Sr. Microbiologist, Contamination Control

Grand River Aseptic Manufacturing, Inc. • Grand Rapids, MI

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About The Position

The Sr. Microbiologist, Contamination Control supports quality control and assurance by assisting the microbiology department with investigations and corrective actions.

Requirements

• Bachelor’s degree in microbiology, or a related field, and 4-6 years’ related work experience.
• Knowledge of Quality Control, Contamination Control, and Microbiology principles and procedures in a pharma, biopharma, and/or biotech manufacturing environment.
• Must have proficient computer skills in Microsoft Word, Excel and Outlook.

Nice To Haves

• A thorough understanding of cGMP, FDA guidelines and multinational regulatory standards.
• Aseptic experience preferred.

Responsibilities

• Lead and author investigations for related department NCRs, EIRs, and LIRs.
• Perform any training or SOP/TM revisions that result from Action Items/CAPAs.
• Maintain qualifications for routine Micro tasks.
• Support routine tasks as needed including, but not limited to, water sampling, environmental monitoring, and compressed gas sampling.
• Serve as secondary trainer for tasks performed by Microbiology Technicians and Microbiologist I.
• Author quarterly and annual trend reports for all GRAM facilities and ensure completion.
• Perform bioburden and endotoxin testing on client specific raw materials, in-process samples, and finished products.
• Perform testing on biological indicators to support Validation studies.
• Perform growth promotion on media.
• Maintain stock cultures of organisms used for laboratory testing.
• Prepare isolates for microbial identification.
• Read plates generated from environmental monitoring and laboratory testing.
• Trend test results.
• Comply with applicable GMPs.
• Maintain good practices with regards to processes and/or internal conditions leading to an aseptic environment.
• Maintain laboratory logbooks and other forms to document proper GLP testing.
• Perform all job responsibilities in compliance with applicable regulations, standard operating procedures, and industry practice.
• Open to a flexible and fluid work environment.

Benefits

• 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.
• Generous off-shift premiums!
• 16 hours of paid volunteer time per calendar year!
• Full-time employees accrue up to 104 hours of paid time off per calendar year, with this amount being prorated your first year.
• Employees earn 1 hour of wellness time off for every 30 hours worked, to use how you choose.
• 10 paid holidays per calendar year with immediate eligibility!

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level