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Stability Coordinator

2 months ago

South Bend, Indiana, United States Tri Pac, Inc. Full time
Job Description:

This is a new position to add to our growing team at Tri-Pac, Inc., a leading contract development and manufacturing company (CDMO) specializing in liquid and aerosol filling for personal care and pharmaceutical marketers.

Key Responsibilities:
  • Coordinate and support the site stability program, formulation, and stability sampling activities in compliance with the FDA ICH guidelines, company quality guidelines, SOP's and other regulatory requirements.
  • Work well with cross-functional teams and be the key point of contact for all stability programs for OTC, Medical device, and Cosmetic products.
  • Initiate stability studies, coordinate stability pulls, ensure the testing schedule of stability samples is met, analyze stability data, evaluate trends, and write stability reports.
  • Author stability protocols, interim reports, and reports for stability studies, including routine campaign stability studies and non-routine project stability studies.
  • Report the trending of stability data through data management and trend analysis using appropriate software.
  • Evaluate and escalate any trends to the R&D Manager and support any investigations based on the test data collected.
  • Support the business in requests relating to stability data, including temperature excursion assessments, regulatory requests, and investigational work.
  • Own and support stability-related Deviations, CAPAs, and Change Controls, and progress department improvements.
  • Manage stability studies following internal procedures, ensuring studies are set up per the protocol.
  • Interact with other groups in R&D and other departments, such as QC and production, as required.
  • Collaborate with relevant QC laboratories to ensure stability samples are tested within their specified time frame for actives and micro.
  • Coordinate the shipment of stability samples to outside labs when required.
  • Maintain stability trackers for routine annual stability and lab stabilities.
  • Have good knowledge of lab equipment and testing methods, including viscosity, pH, specific gravity, and API's.
  • Have knowledge of cGMP regulations and GLP.
  • Support R&D lab with formulation development for OTC, Cosmetic, and Medical device products in different forms, including aerosol, liquid, and BOV.
  • Improve current product formulations.
  • Lead formulation development activities with a focus on stability as the primary responsibility.
  • Be proficient in Microsoft Office 365.
Requirements:
  • Associate or bachelor's degree in a scientific discipline, and 2 or more years of related experience and/or training, or an equivalent combination of education and experience.
  • Demonstrate knowledge of common analytical tools and techniques.
  • Have previous experience with conducting stability studies and knowledge of statistics.
  • Have previous experience in a GMP environment.
Benefits:

Competitive salary and benefits package, including vacations, insurance, 401K, life insurance, disability (long-term and short-term), and continuous training.

Tri-Pac, Inc. recognizes the importance of continuing education and offers education assistance to our employees to encourage continued personal development and growth.