QA Specialist III Lot Release (1st Shift)

Description

Agility, Impact, Methodology. Do you exhibit these values and wish to be around others that do too? Do you thrive in fast-paced environments where agility, adaptability, and high standards go hand in hand? Are you driven to make a meaningful impact, whether through your work, your support of others, or your commitment to your community? Are you motivated by a disciplined, science-based approach that ensures consistent excellence, safety, and integrity in everything you do? 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: Support quality systems as they relate to the release of commercial drug lots and Finishing batch record review. These duties include, but are not limited to, the release of drug products, CoC/CoQ Generation, and CoA review and approval. Support and lead continuous improvement efforts to support lot release activities and reflect GRAM Core Values.

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 and expertise in aseptic manufacturing of regulated products with a thorough understanding of cGMP, FDA guidelines and multinational regulatory standards is preferred.

Responsibilities Include (but are not limited to):

• Review and approve controlled documents to support compliant operation of QA Lot Release department and Finishing operations
• Collaborate and communicate with clients and other departments in the research, development, implementation, and support/troubleshooting of new and existing Laboratory Application Systems and electronic batch record systems.
• Perform tasks within the quality systems with a demonstrated understanding of the correlation between systems.
• Revise and monitor the redline system and update documents in MasterControl as needed
• Perform transactions in QAD as required to support finished product release functions
• Perform QA Drug Product Batch Release, CoC Generation, CoA review/approval and associated data entry.
• Provide sound quality and technical inputs to continuous improvement projects to ensure all project-related deliverables are aligned with and delivered accordingly on time.

Full job description available during formal interview process. What Sets GRAM Apart from Other Employers: 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!