QA Supervisor - Finishing

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:

The QA Supervisor provides direction and leadership to the Grand River Aseptic Manufacturing (GRAM) Quality Systems with oversight Finishing Operations (Inspection, Labeling, Packaging). This position works closely with all levels of the Operations, Technical Services, Validation, QC (Microbiology and Analytical Chemistry), Business and Finance teams.

Non-Negotiable Requirements:

• Bachelor’s degree in Life Sciences or a related field and/or a minimum of 4+ years related work experience.
• At least 3 years prior experience in a QA Specialist role.
• A thorough understanding of cGMP, FDA guidelines and multinational regulatory standards.
• Must have proficient computer skills in Microsoft Word, Excel, and Outlook.

Preferred Requirements:

• Prior leadership experience. 
• Prior experience interacting with regulatory authorities.
• Experience and expertise in aseptic manufacturing of regulated products.

Responsibilities Include (but are not limited to):

• Provide supervision to Quality Specialists and Quality Technicians of various levels. Responsibilities include managing, motivating, coaching and mentoring.
• Ensure Quality support and oversight of Finishing operations across all shifts, including occasional weekend support.
• Oversight and management of the batch record review and final release processes.
• Client support / interaction related to these processes.
• Interface with auditors, including client representatives and regulatory agencies.
• Perform Quality Assurance review and approval of cGMP documentation in support of continuous improvements, including Procedures; Test Methods; Master Batch Records; Risk Assessment Reports

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.