Quality Assurance Specialist II

Work Schedule: 2/2/3 – 6:00 PM to 6:00 AM. 100% on-site. Position Summary The Chelsea facility is Catalent’s global Center of Excellence for spray dry dispersion and Dry Powder Inhaler (DPI) capsule manufacture and packaging. It features advanced spray drying equipment and multiple commercial‑scale lines for capsule filling and blister packaging, including GEA Niro SD1, SD4, and SD7 dryers. The Role Oversight, with limited supervision, of production activities including area clearance, issuance and review of batch records, and decisions on initiation of discrepancies. Oversight, review, and approval of Materials Management and Supply Chain activities. Support of the Environmental Monitoring Program for controlled environments and clean utilities. Revision, review, and approval of SOPs, protocols, reports, and master batch records for continuous improvement. Support of CAPA implementation as determined through discrepancies. Review and approval of certificates of analysis for raw materials, intermediates, and finished goods. Disposition of controlled materials (work in progress, finished product, and raw materials). Other duties as assigned. The Candidate Bachelor’s degree in a scientific discipline (required). Minimum of 3–5 years of progressive experience in a GMP environment (required). Minimum of 1 year of quality assurance experience supporting GMP production (required). Working knowledge of GMPs and their application to pharmaceutical manufacturing (required). Experience with Material Requirements Planning (MRP) systems (preferred). Ability to lift up to 50 lbs. Pay The anticipated salary range for this role in Massachusetts is $72,781 to $96,069 annually. The final salary offered to a successful candidate may vary based on experience, skill set, education, and business needs. Benefits Defined career path and annual performance review and feedback process. Diverse, inclusive culture. Potential for career growth within an expanding team dedicated to improving lives. 152 hours of PTO + 8 paid holidays. Generous 401(k) match. Medical, dental, and vision benefits. Tuition reimbursement program. Equal Employment Opportunity Statement 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 email, confirming your request for accommodation and including the job number, title, and location to View email address on click.appcast.io. #J-18808-Ljbffr Catalent