QC Microbiologist III

Grand River Aseptic Manufacturing; Grand Rapids (MI); On-site; USD 75,000 - 100,000; Full time

Benefits offered by this job

Medical, prescription, dental, vision,

Life insurance and disability benefits

401(k) with immediate vesting

Paid volunteerism starting day 1

Paid time off and holidays

Job summary

Grand River Aseptic Manufacturing (GRAM) in Grand Rapids, MI, is seeking a QC Microbiologist III to uphold quality systems related to environmental control in aseptic processing and microbiology testing across GRAM operations.

The role involves cross-functional teamwork, leading projects on method development, validation, and CAPA, and ensuring safety, integrity, and regulatory compliance in a fast-paced lab environment.

Qualifications

• Bachelor's degree in Microbiology or a related field.
• 4-6 years of related work experience.
• Proficient computer skills in Microsoft Word, Excel, and Outlook.
• Knowledge of QC principles in pharma, biopharma, and/or biotech manufacturing.
• Strong written and verbal skills.

Responsibilities

• Maintain current industry regulations, guidance documents, standards, best practices and expectations with regards to aseptic manufacturing, environmental control and microbiology testing.
• Lead/serve as a technical expert and participate in projects related to microbiology testing processes, including method development, improvement, validation, sanitization studies, media fill qualification, and troubleshooting.
• Assess process changes for potential impact on environmental monitoring and microbiology testing; author EIRs, LIRs, NCRs and lead CAPA initiatives.
• Support audits by assisting as a team member for tours and provide technical responses as needed.
• Support day-to-day prioritization of routine in-process, stability, and finished product testing.
• Receive incoming samples for testing.
• Prepare reagents and standards used for testing.
• Support operations related to environmental monitoring and monitoring of critical utilities.
• Support bioburden and endotoxin in-process samples, raw materials and finished products.
• Perform growth promotion.
• Serve as a trainer for microbiology technicians and maintain training documentation.
• Maintain stock cultures of organisms used for laboratory testing.
• Prepare isolates for microbial identification.
• Support data entry and data trending of results.
• Comply with applicable GMPs.

Skills

Strong written and verbal skills

Education

Bachelor's degree in Microbiology or related field

Tools

Microsoft Word

Microsoft Excel

Microsoft Outlook

Job description

Description

QC Microbiologist III

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 Microbiologist III supports quality systems as they relate 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 cross-functional interaction at all levels, working within and leading teams to ensure compliance and drive continuous improvement of environmental control and microbiology testing.

The hours for this position are on 1st shift: 8:00 am to 5:00 pm, Monday - Friday.

Non-Negotiable Requirements:

• Bachelor's degree in Microbiology or a related field.
• 4-6 years related work experience.
• Must have proficient computer skills in Microsoft Word, Excel, and Outlook.
• Knowledge of QC principles and procedures in a pharma, biopharma, and/or biotech manufacturing environment.
• Strong written and verbal skills.

Preferred Requirements:

• Experience working in an aseptic manufacturing environment.

Responsibilities Include (but are not limited to):

• Maintain a complete and up-to-date understanding of current industry regulations, guidance documents, standards, best practices and expectations with regards to aseptic manufacturing, environmental control and monitoring, and microbiology testing.
• Lead/Serve as a technical expert and/or actively participates in technical projects pertaining to microbiology testing processes, including but not limited to method development, method improvement, validation activities, sanitization studies, media fill qualification activities, and troubleshooting etc.
• Assess process/procedure changes proposed by others for potential impact on environmental monitoring/microbiology testing processes. Author EIR's, LIR's, NCR's, and lead CAPA and continuous improvement initiatives.
• Support Agency, customer, and vendor audits by assisting as a team member for tours and as needed to assist team in technical responses.
• Support day-to-day prioritization of routine in-process, stability, and finished product testing.
• Receive incoming samples for testing.
• Prepare Reagents and Standards used for testing.
• Support operations related to environmental monitoring and monitoring of critical utilities.
• Support Bioburden and Endotoxin In-Process Samples, Raw Materials and Finished Products
• Perform Growth Promotion.
• Serve as a trainer for tasks performed by Microbiology Technicians, Microbiology I and Microbiology II.
• Maintain all training documentation via current system.
• Maintain stock cultures of organisms used for laboratory testing.
• Prepare isolates for microbial identification.
• Support Data entry of results generated by Laboratory.
• Support Data Trending of results.
• Comply with applicable GMPs.

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.