Quality Control Specialist

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 QC specialist is responsible for working within the Quality Control group, ensuring compliance with new and existing quality standards and regulations, implementing quality focused initiatives, and most importantly the testing of raw materials, investigating the test results and documenting of non-conformances. The QC Specialist will also assist and provide support to various Quality based programs throughout the company which contribute to the overall development of company policies and procedures.
Duties and Responsibilities

• Follows, assists and collaborates with the Quality Control Manager in all matters
• Provides analytical support in the QC Raw Material Team
• Performs testing, review and release of raw materials and consumables
• Ships and track materials to outside laboratories
• Performs in process or release testing of drug product as needed
• Tracks and trends data to proactively avoid non-conformances
• Responds to alerts/action levels as necessary and is technically capable of resolving issues
• Escalates to Quality management as needed
• Utilizes lab instruments for QC testing such as a FTIR, pH meter, HPLC, BET, TOC, and similar testing
• Provides support across the QC environment
• Performs the appropriate non-conformance investigation into any preparation such as any compounded sterile preparation, compounded non-sterile preparation or raw material which may have fallen outside the established specifications
• Initiates and assists in preparing information and/or reports due to a nonconformance that may include but is not limited to the following:
• Out of Specification (Analytical)
• Deviations and incident reports
• Initiates, tracks, follows-up on Corrective Action and Preventive Action (CAPA)
• Product Quality Complaints
• Adverse Events and Serious Adverse Events

• Facilitates communication with the 3rd party laboratories requesting quotes, reviewing test protocols, monitoring rush testing, lab OOS investigations, stability testing and any other related needs
• Provides support for the company's Material Review Board (Risk Assessment program) and the company's internal audit program
• Assists the company's Research and Development team to coordinate laboratory testing and developing verification protocols as needed
• Develops raw material specifications as applicable
• Writes, reviews, revises and/or establishes standard operating procedures
• Assists with the company's Stability Program
• 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

• Knowledgeable with compound pharmacy practices including, but not limited to current USP <795>, <797>, and <800>, FDA guidance and 21 CFR Part 211
• Must be able to work in a cleanroom space and be gown qualified
• Must be able to handle NIOSH hazardous and non-hazardous chemicals
• Proactive, results-oriented with a strong attention to detail
• Experienced in writing executive summary reports, reviewing technical documents and interpreting statistical data analysis
• Strong organizational and time management skills
• Ability to analyze details and perform structured decision-making
• Must be able to lift 30 lbs. for materials handling
• Must be able to handle hazardous and nonhazardous chemicals
• Good computer skills with knowledge of SharePoint
• Must be able to work independently

Experience and Qualifications

• BS/BA Preferred (Degree in chemistry, biology or similar area of expertise)
• Minimum of 3 years' experience in pharmaceutical Quality Assurance, Quality Control or Regulatory (or Compliance) experience preferred
• Certified Pharmacy Technician 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 3%: Invest in your future with our 401K plan, featuring a dollar-for-dollar match up to 3%
• 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