QA Specialist Lot Release ; 2nd Shift

Overview

Support the quality systems as they relate to the manufacturing and testing of cGMP drug products. Provide quality support of GDP for terminal sterilization, visual inspection, labeling and packaging Operations of parenteral drugs. Provide oversight and general support for deviation and CAPA systems, batch record review, SOP creation and revision, and review of quality documents, such as COAs.

• 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.

• Experience working in a pharmaceutical or other regulated environment.

• 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.).
• Creative and open-minded individual who fosters an environment in which sharing of ideas is encouraged.
• Demonstrates an understanding of the decision-making process and begin to build confidence in decision making ability.

Full job description available during formal interview process.

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!

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.

If you meet the required criteria listed above, GRAM welcomes you to apply today!