Quality Control Analyst III

Catalent; Burlington (MA); On-site; USD 90,000 - 110,000; Full time

Benefits offered by this job

Medical, dental, and vision benefits (

Tuition reimbursement

Competitive paid time off + 8 paidhol

Job summary

Catalent’s Chelsea, Massachusetts site is seeking a Quality Control Analyst III to support product development, release, and stability testing. You will perform chemical and physical analyses of raw materials, in-process materials, and drug products, compile data for documentation, participate in investigations, and help revise procedures.

The role requires a Bachelor's degree in physical or chemical sciences, 4–6 years in a cGMP environment, and proficiency with Empower; on-site at our Chelsea,

Qualifications

• Bachelor’s Degree in Physical or Chemical Sciences (life sciences).
• 4–6 years of experience in a cGMP regulated environment.
• Chromatography using Empower.
• Proficiency in Microsoft Office.

Responsibilities

• 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.

Skills

Chromatography (Empower)

Microsoft Office

Education

Bachelor’s Degree in Physical or Chemical Sciences

Tools

Empower

Job description

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.

Position 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

Work Type

100% Onsite

The Role

• 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

The Candidate

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

Preferred Skills & Background

• 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

Pay

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 time off plus 8 paid holidays.
• Community engagement and green initiatives.
• Medical, dental, and vision benefits effective day one of employment.
• Tuition reimbursement.

Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to [e-mail]. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

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Volunteer Work Disclosure

Applicants for employment in Massachusetts may include in their employment history any verified work performed on a volunteer basis.

Massachusetts Lie Detector Test Notice

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law may be subject to criminal penalties and civil liability. Consistent with Massachusetts law, Catalent does not require or administer lie detector tests as a condition of employment or continued employment.