Stability Program Coordinator

2 weeks ago

East Windsor Twp, United States Empower Pharmacy Full time
Company Overview

Empower is a pioneering healthcare organization dedicated to delivering high-quality, affordable medications to countless patients nationwide. We proudly stand as the largest 503A compounding pharmacy and FDA-registered 503B outsourcing facility in the country, catering to the functional medicine sector.

Our distinction lies in our unwavering commitment to three fundamental values: People, Quality, and Service. Our passionate team collaborates to innovate in manufacturing, distribution, and quality assurance, offering a uniquely integrated approach to healthcare. By leveraging our comprehensive pharmaceutical supply chain, cutting-edge technology, and a steadfast dedication to excellence, we continuously redefine medication accessibility and affordability.

When you join us, you are not merely starting a job; you are becoming part of a mission. We empower our team to innovate, grow, and effect meaningful change in the healthcare landscape. If you are a visionary who thrives in a dynamic, transformative environment, Empower is the ideal place for you. Here, you will be encouraged to share your insights, enhance your skills, and engage in projects that truly make a difference. We prioritize the well-being of our employees, offering a supportive and vibrant workplace where your contributions are acknowledged and celebrated.

Let’s transform healthcare together. Be part of something remarkable.

Position Summary

The Stability Coordinator plays a crucial role in supporting the stability program within Empower Pharma's 503B Outsourcing Facility. This position is responsible for coordinating stability studies and pulls, ensuring adherence to FDA and ICH guidelines, company quality standards, SOPs, and other regulatory requirements.

Duties and Responsibilities
  • Facilitates the initiation, execution, and completion of stability studies, including assisting in the design of stability protocols, scheduling, and conducting stability pulls, ensuring timely testing of stability samples.
  • Evaluates stability data to identify trends and potential concerns.
  • Compiles detailed stability reports and interim updates for ongoing studies, escalating any out-of-trend or unusual results to the Quality Unit for further investigation.
  • Collaborates 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.
  • Assists in overseeing quality systems relevant to stability studies, including managing deviations, CAPAs (Corrective and Preventive Actions), and change controls, ensuring compliance with cGMP (Current Good Manufacturing Practices) and GLP (Good Laboratory Practices).
  • Coordinates with external laboratories for the testing of stability samples as needed.
  • Manages the shipment and tracking of samples to ensure timely and accurate testing.
  • Maintains and oversees the stability sample inventory, ensuring precise record-keeping and tracking of all samples.
  • Contributes to the formulation development process, focusing on the stability aspects of new and existing products.
  • Participates in the creation and revision of SOPs (Standard Operating Procedures) related to stability studies.
  • Identifies and suggests process improvements to enhance efficiency and compliance.
  • Performs other duties as assigned.
To succeed in this role, an individual must effectively perform each essential function. The requirements listed above represent the knowledge, skills, and abilities required. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform essential functions.

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; experience with statistical software is advantageous.
  • Excellent written and verbal communication skills, essential for interacting with cross-functional teams and external partners.
  • Good understanding of laboratory equipment and testing methodologies.
  • Proficient in Microsoft Office products, with a strong emphasis on Excel.
  • Strong leadership capabilities with the ability to inspire and motivate a team.
  • Exceptional organizational and project management skills.
  • Strong interpersonal skills with the ability to collaborate and build relationships at all organizational levels.
  • Customer Focus: Ability to build strong customer relationships and deliver customer-centric solutions.
  • Optimizes Work Processes: Knowledge of the most effective and efficient processes to achieve objectives, with a focus on continuous improvement.
  • Collaborates: Builds partnerships and works collaboratively with others to meet shared goals.
  • Resourcefulness: Effectively secures and deploys resources.
  • Manages Complexity: Ability to navigate complex, high-quality, and sometimes contradictory information to solve problems effectively.
  • Ensures Accountability: Holds self and others accountable for meeting commitments and objectives.
Experience and Qualifications
  • A bachelor's degree in Biotechnology, Biology, Chemistry, or a related scientific discipline or equivalent experience is required.
  • A minimum of 1-3 years of experience in a pharmaceutical manufacturing environment is required, with a focus on quality control, stability studies, or related areas.
Employee Benefits, Health, and Wellness
  • No-Cost Medication: Access prescribed compounded medications at no cost.
  • Onsite Health & Wellness - IV Therapy Drips: Enjoy complimentary onsite IV Therapy drips to enhance well-being.
  • Comprehensive Medical, Dental, and Vision Options: Choose from three tailored medical plans, plus options for dental and vision coverage.
  • Telehealth Visits: Access board-certified doctors anytime, anywhere.
  • Paid & Volunteer Time Off: Benefit from paid time off for personal pursuits and volunteer opportunities.
  • Paid Holidays: Enjoy eight scheduled holidays and two floating holidays.
  • Life & AD&D Coverage: Financial protection for you and your family.
  • FSA (Flexible Spending Account): Manage healthcare expenses with pre-tax dollars.
  • 401K Dollar-for-Dollar Up to 3%: Invest in your future with a matching 401K plan.
  • Company Paid Long-Term Disability: Provided at no cost, replacing 60% of your income if disabled.
  • Flexible Schedules: Balance work and life with flexible scheduling options.
  • Rewards & Recognition Program: Enjoy recognition for your hard work beyond your paycheck.
Additional Voluntary Benefits
  • Accident Insurance: Provides a lump sum benefit for accidental injuries.
  • Hospital Indemnity Insurance: Supplemental insurance for unexpected hospital stays.
  • Critical Illness: Financial protection against serious health issues.
  • Short-Term Disability: Coverage for income protection during illness or injury.
  • Supplemental Life & AD&D: Additional financial protection for you and your loved ones.
  • Legal Services: Access to professional legal assistance.
  • Identity Theft Protection: Safeguard your identity and finances.
  • Pet Insurance: Coverage for your pets' health needs.
  • Employee Assistance Program: Confidential counseling and support services for overall well-being.

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