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Senior Quality Assurance Specialist

4 months ago

Hightstown, United States Empower Pharmacy Full time
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

As a Senior Quality Assurance Specialist at Empower, you will play a pivotal role in upholding our commitment to producing innovative medications that enhance the health and well-being of our customers. Your expertise and dedication will be crucial in ensuring that all processes and products meet the highest quality standards and regulatory requirements. By joining our team, you will help us achieve our mission of expanding access to quality, affordable medication and contributing to healthier, happier lives.

In this key role, you will assist and collaborate with the Quality Assurance Supervisor to oversee and support functional areas, ensuring adherence to established Standard Operating Procedures (SOP) and governmental regulations. You will meticulously track data relevant to our Quality Management System (QMS), including product lot information and operational errors, to maintain stringent quality controls. Your responsibilities will include ensuring compliance with Current Good Manufacturing Practice (cGMP) and US Pharmacopoeia (USP) guidelines, providing oversight across various departments such as warehouse, manufacturing, inspection, labeling, packaging, batch record review, and product distribution.

Your role will involve performing and reviewing routine manufacturing, environmental monitoring, and quality control data for in-process and finished products. You will also manage master batch records, collect necessary information for production batch records, and oversee the sampling, inspection, and control of product label inventory. With your advanced technical expertise, you will evaluate current processes, provide valuable input, and oversee the training of department employees on new processes. Additionally, you will maintain retention sample storage and lead activities in incidents and non-conformance investigations, demonstrating a high level of discretion in identifying and resolving potential quality issues.

Your role as a Senior Quality Assurance Specialist will be instrumental in driving our commitment to excellence and continuous improvement. Together, we will make a meaningful impact on the health and lives of many, fostering a culture of collaboration, accountability, and safety. Embrace this opportunity to contribute to a company dedicated to making a difference and advancing the future of health and wellness.

Duties and Responsibilities

  • Assists and collaborates with the Quality Assurance Supervisor to support oversight and performance of functional areas, and training regarding processes and documentation as they pertain to quality standards and governmental regulations.
  • Ensures the company is following established SOP and tracks data relevant to the company's Quality Management System (QMS), including but not limited to product lot information, and errors found in various areas of operations.
  • Tracks data relevant to the Company's QMS, including but not limited to product lot information and errors found in various areas of operations.
  • Follows all regulatory, cGMP and USP guidelines as required by job function.
  • Supports department and Company initiatives to ensure quality assurance oversight and adherence to cGMP for various departments and functions such as warehouse, manufacturing processes, inspection, labeling and packaging, batch record review, batch disposition and product distribution as applicable.
  • Ensures all work is performed and documented in a timely manner and according to approved SOP and in general compliance with cGMP.
  • Demonstrates a high level of discretion in the timely identification and resolution of events potentially impacting the quality of products and processes.
  • Evaluates and provides input based on technical expertise and knowledge of current processes.
  • Oversees training of department employees on new processes occurs.
  • Maintenance of retained sample storage.
  • Performs and reviews routine manufacturing, environmental monitoring and quality control data for in-process and finished products.
  • Issues and manages the organization of master batch records, also collects required information for any production batch record as required during the review.
  • Samples, inspects, and controls product label inventory.
  • Follows and encourages safety and appropriate regulatory guidelines.
  • Leads, supports, and performs activities in incidents and non-conformance investigations.
  • 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 accommodations 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 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
  • Excellent attention to detail.
  • Basic PC skills including MS Word and Excel
  • Technical Writing, Root Cause Analysis, Microsoft Office applications,
  • Ability to manage multiple projects concurrently, time management skills.
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
  • High school diploma or equivalent, required. Bachelor's degree in science or related field preferred.
  • Minimum 5 years of experience in Quality Assurance/Control Operations or a related field in the healthcare industry required.
  • 5+ years' experience with cGMP or similarly regulated environment required.
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.