QA Supervisor - Finishing

Grand River Aseptic Manufacturing, Inc.; Grand Rapids (MI); Vor Ort; USD 65.000 - 90.000; Vollzeit

Benefits dieser Stelle

Benefits day 1

Paid volunteerism

PTO

Wellness time off

Paid holidays

401(k)

Zusammenfassung

Grand River Aseptic Manufacturing (GRAM) seeks a QA Supervisor to lead Quality Systems overseeing Finishing Operations, including inspection, labeling, and packaging. The role collaborates with Operations, Technical Services, Validation, QC, Business and Finance teams to ensure compliance and continuous improvement.

The ideal candidate has a Life Sciences background, 4+ years in QA, and strong knowledge of cGMP, FDA guidelines, and regulatory standards.

Qualifikationen

• Bachelor’s degree in Life Sciences or related field; or 4+ years of related experience.
• 3+ years in a QA Specialist role.
• Thorough understanding of cGMP and FDA guidelines.

Aufgaben

• Supervise Quality Specialists and Technicians across shifts.
• Oversee Finishing operations and batch release processes.
• Review and approve cGMP documentation and risk assessments.
• Provide client support and interact with auditors/regulators.
• Collaborate with Operations, Technical Services, QC, and Finance teams.

Kenntnisse

Leadership

Regulatory knowledge

cGMP expertise

Attention to detail

Ausbildung

Bachelor’s degree in Life Sciences

Tools

Microsoft Word

Microsoft Excel

Outlook

Jobbeschreibung

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.