QC Microbiology Manager - Facility Control

Description

Agility, Impact, Methodology. Do you exhibit these values and wish to be around others that do too? Do you thrive in fast-paced environments where agility, adaptability, and high standards go hand in hand? Are you driven to make a meaningful impact, whether through your work, your support of others, or your commitment to your community? Are you motivated by a disciplined, science-based approach that ensures consistent excellence, safety, and integrity in everything you do? 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:

The QC Microbiology Manager - Facility Control oversees the QC Microbiologists/technicians performing environmental monitoring, critical utilities testing and client-specific in-process microbiology testing in support of aseptic manufacturing. Duties include, but are not limited to: oversight of technicians performing environmental monitoring and critical utility monitoring, review of microbiology test results, monitoring facility/personnel performance with regards to contamination control, and investigation of environmental and utility out of trend/out of specification results.

Non-Negotiable Requirements:

• Bachelor's Degree in Life Sciences (Microbiology degree preferred) or a related field, and a minimum of 10-15+ years related work experience.
• At least 4 years of prior management / leadership experience required.
• At least 5 years of prior experience in a sterile manufacturing environment required.
• A thorough understanding of cGMP, FDA guidelines and multinational regulatory standards is required.
• Knowledge of Quality Control, Contamination Control, and Microbiology principles and procedures in a pharma, biopharma, and/or biotech manufacturing environment.
• Experience and expertise in aseptic manufacturing of regulated products is required.
• Must have proficient computer skills in Microsoft Word, Excel and Outlook.

Preferred Requirements:

• Prior experience interacting with regulatory authorities is preferred.

Responsibilities Include (but are not limited to):

• Provide leadership to Quality Control associates of various levels. Responsibilities include hiring, managing, motivating, coaching and mentoring.
• Oversee routine testing on water, utilities, in-process samples, personnel and the environment to detect microorganisms and to obtain information on types and levels of microbial contamination.
• Determine impact of microorganisms on processes/products and evaluate the effectiveness of contamination control strategies on the manufacturing environment.
• Communicate the status of microbiological testing and results trending to QA, Manufacturing, Validation and other departments as needed.
• Draft and review technical investigations, protocols and reports; offer conclusions and recommendations based upon study outcomes.
• Actively participate in environmental investigations and identify/assess corrective and preventive actions.
• Draft, review and approve protocols, reports and procedures.
• Oversee or coordinate micro laboratory capital expense projects as it relates to environmental monitoring and facility control.
• Establish and maintain good practices with regards to testing processes and data management.
• Along with technical services team, ensure that trending is performed on a routine basis and that periodic summaries are compiled, maintain laboratory logbooks and other documents to ensure GDP.
• Along with technical services team, establish and monitor facility control testing strategies for current and future cleanrooms.
• Develop training requirements, ensure all Microbiology personnel are adequately trained and qualified to perform the assigned job functions.
• Perform all job responsibilities in compliance with applicable regulations, standard operating procedures, and industry best practice.

Full job description available during formal interview process.

What Sets GRAM Apart from Other Employers:

BENEFITS starting day 1: Medical, prescription, dental, vision, life insurance, and disability benefits are available to you and your family on your first day of work, with the company paying a portion 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 premiums!

Paid VOLUNTEERISM starting day 1: GRAM encourages giving back to our community by offering 16 hours of paid volunteer time per calendar year!

PAID TIME OFF: You choose how to use this time for your vacation, sick, or mental health needs! PTO: Full-time employees accrue up to 104 hours of paid time off per calendar year, with this amount being prorated your first year. WELLNESS TIME OFF (WTO): In addition to PTO, employees earn 1 hour of wellness time off for every 30 hours worked, to use how 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.