Document Control Specialist, Quality Assurance

Document Control Specialist – Quality Assurance

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 QA Document Control Specialist who is responsible for the management and organization of Good Manufacturing Practice (GMP) documents. The Document Control Specialist will support the site’s document lifecycle including client approvals and archiving. This position requires strong technical strong organizational skills and attention to detail to manage document workflows and version control across various internal departments.

This is a full time, salaried role. This position is fully onsite, no hybrid or remote work. The core hours are Monday – Friday – days 8:00AM – 4:30PM

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

• Facilitates the life cycle of master documents (including but not limited to SOPs, Batch Records, Test Methods, Protocols, Reports, Specifications, Logbooks, etc.) by functioning as a document workflow coordinator. Tasks may include the issuance, digitization, obtaining internal and client approvals, reconciliation and archiving of above documents and support document Periodic Reviews;
• Reviews master documents according to approved procedures and templates, maintains document properties (metadata), monitors document status and approval notifications, distributions, and archiving;
• Provides day-to-day support of the electronic document management system (EDMS), and operational controls to maintain the validated state (compliance with 21 CFR Part 11);
• Collaborates with team to identify opportunities for process improvement in the Document Control program and works cross functionally to implement, as appropriate;
• May assist with end-user training for new users of the EDMS and document control business processes.
• Participates in Standard Operating Procedures generation and review;
• All other duties as assigned

The Candidate

• Associates Degree or equivalent required; Bachelor’s degree preferred.
• Minimum of 0 years of relevant work experience in the regulated Biotechnology or Pharmaceutical industries or relevant comparable background highly preferred;
• Experience with Electronic Document Management (EDMS: Documentum ) and Learning Management Systems (LMS: ComplianeWire) preferred;
• Familiar with applicable regulatory requirements (e.g., 21 CFR Parts 11, 210, 211, 820);
• Must be proficient in MS Office Suite. Excellent oral and written communication skills;
• Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 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.