Supervisor, Quality Operations 503B - Houston, TX - Empower Pharmacy
Houston, TX 77041
About the Job
The Supervisor, Quality Operations, plays a critical role at Empower Pharmacy by ensuring that our manufacturing processes consistently meet the highest standards of quality and compliance. This position is vital to maintaining our commitment to people, service, quality, and innovation, overseeing the daily operations that safeguard the integrity of our aseptic sterile filling and finishing. Your leadership in this role will ensure that every batch produced adheres to the strict regulatory guidelines that define Empower’s reputation for excellence.
In this role, you will manage key areas of Quality Operations, including real-time oversight of manufacturing processes, batch record review, and investigation management. Your work will ensure that quality is built into every step of the production process, with a focus on right-first-time auditing and timely batch release. By leading root cause analyses, CAPA processes, and investigations into any deviations or product complaints, you will continuously drive improvements that enhance the overall efficiency and reliability of our operations.
Collaboration is a key element of this position, as you will work closely with cross-functional teams to implement improvements in procedures and processes that align with regulatory requirements and company standards. Your ability to optimize workflows, track performance metrics, and manage investigations will play a significant role in advancing Empower’s mission of producing high-quality medications. Through your leadership, you will foster a culture of accountability, precision, and proactive problem-solving across the Quality Operations team.
Join us at Empower Pharmacy and contribute to our mission of producing innovative medications that help people live healthier, happier lives. If you are passionate about driving operational excellence, ensuring compliance, and making a meaningful impact on patient health, we invite you to apply. Be a part of a company that values quality, service, and innovation, and help us expand access to affordable, life-changing medication.
Duties and Responsibilities:- Oversees the daily operation of the Quality Operations function, including any of the three key focus areas: Real-time floor-level oversight of manufacturing operations, batch record review and lot disposition, and investigation management.
- Ensures that the real-time auditing team is achieving on-the-floor quality right first time for a three (3) shift aseptic sterile filling and finishing operation.
- Leads the daily efforts of the batch release team to ensure all batch documentation is reviewed for adherence to procedure and applicable regulations.
- Optimizes, tracks and improves the batch release process to ensure batches are consistently dispositioned within their allotted cycle time.
- Documents and reports results and key findings to drive change in behavior.
- Ensures the team is cross trained to collect environmental monitoring samples if necessary.
- Serves as quality subject matter expert in the preparation/revision of operating procedures and specifications.
- Reviews/approves routine change control requests as designated.
- Designs and oversees the implementation of improvements in streamlining processes and procedures in the areas of compounding, validation, change control, laboratory, and risk assessments.
- Uses incident and CAPA activities and processes to drive quality improvements and responds to process and service issues.
- Leads root cause analysis and CAPA for audit observations, product complaints, product non-conformances, and in-process deviations.
- Directs the investigation of excursions in manufacturing or other related operations.
- Performs final review of test data/reports to ensure conformance to the established specifications and standard operating procedures.
- Documents results of deviation and complaint investigations, causal analysis, corrective actions, and preventive actions.
- Performs other duties assigned.
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:- Thorough knowledge of pharmaceutical manufacturing/controls required.
- In-depth knowledge of USP <797>, current good manufacturing practices, Food and Drug Administration regulations (21 Code of Federal Regulations Parts 210, 211), and International Council for Harmonisation regulations.
- Effective communication skills, both written and verbal.
- Leadership skills and the ability to facilitate the work activities of others.
- Proficiency with computer software, SharePoint preferred.
- Ability to act effectively as a member of a team to resolve problems.
- Good organizational and time management skills.
- Ability to work autonomously within established procedures and practices.
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.
Values
- People: Our people define who we are as a company, and we believe that understanding and addressing the needs of our team, clients, and community is fundamental to fostering a culture of support and growth.
- Quality: Quality stands at the core of our mission, reflecting our commitment to excellence in every medication we produce.
- Service: We are here to serve others. Every interaction with our patients, providers, employees and other stakeholders comes from a place of service.
- Innovation: By continuously exploring new methodologies and embracing technology, we ensure that every solution we offer is at the forefront of pharmaceutical care.
- Bachelor of Science degree in a technical or scientific discipline with 5 years of experience in pharmaceutical quality (including at least 3 years in a supervisory role).
or
- A minimum of 8 years of experience in pharmaceutical quality (including at least 3 years in a supervisory role).
- Experience working in a sterile, aseptic manufacturing environment required.
- Experience with international regulatory agencies highly desirable.
Preferred American Society for Quality (ASQ) Certified Quality Auditor, ASQ Certified Manager of Quality/Organizational Excellence, or Software Quality Assurance Registered Quality Assurance Professional.
- 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.