Senior Microbiologist

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 Sr. Microbiologist serves as the technical subject matter expert with regards to environmental control in an aseptic processing operation, and all other microbiology testing related to customer products and GRAM operations. The responsibilities of this position require effective cross-functional interaction at all levels, working within and leading teams to ensure compliance and drive continuous improvement of environmental control and microbiology testing.

Non-Negotiable Requirements:

• Bachelor's degree in Microbiology and/or other related discipline.
• Minimum of 8 years of experience a Microbiology laboratory supporting an aseptic manufacturing process.
• Experience and expertise in aseptic manufacturing of regulated products with a thorough understanding of cGMP, FDA guidelines and multinational regulatory standards is a must.
• Proficient computer skills in Microsoft Word, Excel, and Outlook.

Responsibilities Include (but are not limited to):

• Ensure all microbiology personnel are educated in the most current industry trends, best practices and expectations with regards to aseptic manufacturing, environmental control and monitoring, and microbiology testing.
• Ensure microbiology processes and procedures remain in compliance with SOPs, CFR, FDA, DEA and cGMP requirements, and industry best practices; propose and implement process/procedure changes as needed to ensure alignment with requirements.
• Lead and/or actively participates in technical projects pertaining to microbiology testing processes, including but not limited to method development, transfer and validation activities, sanitization studies, media fill qualification activities, etc.
• Perform method validation/ suitability for microbiological tests, specifically bioburden and endotoxin testing.
• Perform trending analyses of data collected via environmental, personnel and utility monitoring in support of investigations, Quality Management Review, Annual Product Review, etc.; publish conclusions and make recommendations for process changes as applicable.
• Investigate and document any identified excursions or trends, including root cause analysis, impact assessment, and identification of corrective/preventive actions.
• Perform/review/approve Environmental and Laboratory Investigations for any out of specification results.
• Plan and implement corrective and preventive actions (including procedure and test method revisions), and assist/measure the effectiveness of such changes.
• Assess process/procedure changes proposed by others for potential impact on environmental monitoring/microbiology testing processes.
• Author technical protocols and reports for QC Microbiology.
• Coordinate and/or conduct training for new laboratory personnel; provide technical assistance to laboratory personnel as needed.
• Coordinate with contract testing laboratories and experts as needed.
• Participate in vendor, client and regulatory audits.

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.