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

Empower Pharmacy invites you to join our team as a Senior Quality Assurance Specialist, where you will play a pivotal role in upholding the highest standards of quality and compliance. This is a crucial role in our pursuit of excellence and innovation in pharmaceutical manufacturing. By driving quality assurance initiatives, you contribute directly to our mission of producing innovative medications to help people live healthier, happier lives.

Your daily responsibilities will include supporting department initiatives, reviewing manufacturing and environmental monitoring data, and managing compliance with current Good Manufacturing Practices (cGMP). This position is integral to maintaining our reputation for quality, affordable medications, directly impacting the lives of those we serve.

You will collaborate closely with the Quality Assurance Supervisor to enhance our Quality Management System, ensuring continuous improvement in all processes. This role offers the opportunity to significantly impact our operational efficiency and quality output, making it ideal for someone passionate about upholding and elevating standards within the pharmaceutical industry. Moreover, you will play a critical role in training and mentoring team members, thereby fostering a culture of quality and compliance at Empower.

If you are detail-oriented with a strong understanding of cGMP, USP guidelines, and quality control processes, we encourage you to apply for the Senior Quality Assurance Specialist position at Empower. Join us in our vision of expanding access to quality, affordable medication.

Duties and Responsibilities

• upports 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.
• 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.
• Ensures company is following established Standard Operating Procedures (SOP).
• 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.
• Follows all regulatory, Current Good Manufacturing Practice (cGMP) and US Pharmacopia (USP) guidelines as required by job function.
• Ensures all work is performed and documented in a timely manner and according to approved SOP and in general compliance with cGMP.
• Leads, supports, and performs activities in incidents and non-conformance investigations.
• Assists and collaborates with the Quality Assurance Supervisor.
• 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 or revised processes as they occur.
• Responsible for maintenance of retained sample storage.
• Follows and encourages safety and appropriate regulatory guidelines.
• 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 work day 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.
• 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.
• Previous experience in technical writing and conducting root cause analysis.

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.