Quality Assurance Document Control

Senior Quality Assurance Document Control

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.

Catalent Pharma Solutions is hiring a Senior Quality Assurance Document Control. The Senior Quality Assurance Document Control coordinates the team and activities associated with batch record documentation, reviewing and approving batch records, and releasing batch records and finished product.  The position requires the individual to prepare customer files, review and approve batch records, and release batch records and finished product.  The position requires communication between the operations/production, project management, shipping and quality assurance groups to ascertain pertinent information relating to the contract packaging orders.  Provides schedules to the Operations and Project Management teams regarding batch record reviews and customer responses. Also responsible for participating in special projects and/or tasks and ensuring that all functions are being performed in compliance with SOPs.

The Quality Assurance department is responsible for ensuring compliance with the quality system and product quality requirements defined by international regulations and corporate, network, and local standard operating procedures.  The Quality Operations department supports this by providing oversight and guidance on matters affecting the quality system or product quality in daily operations.

This is a full-time role position: Monday-Friday 8:00am-5:00pm. Onsite

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  

• Responsible for ensuring batch record documentation aligns with activities performed and is compliant against Catalent procedures. Responsibility for releasing supplies for distribution. Manage workload against the schedule for production priorities, working closely with the Scheduling and Production
• Publish daily batch record status report. Act as the Quality partner to support packaging operations and ensure projects are on-track. Enforce Catalent policy & regulatory requirements
• Sets priorities for the team to ensure task completion; coordinates work activities with QADC. Investigate Events / Deviations regarding batch record documentation and support investigations led by Operations. Interact with customers regarding questions, issues, metrics, batch records, etc.
• Track and report metrics. Respond to and investigate customer complaints. Support activities related to the TrackWise System. Assist with customer and government audits. Review & revise SOPs, batch records, Change Orders and other related documentation
• Audit for compliance as pertains to Catalent SOPs, regulatory, & customer requirements. Support Corporate and local Quality policies and initiatives
• Anticipates internal and or external business challenges and/or regulatory issues; recommends process, product or service improvements. Review of completed batch record for conformance with protocol and appropriate cGMP and ensure that any changes are performed according to procedures
• Confirm proper randomization schedule utilization for correct patient treatment group assignment. Communicate with other functions to resolve inconsistencies with proper recording and completion of the batch record and associated documentation; communications may include educating other functions to ensure compliance to regulations, procedures and client requirements
• Archive batch documents onto shared drive and within archive room. Complies with and ensures compliance with EH&S, and 5S requirements for QADC
• All other duties as assigned; 

The Candidate 

• Required a High School Diploma with three years relevant industry experience required
• Bachelors Degree highly preferred
• Previous cGMP experience is required
• At least two years of experience working in a pharmaceutical or medical device environment is strongly preferred; Two years of experience in QADC is strongly preferred
• Experience working with packaging batch records review and approval, release of products, packaging, labeling, assembley and distribution of clinical trial materials is preferred
• At least 2 years of experience with JDE is preferred
• Individual may be required to sit, stand, walk regularly and occasionally lift up to 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 of PTO 8 paid holidays
• Several Employee Resource Groups focusing on D&I
• Dynamic, fast-paced work environment
• Community engagement and green initiatives 
• Generous 401K match 
• Medical, dental and vision benefits effective
• 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.