Empower Pharmacy
Manager, Microbiology 503B - East Windsor, NJ
Empower Pharmacy, East Windsor, New Jersey, United States,
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 Manager, Microbiology plays a key role in ensuring the safety, quality, and compliance of our microbiological processes, directly supporting Empower’s commitment to people, service, quality, and innovation. This position is responsible for overseeing the day-to-day operations of the microbiology laboratory, ensuring that critical deliverables and timelines are met. Through leading environmental monitoring, microbiological testing, and contamination control, this role is instrumental in maintaining the highest quality standards across all aspects of production. This position manages a team of microbiologists and technicians, providing leadership in areas such as microbial testing, environmental monitoring, and method qualification. The manager is responsible for conducting investigations into out-of-specification results, overseeing media fill process simulations, and ensuring adherence to regulatory standards such as Current Good Manufacturing Practice (cGMP). The role is vital in driving continuous improvement by analyzing data, producing trend reports, and implementing corrective actions to prevent quality issues. Collaboration is at the heart of this role, as the Manager works closely with cross-functional teams, including Quality Assurance, to support product release, audits, and regulatory inspections. By fostering a culture of teamwork, professional growth, and continuous learning, this role helps drive excellence in microbiology operations. If you are passionate about quality and eager to contribute to producing innovative medications that help people live healthier, happier lives, we encourage you to apply and be part of our mission to expand access to quality, affordable medication.
Duties and Responsibilities
Manages the day-to-day operations of the microbiology laboratory and oversees personnel to ensure critical deliverables and timelines are met. Oversees staff and procedures for microbiological testing, including environmental monitoring (EM), water sampling and testing, Total Organic Carbon analysis, conductivity, bioburden, Gram stains, microorganism identification, endotoxin testing, reagent qualification, and contamination control. Manages environmental monitoring of classified aseptic production rooms by managing sample incubation, results readout, and results reporting including contact plates, particle counts, microbial ID testing, and personnel monitoring. Creates and analyzes quarterly and customized trend reports for environmental and personnel monitoring, excursions, and out-of-trend data to support continuous improvement initiatives. Conducts investigations into out-of-specification results, manages deviations related to microbiology procedures, and performs microbial method qualifications and growth promotions as needed. Manages the shipment of microbiology-related test samples to outsourced labs, reviews results, and oversees aseptic media fill process simulations and QC microbiology equipment and software validation, maintenance, and calibration. Performs sterility and endotoxin method verifications per United States Pharmacopeia (USP) guidelines, supports the implementation of micro lab practices for USP sterility testing, and supports all EM qualifications for personnel, facilities, and processes. Writes, reviews, and revises standard operating procedures and other documentation per cGMP guidelines, supports audit and inspection readiness, and fosters a collaborative work environment by encouraging teamwork, professional growth, and knowledge sharing. Adheres to personal hygiene, garbing, and Personal Protective Equipment standards per USP regulations when working inside of the sterile and nonsterile hazardous and nonhazardous labs. Performs other duties as 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 regularly required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl.
Knowledge and Skills
Working knowledge of aseptic manufacturing environmental monitoring and pharmaceutical for sterile areas is required. Good working knowledge of FDA cGMP, and data integrity requirements. Proficient in Microsoft Office Skills-Excel, Word, PowerPoint, Outlook. 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.
Experience and Qualifications
Bachelor’s degree in Microbiology, Biology, Biochemistry or equivalent; Master’s degree preferred. Minimum of 7 years of experience in a microbiology laboratory in a Food and Drug Administration (FDA) –regulated environment required and a minimum of 3 years of supervisory experience. Experience in developing microbiological assays (sterility, endotoxin, morphology, microbial ID).
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.
#J-18808-Ljbffr
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 Manager, Microbiology plays a key role in ensuring the safety, quality, and compliance of our microbiological processes, directly supporting Empower’s commitment to people, service, quality, and innovation. This position is responsible for overseeing the day-to-day operations of the microbiology laboratory, ensuring that critical deliverables and timelines are met. Through leading environmental monitoring, microbiological testing, and contamination control, this role is instrumental in maintaining the highest quality standards across all aspects of production. This position manages a team of microbiologists and technicians, providing leadership in areas such as microbial testing, environmental monitoring, and method qualification. The manager is responsible for conducting investigations into out-of-specification results, overseeing media fill process simulations, and ensuring adherence to regulatory standards such as Current Good Manufacturing Practice (cGMP). The role is vital in driving continuous improvement by analyzing data, producing trend reports, and implementing corrective actions to prevent quality issues. Collaboration is at the heart of this role, as the Manager works closely with cross-functional teams, including Quality Assurance, to support product release, audits, and regulatory inspections. By fostering a culture of teamwork, professional growth, and continuous learning, this role helps drive excellence in microbiology operations. If you are passionate about quality and eager to contribute to producing innovative medications that help people live healthier, happier lives, we encourage you to apply and be part of our mission to expand access to quality, affordable medication.
Duties and Responsibilities
Manages the day-to-day operations of the microbiology laboratory and oversees personnel to ensure critical deliverables and timelines are met. Oversees staff and procedures for microbiological testing, including environmental monitoring (EM), water sampling and testing, Total Organic Carbon analysis, conductivity, bioburden, Gram stains, microorganism identification, endotoxin testing, reagent qualification, and contamination control. Manages environmental monitoring of classified aseptic production rooms by managing sample incubation, results readout, and results reporting including contact plates, particle counts, microbial ID testing, and personnel monitoring. Creates and analyzes quarterly and customized trend reports for environmental and personnel monitoring, excursions, and out-of-trend data to support continuous improvement initiatives. Conducts investigations into out-of-specification results, manages deviations related to microbiology procedures, and performs microbial method qualifications and growth promotions as needed. Manages the shipment of microbiology-related test samples to outsourced labs, reviews results, and oversees aseptic media fill process simulations and QC microbiology equipment and software validation, maintenance, and calibration. Performs sterility and endotoxin method verifications per United States Pharmacopeia (USP) guidelines, supports the implementation of micro lab practices for USP sterility testing, and supports all EM qualifications for personnel, facilities, and processes. Writes, reviews, and revises standard operating procedures and other documentation per cGMP guidelines, supports audit and inspection readiness, and fosters a collaborative work environment by encouraging teamwork, professional growth, and knowledge sharing. Adheres to personal hygiene, garbing, and Personal Protective Equipment standards per USP regulations when working inside of the sterile and nonsterile hazardous and nonhazardous labs. Performs other duties as 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 regularly required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl.
Knowledge and Skills
Working knowledge of aseptic manufacturing environmental monitoring and pharmaceutical for sterile areas is required. Good working knowledge of FDA cGMP, and data integrity requirements. Proficient in Microsoft Office Skills-Excel, Word, PowerPoint, Outlook. 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.
Experience and Qualifications
Bachelor’s degree in Microbiology, Biology, Biochemistry or equivalent; Master’s degree preferred. Minimum of 7 years of experience in a microbiology laboratory in a Food and Drug Administration (FDA) –regulated environment required and a minimum of 3 years of supervisory experience. Experience in developing microbiological assays (sterility, endotoxin, morphology, microbial ID).
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.
#J-18808-Ljbffr