Lead, Sterile Manufacturing Operator 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 Lead Sterile Manufacturing Operator at Empower is pivotal in maintaining the integrity and efficiency of our sterile compounding operations. This position is essential to our mission of delivering high-quality, innovative medications that adhere to the highest standards of safety and efficacy. By leading operational initiatives, including component preparation, aseptic vial filling, and adherence to sterile preparation schedules, the Lead Sterile Manufacturing Operator ensures that our production processes align with Empower's values of people, service, quality, and innovation.

A key aspect of this role is the meticulous oversight of the sterile environment. The Lead Sterile Manufacturing Operator is responsible for maintaining International Organization for Standardization (ISO) classified environments through rigorous cleaning and adherence to aseptic techniques. This includes performing high-risk sterile compounding, managing production supplies, and ensuring compliance with regulatory standards. By facilitating training for new hires and providing continuous oversight, the Lead fosters a culture of excellence and safety within the team.

Effective communication and problem-solving are crucial in this role. The Lead Sterile Manufacturing Operator generates shift reports, communicates progress to management, and ensures that all tasks are performed compliantly and safely. This position also involves troubleshooting equipment-related issues, overseeing documentation practices, and collaborating with shift supervisors to address non-conformances. By driving daily operations and enforcing schedule adherence, the Lead plays a vital role in achieving production goals and maintaining product quality.

We invite motivated and detail-oriented candidates to join Empower in this dynamic role. By becoming part of our team, you will contribute to our mission of producing innovative medications that help people live happier, healthier lives, and expand access to quality, affordable medication. Your expertise and leadership will be instrumental in advancing our vision and upholding our commitment to excellence.

Duties and Responsibilities

• Leads operational initiatives, including component preparation, mixing and filtration, and aseptic vial filling/crimping operations using automated equipment.
• Tracks and evaluates production output, making recommendations for adjustment to maintain optimal efficiency.
• Analyzes production data to identify trends, bottlenecks, and opportunities for improvement, and reports findings to senior management.
• Ensures that all processes and outputs meet the established quality standards, implementing continuous quality improvement initiatives.
• Enforces adherence to sterile preparation schedules by driving daily operations.
• Assists in workforce allocation and communicates in shift huddles to sterile compounding staff daily.
• Performs high-risk sterile compounding in an ISO-classified current good manufacturing practice environment.
• Maintains an ISO-classified environment through rigorous cleaning and disinfecting of the cleanroom alongside team members.
• Manages change implementation, investigations from non-conformances, and compliance initiatives within operations.
• Facilitates training of new hires in sterile operations.
• Ensures production supplies and components are stocked to appropriate levels and maintained daily.
• Generates shift reports and communicates end-of-shift progress to management.
• Provides oversight to ensure team members conduct tasks compliantly as outlined in department standard operating procedures.
• Troubleshoots equipment-related issues and escalates concerns according to the chain of command.
• Reviews documentation of tasks performed to maintain compliance and product quality.
• Verifies the completion and accuracy of batch records prior to product transfer to visual inspection while maintaining good documentation practices.
• Collaborates with shift supervisors to ensure non-conformances are submitted in a detailed and timely manner.
• 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 frequently required to stand, walk, reach with arms and hands, and occasionally required to climb or balance, and to stoop, kneel, crouch or crawl. Vision abilities required by this job include close vision. The Employee must be able to stand and walk for extended periods of time for consecutive days and work in a confined, controlled environment for extended periods of time. The Employee must be able to lift up to 30 lbs. Employee is required to fully gown in aseptic garb for extended periods of time.

Knowledge and Skills

• Detail-oriented and self-motivated.
• Ability to work in a controlled environment for extended periods of time, functioning effectively as a team.
• Ability to carry out detailed written or oral instructions.
• Ability to add, subtract, multiply, and divide.
• Proficient in using Excel or other spreadsheet software.

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 other accountable to meet commitment.
• 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

• School Diploma or equivalent required.
• Minimum of 1 year compounding experience required.
• Previous role as a lead or mentoring experience preferred.
• Must be currently registered and in good standing as a certified pharmacy technician.

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.