Quality Assurance Specialist II, Operations - Nights

Quality Assurance Specialist II, Operations - Nights

Location:

Chelsea, MA (on-site). Night shift 7‑day rotating 12‑hour shift (hours 6 pm–6 am) following a 2‑2‑3‑2 schedule, often referred to as a Pitman schedule. Employees receive a 15% differential pay.

Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO). The Boston‑area facility is Catalent’s global Center of Excellence for spray‑dry dispersion and Dry Powder Inhaler (DPI) capsule manufacture and packaging. It houses inhaled powder spray‑drying lines and multiple commercial‑scale lines for capsule filling and blister packaging, featuring best‑in‑class GEA Niro SD1, SD4 and SD7 dryers – the largest CGMP unit of its kind for DPI in North America.

The Quality Assurance Specialist II supports daily operations in a GMP manufacturing facility with limited supervision, overseeing production activities, environmental monitoring, SOPs, batch records, and quality systems.

• Oversee production activities with limited supervision, including area clearance, issuance and review of batch records, and decision‑making on initiation of discrepancies.
• Review, approve, and support Materials Management and Supply Chain activities.
• Support the Environmental Monitoring Program for the Chelsea facility, including Controlled Environments and Clean Utilities.
• Revise and/or review and approve SOPs, Protocols, Reports, and Master Batch Records for continuous improvement; initiate discrepancies, including Deviations and Investigations, and support CAPA implementation.
• Review and approve Certificates of Analysis for Raw Materials, Intermediates, and Finished Goods; disposition of controlled materials (Work in Progress, Finished Product, and Raw Materials).
• Provide basic support during external compliance inspections and participate in shift change/floor meetings.
• Perform other duties as assigned.

• High School Diploma/GED required with at least five years of progressive experience in a GMP environment.
• Bachelor’s degree in a scientific discipline preferred with a minimum of three years of progressive experience in a GMP environment.
• Minimum of one year of Quality Assurance experience supporting GMP production.
• Working knowledge of GMPs and their application to pharmaceutical manufacturing; ability to interpret standards and make decisions with management support.
• Previous exposure to investigations and product complaints preferred.
• Proficiency in Microsoft Office Suite; experience with MRP or QMS preferred.
• Physical requirements:
  
  ability to sit, stand, walk regularly and occasionally lift up to 25 pounds.

Anticipated salary range for Massachusetts: $72,781 to $96,069 annually. Final salary offered will depend on experience, industry, skillset, and business needs. This range may not apply to positions outside Massachusetts.

• Defined career path and annual performance review and feedback process.
• Diverse, inclusive culture.
• Positive working environment focusing on continual process improvement.
• Potential for career growth within an expanding team dedicated to preserving and bettering lives.
• 152 work hours + 8 paid holidays.
• Multiple Employee Resource Groups focusing on D&I.
• Dynamic, fast‑paced work environment.
• Community engagement and green initiatives.
• Generous 401(k) match and company match on donations.
• Medical, dental, and vision benefits effective day one.
• Tuition Reimbursement program.
• Well Hub program promoting overall physical wellness.
• Perk Spot – exclusive discounts from over 900 merchants.

Join the global drug development and delivery leader and help us bring over 7,000 life‑saving and life‑enhancing products to patients worldwide. Catalent produces more than 70 billion doses per year, each benefiting someone’s life.

Personal initiative, dynamic pace, meaningful work.

Visit Catalent Careers to explore career opportunities.

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, please send an email to Disabili with the job number, title, and location. This request is reserved for individuals with a disability and will be processed by a U.S. Catalent employee and routed to a local recruiter.

Catalent never asks candidates to provide any type of payment, bank details, photocopies of identification, social security number, or other highly sensitive personal information during the offer process, and we never do so via email or social media. If you receive such a request,
DO NOT respond – it is a fraudulent request. Forward such requests to  for investigation.