Manager, Sterile Compounding - Empower Pharmacy
Houston, TX 77064
About the Job
The Manager, SterileCompoundingis responsible for overseeing processes in the production of compounded sterile preparations, while strictly adhering to current Good Manufacturing Practices (cGMP), USP 797/800, and department Standard Operating Procedures (SOP). This position supervises and coordinates the daily activities of Sterile CompoundingSupervisors, Sterile Compounding Technicians, and Sterile Prep Technicians across multiple shifts. The Sterile Compounding Manager coordinates with management and support departments to reach safety, quality, and delivery goals.
Duties and Responsibilities:- Manages assigned manufacturing operations which might include processing source materials, equipment and component preparation and sterilization, aseptic filtration, aseptic filling, lyophilization, inspection, and packaging.
- Manages injectable value stream from beginning to end (supply/scheduling to release).
- Reviews and updates manufacturing documentation associated with the manufacturing areas.
- Responsible for production schedule.
- Coordinates and provides cGMP, job tasks, and safety training for personnel in the manufacturing areas.
- Generates, updates, and maintains area SOP.
- Maintains compliance with regulatory functions (USP and/or cGMP).
- Actively contributes to the resolution of manufacturing equipment and process issues.
- Performs deviation investigations related to assigned areas of responsibility along with implementing corrective actions to prevent the recurrence of such deviations.
- Initiates continuous process improvements.
- Monitors and coordinates inventory with Supply Chain.
- Prepares production-monitoring reports and participates in analysis of product cost and budgeting process.
- Analyzes and makes recommendations regarding capital expenditure and efficiency improvements in the manufacturing areas.
- Interacts with all supporting departments (ex: QA/QC, Facilities & Engineering, Supply Chain, Operations, etc...) to ensure production problems are dealt with promptly and with appropriate quality considerations.
- Assists with the validation of processes and equipment.
- Ensures that all environmental monitoring limits are maintained in all areas.
- Revises, creates and ensures compliance with SOP regarding process changes, regulatory guidelines, or as needed.
- Maintains hourly employee work schedules, monitors attendance, and monitors performance.
- Leads and assists with hiring and interviewing of new employees. Provides coaching andcounseling to area personnel.
- Budgets own time to carry out assigned duties that support business goals.
- Interacts constructively with employees, managers, and cross-functional peers.
- Effectively solves problem issues around sterile manufacturing.
- Substitutes in manufacturing space as needed.
- 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. Ability to lift up to 30 lbs.
Knowledge and Skills:- Understanding of standard concepts, practices, and procedures within the aseptic pharmaceutical field.
- Thorough knowledge and understanding of mechanical systems.
- Knowledge of Microsoft Office 365.
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 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 convey a clear understanding of the unique needs of different audiences.
- Bachelor of Science in Life Sciences or closely related discipline.
- Prior leadership experience in an aseptic production environment is required.
- Registered with the Texas Board of Pharmacy as a Pharmacy Technician /Nationalcertification preferred.
- Current IV Certification preferred.
- Prior cGMP experience manufacturing sterile products preferred.
- 5+ years of management/supervisory experience.
- Strong cGMP, aseptic processing, and USP 797/800 background.
- Must pass gowning tests and procedures and media fill tests to be a qualified cleanroom operator.
- Must be able to gown into cleanroom daily.
- Must be able to work in an aseptic area.
- 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.