Position Summary:
The Quality Control Manager, Microbiology provides daily operational support and manages the Microbiology Laboratory and Environmental Monitoring (EM) Program. This role oversees EM testing to support cleanroom areas and manufacturing processes, as well as coordinates appropriate in process/release testing (sterility/endotoxin/bioburden, etc.) for manufactured drug products and raw materials.
Duties and Responsibilities:
- Manages microbiology laboratory and personnel day-to-day activities to meet critical deliverables and timelines.
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Manages staff, procedures and methods including EM, water sampling and testing, total organic carbon (TOC) analysis, conductivity, bioburden, Gram stains, microorganism identification, endotoxin, reagent qualification, data trending, contamination control.
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Supports environmental monitoring of classified aseptic production rooms, including sample incubation, results readout, results reporting and QC review of data (including, but not limited to, contact plates, viable/non-viable particle counts, microbial ID testing and personnel monitoring).
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Creates quarterly reports, and customized trend reports for environmental monitoring, personnel monitoring, excursions, and out of trend data in support of continuous improvement.
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Conducts investigations regarding out of specifications (OOS) results and addresses and manages deviations related to microbiology procedures.
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Manages the shipment of microbiology related test samples to outsourced labs and reviews the results.
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Performs microbial method qualifications/growth promotions, as needed.
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Manages aseptic media fill process simulations, as needed.
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Oversees QC microbiology equipment and software validation, maintenance, and calibration.
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Performs sterility/endotoxin method verifications per USP guidelines as required.
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Supports the implementation of the micro lab for USP <71> and/or USP <1071> sterility testing.
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Supports all EM qualifications (gowning qualifications, EM performance qualifications, media fills, etc.) activities for personnel, facilities, and process.
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Writes, reviews, and revises standard operating procedures (SOPs) and other documents per cGMP guidelines.
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Supports audit and inspection readiness.
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Fosters a creative and collaborative work environment, encouraging teamwork, professional growth, and knowledge sharing among team members.
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Monitors and evaluates employee performance. Provides constructive feedback as necessary.
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Partners with department director to evaluate department headcount needs and participates in the interviewing process.
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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 frequently 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. The employee must be able to wear proper PPE, including but not limited to scrubs, hair net, beard cover, shoe cover, gloves, N-95 mask, safety glasses, lab gown, full body coverall, full-face and/or half-face respirators while performing their daily tasks in Hazardous and Non-Hazardous Lab controlled environments.
Knowledge and Skills:
- Demonstrated ability to work independently and take initiative on scheduling and meeting deadlines.
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Good working knowledge of FDA cGMP requirements.
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Prior management of direct reports.
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Strong written and verbal communication skills, including ability to communicate effectively with employees and management.
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Proficient in Microsoft Office Skills-Excel, Word, PowerPoint, Outlook.
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Excellent attention to detail.
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Excellent interpersonal skills: ability to communicate effectively (orally and in writing) with all levels of management.
Key Competencies
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Customer Focus: Ability to build strong customer relationships and deliver customer centric solutions.
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Optimizes Work Processes: Know the most effective and efficient processes to get things done, with a focus on continuous improvement.
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Collaborates: Builds partnerships and works collaboratively with others to meet shared objectives.
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Resourcefulness: Secures and deploys resources effectively and efficiently.
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Manages Complexity: Makes sense of complex, high quality, and sometimes contradictory information to effectively solve problems.
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Ensures Accountability: Holds self and others accountable to meet commitments and objectives.
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Situational Adaptability: Adapts approach and demeanor in real time to match shifting demands of different situations.
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Communicates Effectively: Develops and delivers multi-mode communications that convey a clear understanding of the unique needs of different audiences.
Experience and Qualifications:
- Master’s degree in microbiology/Biology/Chemistry or equivalent with 3-6 years of experience in a Quality Control laboratory in an FDA-regulated environment, or Bachelor’s degree in Microbiology/Biology/Chemistry or equivalent with 7-10 years of experience in a Quality Control laboratory in an FDA-regulated environment, required.
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Working knowledge of aseptic manufacturing environmental monitoring for sterile areas is required.
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Experience in developing microbiological assays (sterility, endotoxin, morphology, microbial ID) is preferred.
Benefits:
- No-Cost Medication: Get your prescribed compounded medications at no cost, ensuring your health without the financial burden.
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Onsite Health & Wellness – IV Therapy Drips: Rejuvenate with complimentary onsite IV Therapy drips, enhancing your well-being and energy levels.
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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.
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Telehealth visits: Access board-certified Doctors anytime, anywhere for you and your family.
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Paid & Volunteer Time Off: Enjoy paid time off for personal pursuits and contribute to causes you care about with volunteer time off.
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Paid Holidays (8 scheduled; 2 floating): Celebrate with eight scheduled holidays and two floating holidays, giving you flexibility and time for personal traditions.
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Life & AD&D Coverage: Secure your and your family's financial future with life and accidental death and dismemberment (AD&D) insurance.
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FSA (Flexible Spending Account): Manage healthcare expenses smartly with pre-tax dollars in a Flexible Spending Account (FSA).
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401K Dollar-for-Dollar Up to 4%: Invest in your future with our 401K plan, featuring a dollar-for-dollar match up to 4%.
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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.
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Flexible Schedules: Balance work and life seamlessly with our flexible scheduling options.
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Rewards & Recognition Program: Your hard work doesn't go unnoticed – enjoy rewards and recognition beyond your paycheck.
Additional Voluntary Benefits
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Accident Insurance: Pays a lump sum benefit to help cover expenses following an accidental injury.
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Hospital Indemnity Insurance: Enhance your peace of mind with supplemental hospital insurance for unexpected stays.
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Critical Illness: Protect your finances from the expenses of a serious health issue.
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Short-Term Disability: Protect your income during illness or injury with short-term disability coverage.
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Supplemental Life & AD&D: Add an extra layer of financial protection for you and your loved ones with supplemental life and AD&D coverage.
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Legal Services: Access professional legal assistance to address concerns confidently.
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Identity Theft Protection: Safeguard your identity and finances with our identity theft protection benefit.
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Pet Insurance: Care for your furry family members with our pet insurance coverage.
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Employee Assistance Program: Confidential counseling and support services for a holistic approach to your well-being.