Manufacturing Specialist, Quality Assurance 503B - Houston, TX

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 Manufacturing Quality Assurance Specialist at Empower Pharmacy, your role is pivotal in upholding the highest standards of product quality and safety throughout our manufacturing processes. You play a crucial part in ensuring that every medication leaving our facilities meets rigorous regulatory requirements and exceeds customer expectations. Aligned with Empower's core values of people, service, quality, and innovation, you are integral to the operational excellence that defines our organization.

You will actively monitor and inspect manufacturing operations, meticulously sampling, and testing products to safeguard their integrity and efficacy. By fostering effective collaboration across departments, including sterile and nonsterile manufacturing teams, you contribute to a cohesive environment focused on delivering pharmaceutical excellence. Your expertise in problem-solving and critical thinking enables you to address quality issues swiftly and effectively. From identifying deviations to implementing corrective actions, you will ensure that production processes remain on track, maintaining compliance with Good Manufacturing Practices (GMP).

As a Manufacturing Quality Assurance Specialist, you will play a proactive role in enhancing our quality assurance processes. Your insights from data analysis and quality metrics will drive initiatives aimed at optimizing efficiency and reducing variability, furthering our mission to expand access to quality, affordable medications that help people live happier, healthier lives.

If you are passionate about quality, driven by innovation, and dedicated to ensuring the highest standards of pharmaceutical manufacturing, we invite you to apply today. Join us at Empower and be part of a team making a meaningful impact.

Duties and Responsibilities

• Monitors and inspects manufacturing processes to ensure product safety and quality.
• Establishes and maintains effective working relationships with personnel involved in sterile and solid dose manufacturing.
• Provides guidance to manufacturing employees as needed.
• Utilizes problem-solving and critical thinking skills to troubleshoot and resolve quality issues, including non-conformances.
• Reviews GMP batch records according to the manufacturing schedule, ensuring accuracy of components, lot numbers, and expiration dates in PK Software batch records.
• Conducts "rounds" in manufacturing areas to:
  • Check cleaning solutions for labeling and expiry.
  • Verify components for labeling and expiry.
  • Ensure correct versions of standard operating procedures and work instructions are in use.
  • Coordinates necessary corrections in documentation following good documentation practices.
  • Verifies cleanroom layout consistency with environmental monitoring performance qualification layout.
  • Reviews cleaning logs and execution.
• Verifies critical manufacturing process steps, such as component lot numbers/expiration dates, weight/volume, and mixing.
• Performs acceptable quality limit inspections as required.
• Acts as backup for Environmental Monitoring Technician, performing environmental monitoring, gown qualification, and media fill proctoring, as necessary.
• Reviews daily inspection work orders to ensure cleanroom equipment is operational.
• Analyzes data and results to identify problem areas and recommends solutions.
• Maintains accurate documentation of quality assurance activities.
• Assists in developing quality assurance processes and procedures.
• Ensures compliance with all applicable regulations and standards.
• Maintains a safe and clean work environment.
• 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 standing and/or in a stationary position for a significant amount of the workday (up to 5-6 hours at a time) 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 will frequently be required to fully gown in aseptic garb for extended periods of time in an environmentally controlled area (3-5 hours) daily and work around cleaning agents, disinfectants, and National Institute for Occupational Safety and Health hazardous chemicals. The employee is regularly required to move about the office and around the corporate campus. The employee is regularly required to walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl. The Employee must be able to lift up to 30 lbs.

Knowledge and Skills

• Knowledge of aseptic operations and state/federal regulations.
• Excellent attention to detail.
• Proficiency in Microsoft Office (Excel, Word, PowerPoint, Outlook).
• Strong organizational and prioritization skills with the ability to multitask.

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 others accountable to meet commitments and objectives.
• 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.
• Associate degree preferred with 2-4 years of related experience.
• Experience in sterile and nonsterile manufacturing 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.