QA Specialist Aseptic Operations (Weekend Nights)

Grand River Aseptic Manufacturing, Inc. • Grand Rapids, MI

29d • Onsite

About The Position

The Quality Assurance Specialist supports quality systems as they relate to the manufacturing and testing of cGMP drug products. The Quality Assurance Specialist provides oversight and general support for the manufacturing of aseptic processes, deviation and CAPA systems, batch record review, SOP creation and revision, review of quality documents, and supports the Quality Management System.

Requirements

• Bachelor’s degree in Life Sciences or related field, and 2-5 years related work experience. In lieu of a bachelor’s degree, equivalent GMP/related work experience may be considered.
• Ability to complete tasks with accuracy and efficiency.
• Proficient computer skills in Microsoft Word, Excel, and Outlook.

Nice To Haves

• Knowledge of quality assurance principles and procedures in a pharma, biopharma, and/or biotech manufacturing environment.

Responsibilities

• Provide on the floor Quality oversight within the warehouse and manufacturing areas to support compliance with procedures and manufacturing documentation during operations with minimal guidance.
• Establish and maintain good technique with regards to working in classified areas (including gowning qualification).
• Review and approve executed batch records and other associated controlled documents.
• Perform QA review in-process, environmental monitoring test results, and material release for incoming materials.
• Participate in cross functional teams to support quality investigations.
• Perform tasks within the quality systems with an understanding of the correlation between systems, such as the relationship between a deviation and CAPA.

Benefits

• 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.
• Generous off-shift premiums
• 16 hours of paid volunteer time per calendar year
• Full-time employees accrue up to 13 days of time off per calendar year.
• Employees earn 1 hour of time off for every 30 hours worked to use how you choose.
• 10 paid holidays per calendar year with immediate eligibility!

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level