Location: East Windsor, New Jersey Posted: June 25, 2024 Req# 2601 Manufacturing 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 four core values: People, Quality, Service and Innovation. 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 a Pharmaceutical Manufacturing Specialist at Empower, you will be at the heart of our mission to produce innovative medications that transform lives. This critical role ensures our manufacturing processes run seamlessly and efficiently. You will be responsible for planning and executing manufacturing tasks, including scheduling operations, managing materials, and ensuring compliance with stringent industry standards. Your expertise will directly contribute to the production of quality medications that empower people to live healthier, happier lives. In this dynamic position, your analytical skills will be crucial in identifying and addressing gaps in our processes, utilizing manufacturing software and analytics tools to track key performance indicators (KPIs) and enhance overall performance. Collaborating closely with quality and engineering teams, you will play a key role in the implementation of new devices, equipment, and processes, ensuring robust, reliable, and efficient manufacturing operations. Joining Empower means being part of a team dedicated to expanding access to quality, affordable medication. Your contributions as a Pharmaceutical Manufacturing Specialist will be instrumental in advancing our mission and helping countless individuals achieve better health outcomes. If you are passionate about making a difference and eager to innovate within a supportive, forward-thinking environment, we invite you to apply to the Pharmaceutical Manufacturing Specialist position at Empower today. Duties and Responsibilities
- Assists operations in execution of tasks related to manufacturing that are within the realms of any of the following:
- Scheduling and Planning of operations (Monthly-Weekly-Daily-Hourly breakdown).
- Creation and maintenance of Standard Operating Procedures (SOPs), Standard Work Instructions and forms.
- Product Development.
- Quality Control process implementation.
- United States Pharmacopeia (USP) 797 and/or current Good Manufacturing Procedure (cGMP) compliance.
- Material/chemical management, receipt and inspection for release and entry into software for use.
- Primary/Secondary/Tertiary Qualification of materials and ingredients
- Analyzes gaps using spreadsheets and analytics software.
- Tracks manufacturing performance related to KPIs.
- Investigates deviations and Corrective Actions / Preventative Actions with quality, engineering, and operations.
- Identifies and implements improvement initiatives to improve yield, reliability, and/or process robustness.
- Works closely with quality and engineering teams to help implement new devices, equipment, and processes into manufacturing including scale up, Installation Qualifications, Operational Qualification, Performance Qualification protocol drafting and review and implementation assistance, and training and implementation on ground floor.
- Plans for and adjusts to unforeseen responsibilities as the company requires.
- Aid in the strategy and execution of stability batches including protocols, SOP's, materials, etc.
- Helps implement lean manufacturing principles (5S, Gemba, etc.).
- Assists with operations as needed in case of unplanned absences.
- Inventory management and ordering of everyday chemicals, materials, and supplies.
- Responsible for waste management and documentation.
- Initiate Non-Conformance Incidents.
- 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. Employee may need to gown into a cleanroom environment therefore must be able to fully gown in aseptic garb . 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. Knowledge and Skills
- Understanding of standard concepts, practices, and procedures within the pharmaceutical field and aseptic practices.
- Ability to operate a forklift preferred.
- Highly level proficiency with Microsoft Office (Excel, Word, PowerPoint).
- Must be able to pass media fill tests bi-annually.
- Must be able to gown into cleanroom (daily if needed).
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
- High school diploma or equivalent required. Degree in a life science or engineering highly preferred.
- 3 years prior experience with cleanroom manufacturing or sterile compounding.
- Pharmacy Technician trainee or certification required.
- IV Certification highly preferred.
- Strong cGMP, aseptic processing, and USP 797/800 background.
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.