Quality Control Analyst III
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Quality Assurance - QA/QC
Quality Control - QC Analysts/Managers, Quality Engineering, Regulatory Compliance Specialist, QA Specialist - Analyst/Manager
Job Description & How to Apply Below
Quality Control Analyst III. Catalent’s Chelsea, Massachusetts site — often referred to as the Boston location is a global Center of Excellence for spray dry dispersion (SDD) and dry powder inhaler (DPI) capsule manufacturing and packaging, supporting inhalation drug products from clinical development through commercial launch. Located at 190 Everett Avenue, the approximately 96,000‑square‑foot GMP facility features ISO 8 production suites, high‑potency containment capabilities, and advanced spray drying equipment, including multiple large‑scale GMP spray dryers.
The site offers integrated services such as powder processing, capsule filling, blister packaging, and on‑site quality control and analytical testing, with capacity to produce up to 100 million capsules annually. Strategically positioned just minutes from Boston Logan International Airport and within the Greater Boston life sciences hub, the Chelsea site plays a critical role in Catalent’s global inhalation network and regulatory‑compliant manufacturing operations.
Summary
We have an opportunity for a Quality Control Analyst III to join our team supporting product development, release, and stability testing. This role involves performing chemical and physical analyses of raw materials, in‑process materials, and drug products following standard operating procedures. The position includes compiling data for documentation, participating in investigations and reports, and ensuring compliance with specifications. The Quality Control Analyst also contributes to revising and updating standard operating procedures as needed.
Shift: Monday - Friday, 8:00am to 5:00pm
Location:
Chelsea, MA 100% Onsite
- 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;
- 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 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
- Other duties may be assigned
Minimum Requirements
- Bachelor’s Degree is required, preferably in Physical or Chemical Sciences (life sciences)
- Minimum of 4–6 years of experience in a cGMP regulated environment is required
- Chromatography skills using Empower is required
- Proficiency in Microsoft Office is required
- Ability to lift up to 20 lbs. is required
- Ability to stand for long periods of time is required
- 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
The anticipated salary range for this position in MA is $90,000 – $110,000 plus bonus. The final salary offered to a successful candidate may vary and will depend on factors such as experience, skillset, education, and business needs. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.
Why You Should Join Catalent- Defined career path and annual performance review and feedback process.
- Diverse, inclusive culture.
- Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
- Competitive paid…
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