Supervisor, Quality Systems 503B - East Windsor, Nj

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 As Supervisor of Quality Systems, you ensure document control and regulatory compliance, aligning with internal and Food and Drug Administration (FDA) standards. By leading your team and supporting audits, you directly contribute to Empower's mission of expanding access to affordable, quality medication and improving lives.

Duties and Responsibilities Leads the Document Control team, ensuring accuracy and compliance with internal and FDA standards.Oversees documentation preparation for audits, ensuring records are audit ready.Reviews controlled documents, resolves discrepancies, and updates them for clarity and compliance.Manages product profiles, including stability reports and reviews, to ensure audit readiness.Stays informed about evolving regulatory guidelines, proactively implementing necessary updates to internal procedures to maintain compliance.While performing the responsibilities of the job, the employee is required to talk 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 the computer and other office productivity devices. The employee is regularly required to move about the office and around the corporate campus. The employee is regularly required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl. This role may involve working in lab or manufacturing settings with exposure to hazardous materials, requiring the use of personal protective equipment.

Knowledge and Skills Strong knowledge of FDA regulations, current Good Manufacturing Practices, and other industry standards.Excellent organizational and time-management skills, with an elevated level of attention to detail.Proficiency in document management software and Microsoft Office applications.Key Competencies 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.Situational Adaptability: Adapts approach and demeanor in real time to match shifting demands of different situations.Communicates Effectively: Develops and delivers multi-mode communications that convey a clear understanding of the unique needs of different audiences.Values People: Our people define who we are as a company, and we believe that understanding and addressing the needs of our team, clients, and community is fundamental to fostering a culture of support and growth.Quality: Quality stands at the core of our mission, reflecting our commitment to excellence in every medication we produce.Service: We are here to serve others. Every interaction with our patients, providers, employees and other stakeholders comes from a place of service.Innovation: By continuously exploring new methodologies and embracing technology, we ensure that every solution we offer is at the forefront of pharmaceutical care. Experience and Qualifications Minimum of 5 years of experience in a document control role within a pharmaceutical manufacturing environment or equivalent experience required.Bachelor's degree in a relevant field or equivalent work experience, required. 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 4%: Invest in your future with our 401K plan, featuring a dollar-for-dollar match up to 4%.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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