Grand River Aseptic Manufacturing, Inc Hiring for QA Specialist II – Technical Support Job at Grand Rapids, MI Full Time

Quality, Service, Collaboration, Courage. Do you exhibit these values and wish to be around others that do too? Are you interested in making a difference in your community and the world? Are you looking for a place where you can grow and learn in a diverse, community-minded culture? 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:

This position provides technical support to both internal and external projects, including the on-boarding of new clients/client projects, capital expenditures (CAPEX), continuous improvement initiatives, and as required in routine manufacturing operations. This position works closely with Project Managers, Filling and Finishing Operations, Quality Assurance Operations, Analytical Technical Services, Manufacturing Science & Technology, Validation, and QC Analytical and Microbiology departments.

Non-Negotiable Requirements:

• Bachelor’s degree in Life Sciences or a related field and/or a minimum of 3-5 years related work experience.
• Knowledge of QA principles and procedures in a pharma, biopharma, and/or biotech manufacturing environment.
• Thorough understanding of cGMP, FDA guidelines and multinational regulatory standards.
• Proficient computer skills in Microsoft Word, Excel, and Outlook.

Preferred Requirements:

• Experience and expertise in an aseptic environment or manufacturing environment of regulated products.

Responsibilities Include (but are not limited to):

• Provide working knowledge of GMP and regulatory requirements as it relates to performing Quality Assurance review and approval of cGMP documentation in support of both GRAM and client-driven projects, including:
• Standard Operating Procedures
• Raw Material, Component and Finished Product Specifications
• Test Methods
• Master Batch Records
• Risk Assessments including change control assessments
• Validation Documents (master plans, protocols, studies, summary reports, requirements documents, etc.)
• Provide review of executed batch records in relation to initial technical transfer and process performance qualifications.
• Act as a QA representative on project teams to ensure that project deliverables meet all regulatory and industry best practice standards.
• Manage Quality deliverables according to project schedules and ensure tasks assigned are delivered according to project timeline.
• Ensure that project deliverables meet all regulatory and industry best practice standards.
• Understand and is aware of the quality consequences which may occur from the improper performance of assigned job.

Full job description available during formal interview process.

What Sets GRAM Apart from Other Employers:

MEDICAL BENEFITS starting day 1: Blue Cross Blue Shield medical and dental, vision, life insurance, and disability benefits are available to you and your family on your first day of work, with the company paying for 75% 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!

PTO: Full-time employees accrue up to 17 days of time off per calendar year. You choose how to use this time for your vacation, sick, or mental health needs!

PAID HOLIDAYS: We offer 8 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!