Batch Record Reviewer

Batch Record Reviewer

Position Summary

• Shift: Monday-Friday 6am-2:30pm or 8am-4:30pm
• 100% on-site

The Research Triangle Park (RTP) facility is home to Catalent's Inhalation franchise including product development, clinical and commercial manufacturing for pMDI, DPI and Nasal Sprays.  

Catalent Pharma Solutions is Morrisville, NC is hiring a Batch Record Reviewer. Documentation in the Manufacturing Batch Records represents the Intermediate and Final Products manufactured by Catalent and must accurately and precisely represent the work done during production. The Batch Record Reviewer is responsible for executing the review and successful release of all batch records used in Catalent manufacturing. The reviewer works cross-functionally with Quality Assurance personnel to meet goals identified by Catalent leadership to facilitate the approval and release of Catalent products.

The role:

• Execute batch record review for completeness, accuracy and cGMP compliance
• Review documentation for manufacturing activities associated with commercial, development, and engineering execution in accordance with good documentation practices (GDP), including but not limited to: executed batch records, master batch records, product labels, SMPs, and product specific documents
• Utilize QA and Manufacturing personnel and data resources to make corrections to batch record entries such that they are fully compliant with cGDP guidelines.
• Perform duties under limited supervision and according to standard operating and manufacturing procedures
• Understand risks and delays to batch release and communicate appropriately
• Maintain reporting elements (metrics) for individual Quality and Quantity of daily assignments

The candidate:

• Bachelor’s degree (Life Science preferred) with 2 years of experience executing, reviewing, and/or writing SOPs and Batch Records in a GMP industry (biologics preferred)
• Associate’s degree or HS Diploma with 4 years of experience executing, reviewing, and/or writing SOPs and Batch Records in a GMP industry (biologics preferred)
• Demonstrated success in the documentation of GMP processes
• Familiarity with Good Manufacturing Practices (GMPs), 21 CFR 210/211/600s, USP and ICH Guidelines
• Have the knowledge and ability to apply basic scientific and regulatory principles to solve operational tasks

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 [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.