QA Specialist II Incoming Materials

QA Specialist II – Incoming Materials

Agility, Impact, Methodology. 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:

The QA Specialist II – Incoming Materials position supports quality systems as they relate to the release of incoming materials in support of manufacturing and testing of cGMP drug products.

Non-Negotiable Requirements:

• Undergraduate Degree in Life Sciences or related field.
• 2-5 years related work experience.
• Ability to interpret and relate quality standards for implementation and review.
• Must have proficient computer skills in Microsoft Word, Excel and Outlook.

Preferred Requirements:

• In lieu of a bachelor's degree, equivalent GMP/related work experience may be considered.

Responsibilities Include (but are not limited to):

• Perform the quality release of incoming materials, including APIs/RMs/Components.
• Support Technicians with component AQL inspections.
• Perform material transactions in the Inventory Management System.
• Support Weigh & Dispense and Warehouse operations.
• Manage specific QA systems, including LIRs/CLIRs, SQIRs, CAPAs and Deviations (VIIs) associated with incoming materials.
• Lead and or facilitate cross functional teams and investigations to drive the desired outcomes.
• Provide review and input on Supplier Quality Agreements and other quality related documents, including SOP creation and revision.
• Review and approve associated changes to incoming materials, including batch records, specifications, methods, change controls, etc.
• Perform assessments of new components for defect criteria alignment.
• Work cross functionally to support quality investigations.

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!