Complaint Handling Specialist

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.  

As a Complaint Handling Specialist at Empower, you are more than just a crucial link in our quality chain; you are the catalyst for transformation, turning customer feedback into actionable insights and robust improvements. In this dynamic role, you will harness your investigative skills to delve into customer concerns, ensuring that every voice is not only heard but also acted upon with the utmost precision and care. 

Tasked with the critical mission of upholding our standards, you will meticulously analyze and resolve customer complaints, craft detailed investigative reports, and ensure compliance with regulatory requirements by reporting adverse drug events directly to the appropriate state or federal agency. This role demands a sharp eye for detail, a firm commitment to accuracy, and a relentless pursuit of excellence.

 Join our team and step into a role where your efforts are directly tied to enhancing product quality and customer trust. This is your opportunity to impact our continuous improvement processes and contribute significantly to our commitment to delivering high-quality, reliable products. Here, every challenge is a chance to innovate and every day brings an opportunity to excel.

• Leads activities in handling Customer complaints and conducting investigations, product Quality and Adverse Drug Events (ADE) complaints and investigations, ADE reporting, and trending complaint data.
• Responsible for area SOPs.
• Responsible for submitting any reportable complaints to the FDA, including acting as the point of contact for FDA complaint follow-up.
• Tracks and trends complaints, ensuring they are closed promptly and integrated with other quality systems such as Biannual Product Reviews, NCIs, etc.
• Assists with clinical and product inquiries, as well as product-related incidents.
• Assists and collaborates with cross-functional teams on assigned duties or projects.
• Ensures all work is performed and documented promptly, according to approved SOPs, and complies with State Board of Pharmacy requirements.
• Demonstrates a high level of discretion in timely identifying and resolving events that could potentially impact the quality of products and processes.
• Follows and encourages safety and appropriate regulatory guidelines.
• Performs other duties as assigned.

To succeed in this job, an individual must be able to satisfactorily perform each essential function. 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 job responsibilities, the employee is required to talk and listen. The employee is often required to remain stationary for a significant amount of the workday and frequently use their hands and fingers to handle or feel to access, input, and retrieve information from the computer and other office productivity devices. The employee must regularly 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 stoop, kneel, crouch, or crawl. Visual abilities required by this job include close vision.

• Strong technical writing skills are required.
• Knowledge of pharmaceutical manufacturing/controls.
• Ability to work autonomously within established procedures.
• Working knowledge of pharmaceutical regulations (USP, cGMP).
• Proficient in Microsoft Office skills, such as Excel, Word, PowerPoint, and Outlook.

Key Competencies

• Customer Focus: Ability to build strong customer relationships and deliver customer-centric solutions.
• Optimizes Work Processes: Knows the most effective and efficient processes for completing tasks, focusing 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 solve problems effectively.
• Ensures Accountability: Holds self and others accountable to meet commitment.
• Situational Adaptability: Adapts approach and demeanor in real time to match the shifting demands of different situations.
• Communicates Effectively: Develops and delivers multi-mode communications that clearly understand different audiences' unique needs.

• A bachelor’s degree in a technical or scientific discipline or equivalent experience is required.
• Previous experience with sterile drug manufacturing operations is required. Industry experience in non-sterile pharmacy or manufacturing operations, terminal sterilization of finished goods, 503A Compounding Pharmacy, 503B Outsourcing Facility, sterile finished dosage forms (IV bags, syringes, vials, pellets, etc.), and 21 CFR is preferred. 

• 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