QC Microbiologist III

Grand River Aseptic Manufacturing Inc.; Grand Rapids (MI); Hybrid; USD 75,000 - 100,000; Full time

Job summary

Grand River Aseptic Manufacturing (GRAM) in Grand Rapids, MI seeks a QC Microbiologist III to support environmental control in an aseptic processing operation and microbiology testing for customer products and GRAM operations.

Hours are 1st shift: 8:00 am to 5:00 pm, Monday–Friday. Requires a Bachelor’s in Microbiology, 4–6 years experience, proficiency in Word/Excel/Outlook, QC principles in pharma/biotech, and strong written/verbal communication.

Qualifications

• Bachelor’s degree in Microbiology or a related field
• 4-6 years related work experience
• 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

Responsibilities

• Maintain a complete and up-to-date understanding of current industry regulations, guidancedocuments, standards, best practices and expectations with regards to asepticmanufacturing, 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, Microbiologists I and Microbiologists 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

Skills

Strong written and verbalcommunication

Attention to detail

Education

Bachelor's degree in Microbiology

Tools

Microsoft Word

Microsoft Excel

Outlook

Job 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, guidancedocuments, standards, best practices and expectations with regards to asepticmanufacturing, 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, Microbiologists I and Microbiologists 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.

If you meet the required criteria listed above, GRAM welcomes you to apply today!