Calibration Specialist

2 weeks ago

East Windsor Twp, United States Empower Pharmacy Full time
Company Overview

Empower Pharmacy is a pioneering healthcare organization dedicated to delivering high-quality, affordable medications to countless patients nationwide. As the largest 503A compounding pharmacy and FDA-registered 503B outsourcing facility in the country, we cater to the functional medicine sector.

Our commitment to three core principles—People, Quality, and Service—distinguishes us in the industry. Our team of professionals works collaboratively to innovate in manufacturing, distribution, and quality assurance, creating a uniquely integrated healthcare experience. By leveraging our comprehensive pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to enhance medication accessibility and affordability.

Joining our team means becoming part of a mission. We empower our employees to innovate, grow, and enact meaningful change within the healthcare landscape. If you are a visionary who flourishes in a dynamic, transformative environment, Empower Pharmacy is your ideal workplace. Here, you will be encouraged to share your insights, broaden your expertise, and engage in projects that truly impact lives. We prioritize our team members' well-being, offering a supportive and stimulating work environment where your contributions are valued and celebrated.

Let’s transform healthcare together. Become part of something remarkable.

Position Summary

The Calibration Specialist is essential in guaranteeing the accuracy and dependability of our instruments and equipment, which is vital for maintaining the highest quality standards at Empower Pharmacy. This role is crucial in fulfilling our dedication to producing superior medications that enhance the health and wellness of our communities. By proficiently managing the calibration schedule and formulating effective calibration methods, the Calibration Specialist ensures that all equipment functions optimally, supporting our mission to broaden access to quality, affordable medications.

In this engaging position, you will collaborate with various departments, including Engineering, Quality Assurance, Production, and Laboratory teams, to assess and calibrate critical instruments. You will develop and refine calibration standard operating procedures (SOPs), Master Specifications, and work instructions, ensuring they adhere to the highest standards of precision and appropriateness. Your expertise will also be vital in creating and managing Calibration templates within our Computerized Maintenance Management System (CMMS), working closely with the Preventative Maintenance Coordinator and Engineering teams to conduct regular reviews and internal audits.

The Calibration Specialist will analyze data trends to optimize calibration intervals, ensuring consistent operation without compromising business efficiency. Additionally, you will support quality and production systems by conducting thorough follow-up reviews and addressing any non-conformance issues in collaboration with Quality Assurance (QA) and Operations teams.

Join us at Empower Pharmacy, where your meticulous attention to detail and commitment to excellence will directly contribute to our mission of producing innovative medications. In this role, you will be at the forefront of maintaining our equipment's integrity, ensuring we continue to deliver the highest quality products to our customers. Together, we will drive innovation and foster an environment where precision and reliability are paramount.

Duties and Responsibilities
  • Oversee the calibration schedule for all on-site equipment and instruments, ensuring compliance with calibration timelines.
  • Assist in the development of calibration methods and techniques.
  • Contribute to the creation of calibration SOPs and work instructions for equipment.
  • Develop calibration Master Specifications based on User Requirements.
  • Conduct routine reviews and updates of existing SOPs and Work Instructions to ensure accuracy and relevance.
  • Collaborate with Engineering, Quality Assurance, Production, and laboratory personnel in the evaluation and calibration of critical instruments.
  • Create calibration templates in CMMS according to Calibration work instructions and Master Specifications.
  • Work with the Preventative Maintenance Coordinator and Engineering to perform regular reviews and internal audits to confirm the accuracy of CMMS information.
  • Coordinate with contracted services for equipment calibration by developing specifications, obtaining quotations, and managing the logistics of equipment shipping and receiving.
  • Facilitate instrumentation calibration/recertification with external vendors and internal resources.
  • Assign calibration interval dates based on data trends to optimize recalibration frequency.
  • Support quality and production systems by conducting follow-up reviews with departments to maintain consistent operations.
  • Complete non-conformance reports and collaborate with QA and Operations during investigations for out-of-tolerance conditions.
  • Adhere to Current Good Manufacturing Practice (cGMP), Good Documentation Practices, and other relevant procedures.
  • Ensure calibration is completed before due dates, maintaining budget and schedule constraints.
  • Responsible for equipment maintenance, diagnostics, and repair in a cGMP regulated environment.
  • Perform other duties as assigned.
Knowledge and Skills
  • Proficient in Microsoft Office Suite, including Excel, Word, and Outlook.
  • Strong mathematical skills, including geometry, algebra, and statistics.
Key Competencies:
  • Customer Focus: Ability to build strong customer relationships and deliver customer-centric solutions.
  • Optimizes Work Processes: Knowledge of effective and efficient processes to achieve objectives, with a focus on continuous improvement.
  • Collaborates: Builds partnerships and works collaboratively with others to meet shared goals.
  • Resourcefulness: Effectively secures and deploys resources.
  • Manages Complexity: Navigates complex information to solve problems effectively.
  • Ensures Accountability: Holds self and others accountable for commitments.
  • Situational Adaptability: Adjusts approach and demeanor in real-time to meet changing demands.
  • Communicates Effectively: Develops and delivers communications that clearly address the unique needs of different audiences.
Experience and Qualifications
  • Associate degree from a college or technical school or 5+ years of related experience/training or an equivalent combination of education and experience.
  • Knowledge and experience in two or more calibration disciplines.
  • Experience with General Calibration and Maintenance Schools, Test Measurement Diagnostic Equipment, or Precision Measurement Equipment Laboratory preferred.
  • Experience in the pharmaceutical and bio-pharma industry, and/or aseptic filling preferred.
  • Ability to obtain Classified Cleanroom Gown Qualifications at 503A and 503B sites.
  • American Society of Quality Certified Calibration Technician certification preferred.
Employee Benefits, Health, and Wellness
  • No-Cost Medication: Access your prescribed compounded medications at no cost.
  • Onsite Health & Wellness - IV Therapy Drips: Enjoy complimentary onsite IV Therapy drips for enhanced well-being.
  • Comprehensive Medical, Dental, and Vision Options: Choose from tailored medical plans, plus dental and vision coverage for you and your family.
  • Telehealth Visits: Access board-certified doctors anytime, anywhere.
  • Paid & Volunteer Time Off: Benefit from paid time off for personal pursuits and volunteer opportunities.
  • Paid Holidays: Enjoy scheduled holidays and floating holidays for personal traditions.
  • Life & AD&D Coverage: Secure your financial future with life and accidental death and dismemberment insurance.
  • FSA (Flexible Spending Account): Manage healthcare expenses with pre-tax dollars.
  • 401K Dollar-for-Dollar Up to 4%: Invest in your future with a matching 401K plan.
  • Company Paid Long-Term Disability: Provided at no cost, replacing 60% of your income during long-term disability.
  • Flexible Schedules: Balance work and life with flexible scheduling options.
  • Rewards & Recognition Program: Enjoy recognition and rewards for your hard work.
Additional Voluntary Benefits
  • Accident Insurance: Coverage for expenses following an accidental injury.
  • Hospital Indemnity Insurance: Supplemental hospital insurance for unexpected stays.
  • Critical Illness: Financial protection against serious health issues.
  • Short-Term Disability: Income protection during illness or injury.
  • Supplemental Life & AD&D: Additional financial protection for you and your loved ones.
  • Legal Services: Access to professional legal assistance.
  • Identity Theft Protection: Safeguard your identity and finances.
  • Pet Insurance: Coverage for your furry family members.
  • Employee Assistance Program: Confidential counseling and support services for your well-being.

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