III

Catalent•Chelsea, MA

4d•Onsite

About The Position

Catalent’s Chelsea, Massachusetts site is a global Center of Excellence for spray dry dispersion and dry powder inhaler capsule manufacturing and packaging. The approximately 96,000-square-foot GMP facility provides services including powder processing, capsule filling, blister packaging, and on-site quality control and analytical testing. The Quality Control Analyst III supports product development, release, and stability testing. The role performs chemical and physical analyses of raw materials, in-process materials, and drug products according to standard operating procedures; compiles data for documentation; participates in investigations and reports; ensures compliance with specifications; and contributes to revising and updating procedures. The position is Monday through Friday, 8:00 a.m. to 5:00 p.m., and is 100% onsite in Chelsea, Massachusetts.

Requirements

Bachelor’s degree, preferably in physical or chemical sciences (life sciences).
At least 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.

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 in accordance with standard operating procedures.
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 constructing and revising standard operating procedures.
Assist in writing and updating analytical test procedures, protocols, log books, and checklists.
Identify, alert others to, and propose solutions for instrument or test-execution issues; 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.
Compile data for documentation, participate in investigations and reports, and ensure compliance with specifications.
Perform other duties as assigned.