Sr. Microbiologist, Contamination Control

Description
Sr. Microbiologist, Contamination Control

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 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.

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