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Lead, QC Microbiology (1st Shift)

Employer
Ferring Pharmaceuticals, Inc.
Location
Parsippany Troy Hills, New Jersey, US
Salary
Competitive
Closing date
Dec 18, 2021

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Job Title: Lead, QC Microbiology (1st Shift) Job Description: Contribute to outstanding innovation + Make braver choices Lead, QC Microbiology (1st Shift) Location: Parsippany As a privately-owned, specialty healthcare company, Ferring focuses on developing life-changing innovations that help people live better lives. Our independence helps us cultivate an entrepreneurial spirit and long-term perspective that enables us to achieve growth and scale while remaining agile and true to our 'people first' philosophy. Built on a 70-year commitment to science and research, Ferring is relentless in pursuit of science that drives powerful discoveries and therapies to help people build families, stay healthy, and stand up to the world's oldest enemy: disease. Summary: The Team Leader position will require the incumbent to oversee 1st shift operation for production support and QC testing. Trains and mentors junior analysts on compendial methods and environmental monitoring. Perform routine quality control testing of raw materials, in-process materials, drug substance, finished goods and stability samples, environmental monitoring (Grade A/B) and water sampling. Performs experimental design, method validation/qualification, equipment qualification and technical transfer activities of compendia methods related to raw materials and finished product. Responsible for authoring development protocols, final summary reports, investigations, change controls, risk assessments, trend reports and training new hires. Subject matter expert for all microbiological methods in accordance to cGMP and GLP guidelines. Collaborates with the QC Supervisor on coordinating weekly schedules, overseeing workflow and metrics, attending management meetings, and reviewing validation protocols. Assists with the budget requests, processing purchase orders, capital equipment acquisitions requests (CAR's). Prepares for self inspection readiness and participates in regulatory audits and walk-throughs. Responsibilities: * Leads a team of highly motivated and talented QC Microbiologists on the 1st shift for routine EM production support and QC testing. * Collaborates with the QC Supervisor on coordinating the weekly/daily schedules and coordinates resources within team and between other departments to meet production and development objectives. * Leads and performs experimental design, compendia method qualifications and assay transfers to ensure successful project transfer and performance in the laboratory. * Assures execution of monitoring and testing programs to assess the quality of raw materials, components, in-process and finished goods, environmental systems/utilities systems and effectiveness of production processes. * Performs water sampling, environmental sampling, and (viable/non-viable) for production and routine monitoring, gas testing, gown qualification and media fills. * Oversees QC document management and archival and inventory control of consumables, media and garments. Assist with the budget requests, processes purchase orders and capital acquisitions requests (CAR's). * Reviews, and performs authorization of GMP data on paper, logbooks and in LIMS, including but not limited to test results and records, validation protocols/reports, method transfer protocols/reports, test methods, equipment records, process transfer activities, change controls, deviations and (OJT) training. * Executes microbiological methods using, but not limited to, Bioburden testing, Microbial Limits Testing, Antimicrobial Effectiveness Testing, Sterility Testing, and Bacterial Endotoxin Testing, and Microbial and Fungal Identification. * Oversee environmental performance qualification of new cleanroom areas. Performs risk assessments and develops sampling plans and site maps for new cleanroom areas. * Trains junior analysts and develops training plans and/or oversee training activities for new hires. * Issues deviations, laboratory investigations, corrective actions change controls, and monitors effectiveness checks in LIMS and in QA-Track. * Represents the QC Microbiology department in cross functional teams and internal/external meetings. * Monitor and reports on quality metrics and progress toward quality goals. * Authors SOPs, test method, specifications, developmental protocols, method qualification protocols/reports, annual product reviews and technical reports as needed. * Monitors the life cycle microbiology instruments for preventative maintenance and calibration - ensuring conformance to specifications. Ensures lab equipment conforms to specifications. Oversees the execution of IQ/OQ/PQ of new purchased instruments in a timely manner. Troubleshoots instruments in the lab when necessary. * Develop team members by continually growing employees through challenging experiences, identify areas for development, actively coach, and provide development and learning opportunities. * Prepares for self inspection readiness and participates in regulatory audits and walk-throughs. Requirements: * Bachelor of Science Degree in Biological or Environmental Sciences from an accredited College or University is required. Master of Science degree preferred. * A minimum of 8 years of QC laboratory (pharmaceutical or biopharmaceutical industry) with a Bachelor's Degree or 4 years of industry experience with a Masters degree. * Working knowledge of Standard Operating Procedures (SOPs), analytical test methods, and generally accepted laboratory practices. * Expertise with performing laboratory investigations, change controls, and associated CAPA under limited guidance. * Knowledgeable in Labware LIMS configuration of new analyses and product specification. * Microbiological method development, transfer, and validation experience is highly preferred. * Prior laboratory supervisor experience is a plus. * Subject matter expert for all microbiological methods in accordance to cGMP and GLP guidelines and componential requirements and familiar with lean six sigma principles. * Knowledge of USP/EP/cGMP and ICH guidelines; Microbiology techniques and instrumentation; Laboratory Information Management System (LIMS); Global Quality Tracking System (TrackWise); Microsoft Office; Lean Six Sigma concepts; Lean Labs; project management; formal Quality Change Control, Investigations, and Documentation systems, and Quality Risk Management including risk assessments. * Excellent written and verbal communication and interpersonal skills; establishes key relationships within business lines. * Ability to work independently and identify issues, presents complex problems with possible solutions, and actively takes leadership role to resolve of issues. * Applies disciplined principles, appropriate procedures, and leadership skills to action plan and contribute to executing toward team/project goals. * Ability to receive feedback from management and other colleagues, takes accountability for actions and personal development. * Consistent correctness and accuracy in tasks, activities, decisions, and documentation; detail oriented behavior. * Good judgment and correct decision making based on Ferring procedures, policy and standards; quality systems knowledge; technical experience; and industry guidance / regulatory authority regulations; decision impact awareness on future quality and compliance as well as impact on own work group, department, and network. * Proactively identifies, takes remedial action, and/or seeks advice when a personal, project or team goal/deliverable is off schedule. * Delivers on high business impact projects/activities/changes. * Able to holistically review and authorize all laboratory data, and has an extensive overall knowledge of all laboratory operations. * Ability to stand on feet for up to four hours at a time. * Be able to lift, push, and /or pull up to 25 pounds. * Meet minimal visual acuity requirements necessary for quality assessments. Join our team and you'll become part of a close-knit family - one in which you'll be listened to and your contributions valued. Surrounded by like-minded people, you'll have the support to achieve more. So if you love to come up with new ways to make a positive difference and see them through, welcome to the team. We are proud to be an Affirmative Action/EEO Employer. EOE Minorities/Females/Protected Veterans/Disabled. We maintain a drug-free workplace and perform pre-employment substance abuse testing. Location: Parsippany, New Jersey

#06022021
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