Pharmacist 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

The role of the 503B Pharmacist is pivotal to ensuring Empower Pharmacy operates at the highest standards of regulatory adherence, quality, and operational excellence. This position embodies our core values of people, service, quality, and innovation, serving as a key player for maintaining compliance with Food and Drug Administration (FDA) regulations, state and federal laws, and relevant United States Pharmacopeia (USP) standards. By developing and implementing robust standard operating procedures (SOPs) and preparing for regulatory inspections and audits, this role ensures the facility's operations align with the stringent requirements of the pharmaceutical manufacturing industry.

A key aspect of this position is driving our quality assurance program. The 503B Pharmacist will oversee environmental monitoring, sterility testing, and validation processes, ensuring all compounded medications meet rigorous quality standards. Additionally, they will investigate and resolve any quality-related issues or deviations, including reviewing customer complaints and adverse drug events. This thorough approach ensures that Empower consistently delivers medications of the highest quality, maintaining our core values.

The 503B Pharmacist will ensure efficiency and adherence to procedures, manage inventory of raw materials, and maintain robust documentation practices. By fostering a culture of continuous improvement and excellence, the 503B Pharmacist will support the Training Department in developing and executing compliance-related training programs to mitigate potential risks associated with sterile manufacturing operations.

We invite you to apply for this impactful position and join us in our mission to produce innovative medications that help people live healthier, happier lives. At Empower, you will have the opportunity to make a significant difference in expanding access to quality, affordable medication while working in a dynamic and supportive environment. Together, let's drive the future of healthcare and ensure the highest standards of quality and compliance.

Duties and Responsibilities

• Ensures the facility operates in full compliance with FDA 503B regulations, state, and federal laws, and relevant USP standards.
• Collaborates with cross-functional teams to develop comprehensive SOPs and implements to maintain regulatory compliance.
• Assists with 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.
• Conducts thorough investigations and implements effective resolutions of any quality-related issues or deviations.
• Assists with the review, investigation and reporting of customer complaints and adverse drug events per regulatory requirements.
• Manages 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.
• Assists 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 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.

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 accommodation 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 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.

Knowledge and Skills

• In-depth knowledge of compounding regulations, current good manufacturing practices and state laws related to outsourcing facilities.
• Strong leadership and communication skills.
• Proficient in Microsoft Office Skills-Excel, Word, PowerPoint, Outlook.

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.

Experience and Qualifications

• Doctor of Pharmacy (Pharm.D.) degree from an accredited institution.
• 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.
• Certification in sterile compounding (e.g., Board Certification in Sterile Compounding).
• Active pharmacist license in the states of New Jersey, Texas, Alabama, Arkansas, Indiana, Kansas, Kentucky, Massachusetts, Michigan, Nevada, New York, North Dakota, Ohio, Oklahoma, Oregon, Vermont, Virginia, West Virginia, and Mississippi.
• Other State Pharmacist Licenses as 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.