Quality Operations Specialist 503B - East Windsor, NJ - Empower Pharmacy

Position Summary:

The Quality Operations Specialist is a key role within Empower, focused on ensuring the highest standards of quality and safety across our manufacturing operations. This position directly supports our mission to deliver innovative and affordable medications by providing oversight in critical areas such as product sterility, batch documentation review, and investigation support. Through maintaining strict compliance with regulatory standards and company protocols, the Quality Operations Specialist ensures that every product meets our rigorous standards of excellence, aligning with our core values of service, people, quality, and innovation.

 

In this role, the Specialist will oversee floor-level operations, ensuring that aseptic techniques are followed meticulously and intervening when necessary to halt operations or quarantine products to protect product quality and patient safety. Additionally, the Specialist plays a key role in reviewing Good Manufacturing Practice (GMP) batch records, resolving issues before batch disposition, and providing guidance and coaching to manufacturing teams. By supporting root cause investigations and implementing corrective actions, this role fosters continuous improvement in quality processes.

 

Working closely with cross-functional teams, the Quality Operations Specialist ensures that all aspects of manufacturing operations run smoothly and comply with regulatory requirements. From inspecting critical manufacturing steps to conducting environmental monitoring and maintaining documentation accuracy, this role is essential in maintaining our commitment to quality. We invite candidates who are passionate about ensuring the highest standards of safety and quality to join us in our mission to help people live healthier, happier lives through access to innovative medications.

Duties and Responsibilities:

• Providing floor-level oversight to manufacturing operations.
• Reviewing batch documentation as part of the lot review and disposition process.
• Aiding in the investigation and closure of investigations.
• Ensures product stAccountability to halt operations, segregate, and/or quarantine product if warranted based on incidents, events, adverse conditions.
• Monitors and inspects processes to ensure product safety and quality.
• Establishes and maintains effective working relationships with personnel involved in sterile and solid dose manufacturing.
• Provides guidance and coaching to manufacturing employees as needed.
• Utilizes problem-solving and critical thinking skills to troubleshoot and resolve quality issues, including non-conformances.
• Assists with investigations of varying complexity to determine root cause and potential corrective and preventative actions.
• Reviews GMP batch records according to the Operations schedule, ensuring accuracy of components, lot numbers, and expiration dates in PharmaKnowledge Software batch records.
• Reviews related batch records and associated documentation to identify and help resolve any issues prior to batch disposition.
• Conducts "rounds" in Operations areas to:
  
  • Check cleaning solutions for labeling and expiry.
  • Verify components for labeling and expiry.
  • Ensure correct versions of standard operating procedures and work instructions are in use.
  • Coordinates necessary corrections in documentation following good documentation practices.
  • Verifies cleanroom layout consistency with environmental monitoring performance qualification layout.
  • Reviews cleaning logs and execution.
• Verifies critical manufacturing process steps, such as component lot numbers/expiration dates, weight/volume, and mixing.
• Performs acceptable quality limit inspections as required.
• Acts as backup for Environmental Monitoring Technician, performing environmental monitoring, gown qualification, and media fill proctoring, as necessary.
• Reviews daily inspection work orders to ensure cleanroom equipment is operational.
• Analyzes data and results to identify problem areas and recommends solutions.
• Maintains accurate documentation of quality assurance activities.
• Assists in developing quality assurance processes and procedures.
• Ensures compliance with all applicable regulations and standards.
• Maintains a safe and clean work environment.
• Supports improvement initiatives.
• 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 standing and/or in a stationary position for a significant amount of the workday (up to 5-6 hours at a time) 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 will frequently be required to fully gown in aseptic garb for extended periods of time in an environmentally controlled area (3-5 hours) daily and work around cleaning agents, disinfectants, and National Institute for Occupational Safety and Health hazardous chemicals. The employee is regularly required to move about the office and around the corporate campus. The employee is regularly required to walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl. The Employee must be able to lift up to 30 lbs.

Knowledge and Skills:

• Knowledge of aseptic operations and state/federal regulations required.
• Excellent attention to detail.
• Proficiency in Microsoft Office (Excel, Word, PowerPoint, Outlook).
• Strong organizational and prioritization skills with the ability to multitask.

 

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:

• Bachelor of Science in a science-related discipline required OR at least four (4) years of directly related experience in lieu of the degree requirement.
• Experience in sterile and nonsterile manufacturing required.

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.