Sr. Microbiologist, Contamination Control

Grand River Aseptic Manufacturing Inc.; Grand Rapids (MI); Presencial; USD 90.000 - 130.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Benefits from day 1

Paid volunteer time

104 hours PTO per year

Wellness time off

10 paid holidays

Pay discussed on interview

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Microbiology principles

Quality control

Contamination control

Regulatory awareness

Educación

Bachelor's degree in microbiology or related field

Herramientas

MS Office (Word, Excel, Outlook)

Descripción del empleo

Description

Sr. Microbiologist, Contamination Control

Overview of this Position:

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

Non-Negotiable 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.

Preferred Requirements:

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

Responsibilities Include (but are not limited to):

• 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.

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.