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Pharmaceutical Stability Specialist

2 months ago

East Windsor Twp, United States Empower Pharmacy Full time
Job Summary

The Stability Coordinator is a critical role within Empower Pharmacy's 503B Outsourcing Facility, responsible for ensuring compliance with FDA and ICH guidelines, company quality guidelines, SOPs, and other regulatory requirements.

Key Responsibilities
  • Coordinate stability studies and stability pulls, including designing stability protocols, scheduling, and conducting stability pulls.
  • Analyze stability data to identify trends and potential issues, and prepare comprehensive stability reports and interim updates for ongoing studies.
  • Escalate any out-of-trend or unusual results to the Quality Unit for further investigation, and work closely with departments such as R&D, Quality Control, Quality Assurance, and Production to align stability study requirements with overall product development and manufacturing processes.
  • Oversee quality systems relevant to stability studies, including handling deviations, CAPAs, and change controls, and liaise with external laboratories for the testing of stability samples when required.
  • Manage the shipment and tracking of samples to ensure timely and accurate testing, and maintain and manage the stability sample inventory, ensuring accurate record-keeping and tracking of all samples.
  • Assist in the formulation development process, focusing on the stability aspects of new and existing products, and participate in the creation and revision of SOPs related to stability studies.
  • Identify and recommend process improvements to enhance efficiency and compliance, and ensure that all stability-related activities are conducted in accordance with company policies and procedures.
Requirements
  • A Bachelor's Degree in Biotechnology, Biology, Chemistry, or a related scientific discipline is required.
  • Minimum of 1-3 years' experience in a pharmaceutical manufacturing environment is required, with a focus on quality control, stability studies, or related areas.
Knowledge and Skills
  • Familiarity with ICH guidelines, FDA regulations, and other relevant regulatory requirements for stability testing.
  • Proficiency in analyzing complex data sets and reporting on stability study outcomes, and experience with statistical software is beneficial.
  • Excellent written and oral communication abilities, necessary for interacting with cross-functional teams and external partners, and good understanding of laboratory equipment and testing methods.
  • Proficient in Microsoft office products, strong understanding of Excel, and strong leadership skills with the ability to inspire and motivate a team.
  • Exceptional organizational and project management skills, and strong interpersonal skills with the ability to collaborate and build relationships at all levels of the organization.
Benefits
  • Comprehensive medical, dental, and vision options.
  • Telehealth visits with board-certified doctors.
  • Paid and volunteer time off.
  • Paid holidays and floating holidays.
  • Life and AD&D coverage.
  • FSA (Flexible Spending Account) for healthcare expenses.
  • 401K dollar-for-dollar match up to 4%.
  • Company-paid long-term disability.
  • Flexible scheduling options.
  • Rewards and recognition program.
Additional Voluntary Benefits
  • Accident insurance.
  • Hospital indemnity insurance.
  • Critical illness insurance.
  • Short-term disability insurance.
  • Supplemental life and AD&D insurance.
  • Legal services.
  • Identity theft protection.
  • Pet insurance.
  • Employee assistance program.