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Specialist, III CAPA

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._

_Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus. The campus, featuring two manufacturing facilities is located 5 miles from the Baltimore Washington International (BWI) airport and 13 miles from our_ Baltimore location (https://biologics.catalent.com/our-locations/north-america/baltimore-usa/) _. The campus is close to Washington, DC’s I-270 Technology Corridor, top universities, and government agencies._

_The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10 CGMP manufacturing suites, fill/finish, central services, testing labs, and a warehouse._

_The Harmans/BWI-2 facility, at approximately 145,000 sq. ft., is under development and will house 8 CGMP manufacturing suites and cold storage warehousing._

_Both facilities support Phase 3 through commercial manufacturing of advanced therapeutic products including AAV and other viral vector-based therapies and vaccines._

Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent’s advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives.

The **CAPA Specialist III** is responsible for supporting the CAPA process by assisting in the initiation, tracking, trending, and documentation of CAPA activities. The position ensures that CAPA investigations, actions are properly managed, and follow-ups are conducted in a timely manner. The **CAPA Specialist III** will work closely with the CAPA Manager and cross-functional teams to drive effective corrective and preventive actions, ensuring that all CAPA-related tasks align with quality standards and regulatory requirements.

This is a full-time on-site position, M-F 8am-5pm

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:

+ Assist in the initiation, tracking, and documentation of CAPA activities, ensuring all CAPA investigations are properly documented and processed in a timely manner.

+ Support the CAPA Manager in coordinating and facilitating CAPA meetings, ensuring follow-up actions are taken and closure timelines are met.

+ Track and trend CAPA data to identify patterns and report trends to the CAPA Manager for further investigation or process improvement opportunities.

+ Collaborate with cross-functional teams, including Manufacturing, Quality Control, and Regulatory Affairs, to gather information and support the investigation of non-conformances, deviations, and customer complaints.

+ Prepare CAPA-related reports, including monthly, quarterly, and annual summaries, as well as specific reports for management and regulatory agencies.

+ Assist with the preparation of CAPA-related materials for internal audits, external audits, and regulatory inspections.

+ Ensure CAPA documentation is maintained in compliance with regulatory standards (e.g., FDA, ISO) and company policies.

+ Provide administrative support to the CAPA Manager, including organizing meetings, maintaining CAPA documentation, and communicating updates to stakeholders.

+ Support continuous improvement initiatives by suggesting process enhancements or efficiency improvements based on CAPA trends and data.

+ Assist in conducting training sessions for employees on CAPA procedures and best practices.

+ Maintain a thorough understanding of industry regulations, company policies, and CAPA procedures to ensure all activities are compliant with relevant standards.

The Candidate:

+ Masters’ degree in a Scientific, Engineering or Biotech field with 6 years’ experience in biopharmaceutical manufacturing processing in a GMP compliance environment (e.g. Production, Development, Process Engineering, Technical Services or related field)

OR

+ Bachelor’s degree in Scientific, Engineering or Biotech field with 8 years’ experience in biopharmaceutical manufacturing processing in a GMP compliance environment (e.g. Production, Development, Process Engineering, Technical Services or related field).

OR

+ Associate degree or HS Diploma with 8 -10 years’ experience in biopharmaceutical manufacturing processing in a GMP compliance environment (e.g. Production, Development, Process Engineering, Technical Services or related field)

+ Knowledge of CAPA, quality systems, and regulatory standards (FDA, ISO).

+ Detail-oriented with strong record-keeping and communication skills.

+ Collaborative team player with good organizational and multitasking abilities.

+ Proficient in Microsoft Office and adaptable to new software; possesses strong problem-solving skills.

_The anticipated salary range for this position in Maryland is $118,720-$163,240 plus annual bonus, when eligible. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states._

Position Benefits:

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

+ 152 hours of paid time off annually + 8 paid holidays

+ Competitive salary with yearly bonus potential

+ Community engagement and green initiatives

+ Generous 401K match and Paid Time Off accrual

+ Medical, dental and vision benefits effective day one of employment

+ Tuition Reimbursement

**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 (https://careers.catalent.com/us/en) 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 [email protected] . 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 [email protected] for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .