QC Microbiology Supervisor

Grand River Aseptic Manufacturing Inc.; Grand Rapids (MI); Hybrid; USD 110,000 - 135,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) plan with company match

Paid volunteer time

PTO + WTO

Paid holidays

Job summary

Grand River Aseptic Manufacturing Inc. is seeking a QC Microbiology Supervisor to lead environmental control and microbiology testing within an aseptic processing operation.

You will collaborate cross-functionally to ensure compliant and continuous improvement in microbiology testing and environmental monitoring. The role requires a Bachelor’s in biology or related field, at least 5 years in a microbiology lab, and leadership experience.

Qualifications

• Bachelor's degree in biology or related discipline required.
• Minimum 5 years' experience in a Microbiology lab supporting aseptic manufacturing.
• Knowledge of QC principles in pharma/biotech environments.
• Proficient in MS Word, Excel and Outlook.

Responsibilities

• Manage day-to-day prioritization of routine, in-process, stability and finished product testing.
• Oversee environmental monitoring and monitoring of critical utilities.
• Lead training of new employees and maintain training documentation.
• Support EIR system and assist in CAPAs, NCRs, and laboratory investigations.
• Oversee equipment use and calibration logs.
• Maintain aseptic technique and cleanroom practices.
• Author or revise internal test methods and SOPs.
• Review environmental monitoring data and trend reports.
• Ensure complete and accurate documentation across processes and tests.
• Coordinate with contract labs and subject-matter experts.
• Assist in vendor audits and client/regulatory audits as microbiology SME.

Skills

Leadership

Cross-functional teamwork

Documentation & training

Education

Bachelor's degree in biology

Tools

Microsoft Word

Microsoft Excel

Outlook

Job description

QC Microbiology Supervisor

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, of dedicated individuals improving lives every day!

Overview of this Position:

The QC Supervisor - Microbiology supports and manages 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 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 biology and/or other related discipline (e.g. Biochemistry, Biotechnology).
• Minimum of 5 years' experience in a Microbiology laboratory supporting an aseptic manufacturing process.
• Knowledge of quality control principles and procedures in a pharma, biopharma, and/or biotech manufacturing environment.
• Proficient computer skills in Microsoft Word, Excel, and Outlook.

Preferred Requirements:

• Previous experience with sterility testing is preferred.
• 1 year of prior leadership experience, at minimum, preferred.

Responsibilities Include (but are not limited to):

• Manage day to day prioritization of routine, in-process, stability and finished product testing.
• Manage day to day support of operations related to environmental monitoring and monitoring of critical utilities.
• Lead training of all new employees and maintain all training documentation via current system.
• Support the EIR system and assist in any related Laboratory Investigations, CAPA's, or NCR's.
• Oversight of all equipment use and equipment calibration logs.
• Establish and maintain good technique with regards to working in an aseptic environment.
• Independently author or revise internal test methods and standard operating procedures.
• Review EM trending data, quarterly, and annual summary reports.
• Review process and testing documentation as needed to ensure complete and accurate records are maintained.
• Assesses process/procedure changes proposed by others for potential impact on environmental monitoring/microbiology testing processes.
• Participate in cross-functional meetings and training sessions with manufacturing operations.
• Coordinate with contract testing laboratories and experts as needed.
• Assist in the conduct of vendor audits as a microbiology subject matter expert, as needed.
• Participate in client and regulatory audits as a microbiology subject matter expert, prepares documents for review and speaks to GRAM processes and procedures to answer auditor questions.

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.