Stability Coordinator
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.
St. Petersburg is our primary softgel development and manufacturing facility in North America with a capacity of 18 billion capsules per year. The featured RP Scherer softgel technology is a proven oral drug delivery solution to enhance bioavailability of poorly soluble Rx and OTC drug candidates. Non-gelatin based OptiShell® and Vegicaps® capsules expand the range of molecules into softgel, ideal for challenging fill formulation. Within the Catalent network, we offer a broad range of integrated formulation.
The Stability Coordinator is responsible for generating stability protocols, initiating stability storage, Supports the review of Quality agreements and ensures stability program requirements as directed in the QAA are met as necessary. The Stability Coordinator is secondary support to the Associate Stability Coordinator when required to identify and retrieve samples as required per the stability schedule and documents the receipt of samples for analysis into the laboratory. Ensures all related documents are fully and accurately completed in accordance with SOP, and ICH guidelines. Comply with divisional and site Environmental Health and Safety requirements.
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. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.
The Role
Ensures the adherence to the standards of quality ruled by the current Good Manufacturing Practices and the Company’s Quality Policies. Complies with local and global policies and procedures to oversee and maintain the site stability program.
Ensures compliance with cGMPs and departmental procedures by promptly reporting non-compliance issues to management.
Proposes and assist in the implementation of quality improvements to stability program. Effectively compile and interpret data and identify the impact of deviations to product quality and stability program in collaboration with subject matter experts.
Supports investigations and follow corrective and preventive actions instituted. Ensure results reported in support of the site stability program are valid, accurate, and documented per applicable regulatory requirements. Enters new studies into the computerized stability management system in accordance with applicable SOPs.
Assists in investigation and impact assessment of temperature/humidity excursions and/or OOS and OOT stability results.
Ensure stability samples are retrieved and stored according to approved protocols. Own, develop and generate stability protocols to define storage conditions and pull stations for stability studies.
Maintain inventory and coordinates final destruction and performs reconciliation of stability inventory upon completion of stability studies. Perform accurate labeling of stability samples when necessary.
Generate stability summary reports as required. Perform documentation peer reviews. Perform sample transfer requests as required. Prepare samples for shipment and complete the required documentation. Perform pull schedule revisions as required. Monitor stability supplies and order as needed. Support review and ensure compliance to QAA stability requirements.
Other duties assigned.
The Candidate
Bachelors’ degree in a related science required.
3+ years’ experience with documentation systems required.
Solid understanding of cGMPs as they apply to documentation and QMS required.
Pharmaceutical experience is preferred.
LIMS experience for data entry and sample tracking is preferred.
Sample handling experience (pull, log, enter in database, create labels, etc.) is preferred.
Vision requirements include ability to differentiate color (Pass the Ishihara Color Vision Screening) and obtain 20/30 acuity in both far and near vision with or without corrective lenses. For Catalent’s in-house screening, the acceptable score is to identify at least 4 of 6 numbers in the circles.
Why you should join Catalent:
Tuition Reimbursement – Let us help you finish your degree or earn a new one!
WellHub program to promote overall physical wellness.
152 hours of PTO + 8 paid holidays.
Medical, dental and vision benefits effective day one of employment.
Defined career path and annual performance review and feedback process.
Diverse, inclusive culture. Several Employee Resource Groups focusing on D&I. Community engagement and green initiatives.
Dynamic, fast-paced work environment.
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.
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.