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Catalent

Global contract drug formulation, manufacturing, packaging

Quality Control Analyst 3

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeChelsea, MA, USA

About the Job

Requirements

  • A bachelor's degree is required, preferably in Physical or Chemical Sciences (life sciences).
  • A minimum of 4–6 years of experience in a cGMP-regulated environment is required.
  • Chromatography skills using Empower are required.
  • Proficiency in Microsoft Office is required.
  • Ability to lift up to 20 pounds is required.
  • Ability to stand for long periods of time is required.

Responsibilities

  • Perform chemical and physical analyses of raw materials, in-process materials, and drug products in accordance with standard operating procedures.
  • Compile data for documentation, participate in investigations and reports, and ensure compliance with specifications.
  • Revise and update standard operating procedures as needed.
  • Operate analytical instrumentation such as HPLC, UPLC, GC, UV-vis, FTIR, laser diffraction, and KF.
  • Statistically and critically analyze data for trending and reporting into regulatory filings, and 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, and assist in writing and updating analytical test procedures, protocols, log books, and checklists.
  • Identify, alert, and propose solutions to issues on 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.

Desired Qualifications

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

About the Company

Catalent

Global contract drug formulation, manufacturing, packaging

Catalent provides end-to-end contract development and manufacturing services for pharmaceutical, biotechnology, and consumer health products. Its offerings cover drug formulation, large-scale manufacturing, clinical supply, and packaging under long-term partnerships, coordinating through a connected supply chain to move products from development to market. It differentiates itself with a broad, integrated service platform and long-standing customer relationships that help clients accelerate development and ensure reliable supply. The company aims to help clients bring products to market efficiently while balancing quality, cost, and sustainability across the product lifecycle.

Company size
5,001-10,000
Company stage
IPO
Headquarters
Franklin Township, NJ
Founded
1996

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