Senior Microbiologist, Contamination Control — Lead QC

Grand River Aseptic Manufacturing Inc.; Grand Rapids (MI); Sur place; USD 90 000 - 130 000; Plein temps

Avantages offerts par ce poste

Benefits from day 1

Paid volunteer time

104 hours PTO per year

Wellness time off

10 paid holidays

Pay discussed on interview

Résumé du poste

Grand River Aseptic Manufacturing Inc. in Grand Rapids, MI seeks a Sr. Microbiologist, Contamination Control to support quality control and assurance by assisting the microbiology department with investigations and corrective actions.

The role requires a bachelor’s in microbiology or related field with 4–6 years of experience, knowledge of QC/Contamination Control, and proficiency in Word/Excel/Outlook. Preferred candidates have cGMP familiarity and aseptic experience.

Qualifications

• Bachelor’s degree in microbiology, or related field, and 4–6 years' related work experience.
• Knowledge of Quality Control, Contamination Control, and Microbiology principles in pharma/biopharma/biotech manufacturing.
• Proficient computer skills in Microsoft Word, Excel and Outlook.

Responsabilités

• Lead and author investigations for related department NCRs, EIRs, and LIRs.
• Perform training or SOP/TM revisions arising from Action Items/CAPAs.
• Maintain qualifications for routine Micro tasks.
• Support routine tasks including 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.
• Perform bioburden and endotoxin testing on client 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 from environmental monitoring and testing.
• Trend test results.
• Comply with applicable GMPs and GLP practices.

Connaissances

Microbiology principles

Quality control

Contamination control

Regulatory awareness

Formation

Bachelor's degree in microbiology or related field

Outils

MS Office (Word, Excel, Outlook)

Description du poste

Grand River Aseptic Manufacturing Inc. in Grand Rapids, MI seeks a Sr. Microbiologist, Contamination Control to support quality control and assurance by assisting the microbiology department with investigations and corrective actions.

The role requires a bachelor’s in microbiology or related field with 4–6 years of experience, knowledge of QC/Contamination Control, and proficiency in Word/Excel/Outlook. Preferred candidates have cGMP familiarity and aseptic experience.