QA Specialist I - Lot Release

Description

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:

The QA Specialist in the Lot Release department supports the quality systems as they relate to the manufacturing and testing of cGMP drug products. Provides quality support of GDP for terminal sterilization, visual inspection, labeling and packaging Operations of parenteral drugs. Provides oversight and general support for deviation and CAPA systems, batch record review, SOP creation and revision, and review of quality documents, such as COAs.

Non-Negotiable Requirements:

• Bachelor's degree in Life Sciences or related field, and 1-2 years related work experience. In lieu of a bachelor's degree, equivalent GMP/related work experience may be considered.
• Knowledge of QA principles and procedures in a pharma, biopharma, and/or biotech manufacturing environment.
• Must have proficient computer skills in Microsoft Word, Excel, and Outlook.

Preferred Requirements

• Experience working in a pharmaceutical or other regulated environment.

Responsibilities Include (but are not limited to):

• Verify compliance with terminal sterilization, visual inspection, labeling and packaging operations documentation during operations.
• Review executed batch records and other associated controlled documents.
• Perform QA review and approval of stability and finished products testing certificates of analysis.
• Understand and be able to perform job responsibilities in compliance with cGMPs, company standard operating procedures, and industry best practices.
• Participate in deviation investigation teams to support quality investigations (NCRs, LIRs etc.).

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 13 days of time off per calendar year. You choose how to use this time for your vacation, sick, or mental health needs!

WELLNESS TIME OFF: Employees earn 1 hour of time off for every 30 hours worked to use how you choose.

PAID HOLIDAYS: We offer 10 paid holidays per calendar year with immediate eligibility!

PAY: Depends on Experience and is discussed during the interview process.