Grand River Aseptic Manufacturing

QC Microbiologist II

Grand River Aseptic Manufacturing  •  Grand Rapids, MI (Onsite)  •  14 hours ago
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Job Description

QC Microbiologist II

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!

of this Position:

The QC Microbiologist II supports quality control and assurance by assisting the microbiology department with environmental monitoring, water testing, and client specific testing.

The hours for this position are on 1st shift: 6:00 am to 3:00 pm, Monday - Friday.

Non-Negotiable Requirements:

  • Bachelor’s degree in Microbiology or a related field.
  • 2-4 years related work experience.
  • Must have proficient computer skills in Microsoft Word, Excel, and Outlook.
  • Knowledge of quality principles and procedures in a pharma, biopharma, and/or biotech manufacturing environment.
  • Strong written and verbal skills.

Preferred Requirements:

  • Experience working in an aseptic manufacturing environment.

Responsibilities Include (but are not limited to):

  • Perform sampling and testing of critical utilities (water, pure steam, compressed gasses) to support manufacturing activities.
  • Perform Environmental Monitoring of isolator and supporting areas. Including sampling and reading of media plates.
  • Perform bioburden and endotoxin testing on client specific raw materials, in-process samples, and finished products.
  • Data entry and trending of microbiological testing results
  • Serve as a trainer for tasks performed by Quality Control Microbiology Technicians and Microbiologists.
  • Maintain laboratory equipment – including coordination of calibration and preventative maintenance.
  • Perform daily, weekly, and monthly lab maintenance and supply ordering/stocking.
  • Receive and perform testing on various samples to support validation studies and cleaning verification.
  • Perform general microbiological laboratory tasks including but not limited to; preparation of reagents and standards, performance of growth promotion on media, maintenance of stock organism culture, and preparation isolates for microbial identification.
  • Author Environmental Investigation Reports and Laboratory Investigation Reports.
  • Revise Test Methods and Standard Operating Procedures.
  • Comply with applicable GMPs.
  • Maintain good aseptic conduct in laboratory and cleanroom spaces.
  • Maintain laboratory logbooks and other forms to document proper GMP testing.
  • Perform all job responsibilities in compliance with applicable regulations, standard operating procedures, and industry practice.

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!

Grand River Aseptic Manufacturing

About Grand River Aseptic Manufacturing

Grand River Aseptic Manufacturing (GRAM) is a leading contract development and manufacturing organization (CDMO) specializing in sterile injectable fill-and-finish services for liquid and lyophilized vials, syringes, and cartridges. We are committed to advancing patient care by providing our clients with the experience, technology, and quality record necessary for effective clinical trials and successful commercialization.

GRAM adds value for our clients through strategic partnerships with innovators in drug delivery devices, offering tailored solutions designed for autoinjectors and on-body delivery systems. Our emphasis on collaboration allows us to speed up the delivery of innovative therapies, ensuring that our clients' products reach the market and benefit patients into the future.

Industry
Chemicals & Materials
Company Size
201-500 employees
Headquarters
Grand Rapids, Michigan
Year Founded
2011
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