QA Specialist I/II - Technical Support

Grand River Aseptic Manufacturing, Inc. offers a collaborative, quality driven environment onsite in Grand Rapids, MI. In the QA Specialist I/II - Technical Support role, you will provide quality assurance support for internal and external projects, including onboarding new clients and projects, CAPEX initiatives, and continuous improvement efforts, all while ensuring regulatory compliance and timely deliverables across GRAM departments.

Benefits and culture

• Healthcare from day 1: Medical, prescription, dental, vision, life insurance, and disability benefits are available from day one with the company contributing to costs.
• 401(k) with immediate vesting of contributions.
• 16 hours of paid volunteer time per calendar year.
• PTO: 13 days per calendar year.
• Wellness time off: 1 hour for every 30 hours worked.
• 10 paid holidays per calendar year.

Why GRAM stands apart

• 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.

Responsibilities

• Provide working knowledge of GMP and regulatory requirements as it relates to performing Quality Assurance review and approval of cGMP documentation in support of GRAM and client driven projects including Standard Operating Procedures; Test Methods; Raw Material, Component, and Finished Product Specifications; Risk Assessments including change control assessments; Master Batch Records; Validation Documents.
• Provide review of executed batch records in relation to initial technical transfer and process performance qualifications.
• Support current clients and onboarding of new client projects.
• 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.
• QA representative on project teams to ensure that project deliverables meet all regulatory and industry best practice standards as well as internal deadlines.
• Participate in deviation investigation teams to support quality investigations (NCR, LIR, SQIR, etc.).

Requirements

• Bachelor’s degree in Life Sciences or related field and/or minimum experience levels: Specialist I requires 1-3 years; Specialist II 3-5 years; Specialist III 5-7 years; Sr. Specialist 7+ years.
• Experience and expertise in QA principles and procedures within pharma, biopharma, and/or biotech manufacturing, or a regulated manufacturing environment, with thorough understanding of cGMP, FDA guidelines, and multinational regulatory standards.
• Proficient computer skills in Microsoft Word, Excel, and Outlook.

Technologies

• Microsoft Word
• Microsoft Excel
• Microsoft Outlook

Compensation: Depends on experience and is discussed during the interview process.