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!

NON-NEGOTIABLE REQUIREMENTS:

• Bachelor’s degree in Life Sciences or a related field.
• Minimum of 5 years related work experience.
• Experience and expertise in aseptic manufacturing of regulated products with a thorough understanding of cGMP, FDA guidelines and multinational regulatory standards.
• Knowledge of general laboratory test methods.
• Knowledge of QA/QC principles and procedures in a pharma, biopharma, and/or biotech manufacturing environment.

PREFERRED REQUIREMENTS:

• Experience in operation of validated 21 CFR Part 11 compliant computer systems. Prior experience with LabVantage, or similar Laboratory Information Management System (LIMS).
• Knowledge of environmental monitoring programs.
• Experience in computer system change management, specifically related to master data management.

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

• Support Quality Control in the build and/or revision, review, and approval of LIMS master data, including but not limited to products, specifications, and methods, per LIMS procedures.
• LIMS end user subject matter expert (SME).
• Assist the LIMS Manager in supporting end user technical and data entry issues.
• Provide end user on the job training (OJT) for laboratory and production employees where required. Participate in LIMS training development and implementation.
• Assist in revising user procedures and documentation for system enhancements, changes to user requirements, or updates based on business needs.
• Work closely with lab operations to understand existing workflows, challenges, and opportunities for improvement and make recommendations to management.
• Support Laboratory Application Systems Administrator in the Administration of LabVantage LIMS.
• Assist in managing business needs change controls and execute action items for LIMS.
  Full job description available during formal interview process.