Pharmacist in Charge 503B - East Windsor, NJ

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.  

The Pharmacist in Charge (PIC) plays a crucial role at Empower Pharmacy, serving as the cornerstone of our commitment to delivering safe, high-quality, and innovative medications. This position is vital in ensuring that our operations align with FDA regulations, state and federal laws, and USP standards. The PIC is not only responsible for maintaining rigorous compliance but also for leading cross-functional teams to develop and implement comprehensive Standard Operating Procedures (SOPs) that ensure our facility meets the highest standards of regulatory compliance and quality.

As the PIC, you will lead the preparation for regulatory inspections and audits, ensuring that all processes, from environmental monitoring to sterility testing, are meticulously documented and adhered to. Your expertise will be essential in overseeing the entire compounding process, from raw materials to final product, ensuring that every medication we produce meets stringent quality specifications. By conducting routine walkthroughs and floor-level observations, you will maintain a hands-on approach to quality assurance, continuously identifying areas for improvement and driving process enhancements.

Your role also extends to being a clinical expert, responsible for reviewing and investigating customer complaints and adverse drug events, ensuring that any issues are resolved promptly and reported to the FDA as required. Additionally, you will collaborate with healthcare providers and institutions to understand their needs and ensure customer satisfaction throughout the customer lifecycle. Your leadership in maintaining proper inventory, implementing robust documentation practices, and ensuring the safety of the work environment will be critical to the ongoing success and reputation of Empower Pharmacy.

Join Empower Pharmacy and lead a team dedicated to producing innovative medications that help people live healthier, happier lives. If you are passionate about quality, regulatory compliance, and customer satisfaction, and eager to contribute to a company that values service and innovation, we invite you to apply. Help us expand access to quality, affordable medication and make a meaningful impact on the health and well-being of our patients and communities.

• Ensures the facility operates in full compliance with FDA regulations, state, and federal laws, and relevant USP standards.
• Leads cross-functional teams to develop comprehensive SOPs and implements to maintain regulatory compliance.
• Leads preparation for regulatory inspections and audits by regulatory agencies.
• Establishes compliance within the quality assurance program, including environmental monitoring, sterility testing, and validation processes through the creation and management of an internal audit program.
• Ensures all compounded medications meet rigorous quality standards and specifications by continuous monitoring and evaluation of raw materials, production processes, and final products. This includes routine floor-level walkthroughs to directly observe compounding operations.
• Conducts thorough investigations and implements effective resolutions of any quality-related issues or deviations. Continuously identifies areas for improvement and implements process enhancements to streamline shipping operations.
• Continuously identifies areas for improvement and oversees process enhancements to ensure compliance with ongoing regulatory changes.
• Clinical expert for review and investigation of customer complaints and adverse drug events including ensuring complaints are reported to the FDA per regulatory requirements.
• Ensures proper inventory of raw materials according to established procedures, including proper storage and handling.
• Identifies and mitigates potential risks associated with sterile compounding operations by continuously evaluating the compounding process.
• Implements and maintains robust documentation practices to ensure accuracy and compliance.
• Serve as clinical expert for the Training Department in the development and execution of training programs related to regulatory compliance ensuring all safety protocols are strictly followed to maintain a safe working environment.
• Collaborates with healthcare providers and institutions throughout the customer lifecycle to understand their needs and ensure customer satisfaction.
• Ensures any customer inquiries or concerns regarding compounded medications are addressed and resolved.
• Performs other duties as assigned.

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.

• In-depth knowledge of compounding regulations, current good manufacturing practice and state pharmacy laws.
• Strong leadership and communication skills.
• Proficient in Microsoft Office Skills-Excel, Word, PowerPoint, Outlook.
• Required experience with injectables (mixing, vial washing, dehydrogenation tunnels or ovens, fill-finish).
• Industry experience with the following preferred:
  • Non-sterile operations and terminal sterilization of finished goods. 
  • 503B Outsourcing Facility.
  • Sterile finished product forms – IV bags, syringes, vials, pellets, etc.
  • Contract Development and Manufacturing Organization.
  • 21 Code of Federal Regulations experience required: European Union Annex 1 preferred.
• Must be able to enter the cleanroom and manufacturing space (maintain gown qualification) as needed for audits and escalations.

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.

• Minimum of 5 years of experience in sterile compounding, demonstrating expertise in aseptic techniques, regulatory compliance, and quality assurance within a sterile pharmacy environment.
• Minimum of 2 years of experience in a supervisory or managerial role.
• Preferred Certification in sterile compounding (e.g., Board Certification in Sterile Compounding).
• Preferred Certified Quality Auditor (or other similar certification).
• Active Pharmacist License in applicable state.
• Other State Pharmacist Licenses as required.

• 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.