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Aseptic Manufacturing Operator 503B (1st shift)

Empower Pharmacy
East Windsor, NJ Full Time
POSTED ON 2/27/2025
AVAILABLE BEFORE 4/24/2025
Position Summary:
The Aseptic Manufacturing Operator is a vital role within Empower Pharmacy, directly contributing to the production of high-quality sterile products that align with our core values of people, service, quality, and innovation. This position is essential in maintaining the integrity and safety of our manufacturing processes, ensuring that every product we produce meets the highest standards of compliance and excellence.

In this role, the Aseptic Manufacturing Operator will execute processes related to the manufacturing of sterile products within a Current Good Manufacturing Practice (cGMP) cleanroom environment, adhering to International Organization for Standardization (ISO) 5, ISO 7, and ISO 8 classifications. This position requires meticulous attention to detail, as you will be responsible for manufacturing sterile products in strict compliance with master batch records and department-specific Standard Operating Procedures (SOPs). Utilizing appropriate aseptic techniques, you will operate fill-finish and ancillary manufacturing equipment, maintain a sterile environment, and perform critical tasks such as autoclaving, bubble point testing, and material preparation.

As a key member of the manufacturing team, you will be trained and qualified in aseptic operations, ensuring that you are equipped to uphold the rigorous standards required in this role. Your work will directly impact our ability to produce safe, effective medications that help people live healthier, happier lives. This position offers the opportunity to engage in continuous improvement initiatives, such as Lean manufacturing tasks, while also providing guidance to new hires in aseptic operations.

If you are passionate about contributing to a mission-driven organization and are committed to excellence in manufacturing, we invite you to apply for this position. Join Empower Pharmacy in our dedication to expanding access to quality, affordable medication, and making a positive impact on the lives of patients.
Duties and Responsibilities:
  • Executes processes related to the manufacture of sterile products in a cGMP cleanroom environment (ISO 5, ISO 7, ISO 8).
  • Manufactures sterile products accurately and in compliance with master batch records while adhering to department specific Standard Operating Procedures (SOPs).
  • Adheres to 21 Code of Federal Regulations parts 210/211 and United States Pharmacopeia <797>/<800> regulations, cGMP, and department’s SOPs.
  • Utilizes appropriate aseptic technique when performing tasks within the cleanroom.
  • Operates all fill-finish and ancillary manufacturing equipment in order to deliver quality medication.
  • Maintains an ISO classified environment through rigorous cleaning and disinfecting of the cleanroom in accordance with approved procedures.
  • Assists with sterilization of components used in the manufacturing process.
  • Performs essential calculations and completes thorough documentation.
  • Methodically prepares work area and supplies prior to manufacturing.
  • Performs transfer of products from the cleanroom to the Inspection and Labeling team
  • Becomes trained and qualified in the Sterile operation via internal training program.
  • Performs ancillary tasks and duties that support the manufacturing process such as, but not limited to, autoclaving, bubble point testing, material preparation, inventory accounting, organization of components, and various Lean manufacturing tasks (6S, Gemba, Kaizen).
  • Performs other duties and responsibilities within the department to ensure timely execution of the production schedule.
  • Ensures all required hygienic practices and garbing are performed per company policy.
  • Observes and aids in coaching new hires on Sterile operations.
  • Provides overtime support, as needed, to maintain appropriate inventory levels.
  • Assist with special projects, as needed.
  • 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. Employee must be able to fully gown in aseptic garb and work in a confined, controlled environment for extended periods of time (up to 4-6 hours). Employee will work with hazardous substances (drugs) and strong odors (such as, but not limited to, peracetic acid). 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. Employee must be able to stand and walk for extended periods of time for consecutive days. Employee must be able to lift up to 50 lbs.
Knowledge and Skills:
  • Ability to understand, follow, and comply with technical and written documents SOPs as well as detailed oral instructions.
  • Detail-oriented and self-motivated.
  • Problem solver who enjoys collaborating with a team to resolve issues.
  • Ability to add, subtract, multiply and divide.
  • Ability to achieve “Gown Qualified” status within two attempts, allowing entry into the cleanroom.

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
  • 1 years previous manufacturing experience preferred.
  • Previous cGMP or Lean manufacturing experience preferred.
  • Experience with operation of equipment and/or tools preferred.
Benefits:
  • 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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