Sr. Manager, Microbiology and Sterility Assurance

3 weeks ago

Grand Rapids, United States Grand River Aseptic Manufacturing Full time

Quality, Service, Collaboration, Courage. Do you exhibit these values and wish to be around others that do too? Are you interested in making a difference in your community and the world? Are you looking for a place where you can grow and learn in a diverse, community-minded culture? If these statements resonate with you, Grand River Aseptic Manufacturing (GRAM) welcomes you to apply to join our community of dedicated individuals improving lives every day.Overview of this Position: This position oversees the operations and management of the QC Microbiology laboratories performing environmental/critical utility monitoring, sterility testing and other client-specific microbiology testing in support of aseptic manufacturing operations. Oversight of laboratory compliance, operations and cross-functional interaction, oversight of laboratory validation activities as it relates to new equipment and methods, qualification and oversight of contract laboratories performing analysis on behalf of GRAM, resource planning as it relates to both personnel, facilities and equipment, strategic planning for future lab growth (technology, staffing, support systems, etc.), and oversight of laboratory training programs.Non-Negotiable Requirements: Bachelor's degree in Life Sciences.5 years of prior management/leadership experience at a minimum.10-12 years of prior experience in a regulated laboratory or pharmaceutical manufacturing environment at a minimum.A thorough understanding of cGMP, FDA guidelines and multinational regulatory/compendial standards is required; in-depth knowledge of other best practice resources such as PDA, ISPE, ICH, ISO, etc.Experience and expertise in pharmaceutical laboratory operations in support of manufacturing of regulated products.Prior experience interacting with regulatory authorities.Must have proficient computer skills in Microsoft Word, Excel, and Outlook. Preferred Requirements: Bachelor's degree in Microbiology. Responsibilities Include (but are not limited to): Provide leadership to QC Microbiology Managers and senior personnel. Responsibilities include hiring, managing, motivating, resource allocation, coaching and mentoring.Ensure adequate QC support of GRAM operations across all shifts, including occasional weekend support.Develop and maintain resource plans addressing personnel, facility, and equipment capacity to ensure adequate support of current and future operations.Active management and improvement of laboratory compliance, operational efficiency, and customer service (internal and external customers).Active engagement with project teams to provide accurate timelines for completion of project-based work within the laboratory, and to identify future technology and staffing needs.Draft and review technical investigations, protocols, and reports; offer conclusions and recommendations based upon study outcomes.Oversee laboratory and environmental investigations as needed, ensuring root causes are identified and addressed with corrective and preventive actions, and trends are identified and addressed as needed.Determine impact of microorganisms on processes/products and evaluate the effectiveness of contamination control strategies on the manufacturing environment.Ensure that trending is performed on a routine basis and that periodic summaries are compiled. Assess impact of trends and implement appropriate control strategies to respond to negative trends. Oversee laboratory method development and validation activities as required, including timelines and associated protocols and reports.Plan and participate in quality audits of contract laboratories and other vendors to ensure third parties meet all requirements for qualification. Oversee contract laboratory interactions to maintain strong vendor relationships; assess contract laboratory network to ensure current and future needs are met (including redundancy).Routinely assess contract laboratory performance (both technical and with regards to customer service); manage closely to ensure optimal efficiency.Ensure that trending is performed on a routine basis and that identified trends are addressed via corrective / preventive actions. Interface with auditors, including client representatives and regulatory agencies as needed.Review new project proposals to ensure adequate laboratory capabilities and resources are available to support future business opportunities. Full job description available during formal interview process. What Sets GRAM Apart from Other Employers: MEDICAL BENEFITS starting day 1: Blue Cross Blue Shield medical and dental, vision, life insurance, and disability benefits are available to you and your family on your first day of work, with the company paying for 75% of the cost Once eligible for the 401(k) program, all your contributions are immediately 100% vested, and you are immediately vested in GRAM contributions as well. We also offer generous off-shift premiumsPaid VOLUNTEERISM starting day 1: GRAM encourages giving back to our community by offering 16 hours of paid volunteer time per calendar yearPTO: Full-time employees accrue up to 17 days of time off per calendar year. You choose how to use this time for your vacation, sick, or mental health needsWELLNESS TIME OFF: We offer all employees one (1) paid day of Wellness Time Off (WTO) per quarter to invest in self-care, take some downtime, or whatever you choose.PAID HOLIDAYS: We offer 10 paid holidays per calendar year with immediate eligibility PAY: Depends on Experience and is discussed during the interview process. If you meet the required criteria listed above, GRAM welcomes you to apply today

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