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Supervisor, Quality Assurance
1 month ago
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
The Supervisor, Quality Assurance (QA) at Empower plays a crucial role in maintaining the integrity and excellence of our pharmaceutical operations. This position is vital for ensuring that our finished products meet the highest quality standards and regulatory requirements. By leading the day-to-day activities of the QA Department, the Supervisor ensures that every step of our production process, from material handling to batch record review and release, is executed with precision and care
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In this dynamic role, the Supervisor will provide vital support and collaboration with the Director of QA. You will implement and maintain comprehensive QA policies and procedures, ensuring consistency and accuracy across all pharmacy operations. Your expertise will be critical in overseeing the review and release of batch production records, managing corrective and preventative actions (CAPA) investigations, and approving all components and materials related to drug production. Additionally, you will work closely with the Document Control Specialist to ensure that all quality-driven documentation is meticulously identified and stored, adhering to best practices in record-keeping.
As the Supervisor, QA, you will foster a culture of continuous improvement and accountability. Your ability to collaborate with cross-functional teams, including planning and production, will ensure that production and validation schedules are met, and quality-related issues are promptly addressed. You will also play a key role in supporting standard operating procedure (SOP) revisions.
Joining Empower as a Supervisor, QA means becoming part of a mission-driven company dedicated to producing innovative medications that help people live healthier, happier lives. If you are passionate about making a difference and have a keen eye for quality, we invite you to be a part of our journey towards excellence in healthcare.
Duties and Responsibilities
Leads and supervises the day-to-day activities of the QA Dept., such as processing, reviewing, and releasing finished products, including material handling release, manufacturing and packaging operations, laboratory operations, and review and release of production batch records.
Provides guidance, training, and support to ensure compliance with quality standards and regulatory requirements.
Supports, assists, and collaborates with the Director of QA in all matters.
Implements, and maintain QA policies, procedures, and documentation to ensure consistency and accuracy in pharmacy operations.
Ensures adequate and timely review and release of batch production records.
Works with the Document Control Specialists and QA Specialists to ensure any Quality-driven documentation is appropriately identified and stored according to good record-keeping practices.
Oversees CAPA investigations and review any reports or conclusions from such investigations.
Approves or rejects all components, drug product containers, closures, in-process materials, packaging material, labeling and drug products.
Responsible for approving or rejecting all procedures or specifications impacting the identity, strength, quality, and purity of the drug product.
Supports various SOP revisions, as necessary.
Collaborates with cross-functional teams, including planning, to assure that production and validation schedules are met and to address quality-related issues and implement corrective actions and preventive measures.
Supervises the review and approval of qualification and validation documents.
Stays informed of industry trends, regulatory changes, and best practices in quality assurance, and makes relevant updates into departmental policies and procedures.
Promotes accountability, and improvement, and fosters partnerships with multiple departments to achieve team goals.
Completes and communicates annual performance evaluations and provides coaching and feedback to direct reports, recognizing achievements and addressing areas for improvement as needed.
Follows
and implements safety and appropriate regulatory guidelines.
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 accommodation 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
Knowledgeable with compound pharmacy practices including but not limited to current United States Pharmacopeia guidelines
,
, and
, Food and Drug Administration guidelines, and21 Code of Federal Regulations Part 211.
Must be able to work independently and have the ability to provide and implement solutions for a wide range of complex problems.
Ability to write quality related investigations, technical documents, and statistical date.
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
Bachelor’s Degree preferred (degree in chemistry or engineering preferable)
Certified Pharmacy Technician preferred.
Minimum five years' experience in pharmaceutical QA, Quality Control, Regulatory, or Compliance preferred.
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.
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