Stability Coordinator

4 weeks ago

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

Empower is a visionary healthcare company committed to providing quality, affordable medication to millions of patients across the nation. We hold the distinguished position of being the largest 503A compounding pharmacy and FDA-registered 503B outsourcing facility in the country serving the functional medicine markets.

What sets us apart is our relentless focus on three core values: People, Quality and Service. Our dedicated team of professionals collaboratively works to break new ground in the fields of manufacturing, distribution and quality control, providing a uniquely integrated approach to healthcare. Leveraging our vertical integration of the pharmaceutical supply chain, state-of-the-art technology, and a commitment to excellence, we are constantly pushing the boundaries of what is possible in medication accessibility and affordability.

You're not just starting a job; you're joining a mission. We believe in empowering our team to innovate, grow, and drive real change in the healthcare industry. If you're a forward-thinker who thrives in a fast-paced, transformative environment, Empower is the place for you. Here, you'll be encouraged to share your ideas, expand your skill set, and contribute to projects that genuinely make a difference. We prioritize the well-being of our team members, and we offer a supportive and engaging workplace where your contributions are not just recognized but celebrated.

Let's revolutionize healthcare, together. Join us and be a part of something extraordinary.

Position Summary

The Stability Coordinator is responsible for supporting the stability program within Empower Pharma 503B Outsourcing Facility. This role will coordinate stability studies and stability pulls, and ensure compliance with FDA and ICH guidelines, company quality guidelines, SOPs, and other regulatory requirements.

Duties and Responsibilities

  • Supports the initiation, execution, and completion of stability studies including assisting with the design of stability protocols, scheduling, and conducting stability pulls, and ensuring that stability samples are tested within specified time frames
  • Analyzes stability data to identify trends and potential issues
  • Prepares comprehensive stability reports and interim updates for ongoing studies and escalates any out-of-trend or unusual results to the Quality Unit for further investigation
  • Works 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 to the oversight of quality systems relevant to stability studies, including handling deviations, CAPAs (Corrective and Preventive Actions), and change controls ensuring that all stability-related activities comply with cGMP (Current Good Manufacturing Practices) regulations and GLP (Good Laboratory Practices)
  • Liaises with external laboratories for the testing of stability samples when required
  • Manages the shipment and tracking of samples to ensure timely and accurate testing
  • Maintains and manages the stability sample inventory, ensuring accurate record-keeping and tracking of all samples
  • Assists in 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 recommends process improvements to enhance efficiency and compliance
  • Other duties as assigned
To perform this job successfully, an individual must be able to perform each essential function satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.

While performing the responsibilities of the job, the employee is required to speak and hear. The employee is often required to remain in a stationary position for a significant amount of the workday and frequently use their hands and fingers to handle or feel in order to access, input, and retrieve information from a computer and other office productivity devices. The employee is regularly required to move about the office and around the corporate campus. The employee is occasionally required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl. Vision abilities required by this job include close vision. The employee may occasionally be required to lift and move objects up to 25 lbs.

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 beneficial
  • Excellent written and oral communication abilities, necessary for interacting with crossfunctional teams and external partners
  • Good understanding of laboratory equipment and testing methods
  • Proficient in Microsoft office products, strong understanding of excel
  • Strong leadership skills 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 levels of the organization
  • Customer Focus: Ability to build strong customer relationships and deliver customer centric solutions
  • Optimizes Work Processes: Know the most effective and efficient processes to get things done, with a focus on continuous improvement
  • Collaborates: Builds partnerships and works collaboratively with others to meet shared objectives
  • Resourcefulness: Secures and deploys resources effectively and efficiently
  • Manages Complexity: Makes sense of complex, high quality, and sometimes contradictory information to effectively solve problems
  • Ensures Accountability: Holds self and others accountable to meet commitments and objectives
Experience and Qualifications
  • A bachelor's degree in Biotechnology, Biology, Chemistry, or a related scientific discipline is or equivalent experience, required
  • Minimum of 1-3 years' experience in a pharmaceutical manufacturing environment required, with a focus on quality control, stability studies, or related areas
Employee Benefits, Health, and Wellness
  • No-Cost Medication: Get your prescribed compounded medications at no cost, ensuring your health without the financial burden
  • Onsite Health & Wellness - IV Therapy Drips: Rejuvenate with complimentary onsite IV Therapy drips, enhancing your well-being and energy levels
  • Comprehensive Medical, Dental, and Vision Options: Choose from three medical plans tailored to your needs, plus options for dental and vision coverage for you and your family
  • Telehealth visits: Access board-certified Doctors anytime, anywhere for you and your family
  • Paid & Volunteer Time Off: Enjoy paid time off for personal pursuits and contribute to causes you care about with volunteer time off
  • Paid Holidays (8 scheduled; 2 floating): Celebrate with eight scheduled holidays and two floating holidays, giving you flexibility and time for personal traditions
  • Life & AD&D Coverage: Secure your and your family's financial future with life and accidental death and dismemberment (AD&D) insurance
  • FSA (Flexible Spending Account): Manage healthcare expenses smartly with pre-tax dollars in a Flexible Spending Account (FSA)
  • 401K Dollar-for-Dollar Up to 3%: Invest in your future with our 401K plan, featuring a dollar-for-dollar match up to 3%
  • Company Paid Long-Term Disability: Provided at no cost, which replaces 60% of your income if you become disabled for a long period of time
  • Flexible Schedules: Balance work and life seamlessly with our flexible scheduling options
  • Rewards & Recognition Program: Your hard work doesn't go unnoticed - enjoy rewards and recognition beyond your paycheck
Additional Voluntary Benefits
  • Accident Insurance: Pays a lump sum benefit to help cover expenses following an accidental injury
  • Hospital Indemnity Insurance: Enhance your peace of mind with supplemental hospital insurance for unexpected stays
  • Critical Illness: Protect your finances from the expenses of a serious health issue
  • Short-Term Disability: Protect your income during illness or injury with short-term disability coverage
  • Supplemental Life & AD&D: Add an extra layer of financial protection for you and your loved ones with supplemental life and AD&D coverage
  • Legal Services: Access professional legal assistance to address concerns confidently
  • Identity Theft Protection: Safeguard your identity and finances with our identity theft protection benefit
  • Pet Insurance: Care for your furry family members with our pet insurance coverage
  • Employee Assistance Program: Confidential counseling and support services for a holistic approach to your well-being

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