Quality Assurance Specialist II

Quality Assurance Specialist II, Operations

Position Summary :

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

The Boston-area facility is Catalent's global Center of Excellence for spray dry dispersion and Dry Powder Inhaler (DPI) capsule manufacture and packaging. The site features inhaled powder spray drying, as well as multiple commercial-scale lines for capsule filling and blister packaging. On-site spray dryers include best-in-class GEA Niro SD1, SD4 and SD7, the latter being the largest CGMP unit of its kind for DPI in North America.

Catalent Pharma Solutions is hiring a Quality Assurance (QA) Specialist II. The Quality Assurance Specialist II is responsible for supporting daily operations in a GMP (Good Manufacturing Practices) Manufacturing Facility. This individual provides oversight of production activities with limited supervision.

This is a full-time on-site salaried role : This position has a 7-day rotating 12-hour shift with hours between 6am-6pm, although overtime may be required depending on production needs. This shift is a 2-2-3-2 schedule, often referred to Pitman schedule.

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.

The Role :

Oversight (with limited supervision) of production activities, including area clearance, issuance and review of batch records, and making decisions on initiation of discrepancies

Oversight (with limited supervision), review, and approval of Materials Management and Supply Chain activities

Support of Environmental Monitoring Program for Chelsea Facility, including Controlled Environments and Clean Utilities

Revision and / or review and approval of SOPs, Protocols, Reports, and Master Batch Records for continuous improvement. Initiation of Discrepancies, including Deviations and Investigations. Support of implementation of CAPA 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)

Provide basic support during compliance inspections conducted by external sources (i.e. health authorities). Support GMP manufacturing shifts as needed, including participation in shift change / floor meetings with the operators

All other duties as assigned

The Candidate :

High School Diploma / GED is required with at least five (5) years of progressive experience in a GMP environment

Bachelor's degree in a scientific discipline is preferred with a minimum of three (3) years of progressive experience in a GMP environment

Minimum of one (1) year of Quality Assurance experience in support of GMP production required

Working knowledge of GMPs and their application to pharmaceutical manufacturing is required. Must be able to interpret applicable standards and objectively make decisions with the support of management

Previous exposure to investigations and product complaints preferred

Must be proficient in Microsoft Office Suite, and experience with Material Requirements Planning (MRP) systems or Quality Management Systems (QMS) is preferred

Physical requirements : Individual may be required to sit, stand, walk regularly and occasionally lift up to 25 pounds

Why you should join Catalent :

Defined career path and annual performance review and feedback process

Diverse, inclusive culture

Positive working environment focusing on continually improving processes to remain innovative

Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives

152 Hours + 8 paid holidays

Several Employee Resource Groups focusing on D&I

Dynamic, fast-paced work environment

Community engagement and green initiatives

Generous 401K match

Company match on donations to organizations

Medical, dental and vision benefits effective day one of employment

Tuition Reimbursement - Let us help you finish your degree or start a new degree!

WellHub program to promote overall physical wellness

Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. 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.

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, 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 DisabilityAccommodations@catalent.com . 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.

Notice to Agency and Search Firm Representatives : Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and / or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and / or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers :

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 any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE () .