QA Specialist II - Supplier Quality

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:

Ensuring that materials and services provided by GRAM's suppliers meet all regulatory, quality, and company standards. This role supports supplier qualification, incoming material inspection, and resolution of supplier-related issues under the guidance of other staff members. The Supplier Quality Specialist plays a critical role in mitigating risks, ensuring supply chain compliance, and promoting continuous improvement in supplier processes.

Non-Negotiable Requirements:

• Bachelor's degree in technical field.
• A minimum of 2 years' experience in a regulated environment.
• Working knowledge of cGMP, ISO, ICH, CFR, FDA and EU regulations.
• Experience with root cause analysis tools (e.g.,5 Whys, Fishbone).

Responsibilities Include (but are not limited to):

• Develop and implement supplier quality programs and procedures.
• Conduct routine supplier audits and risk assessments.
• Lead investigations for supplier non-conformances.
• Manage supplier corrective and preventive actions (CAPAs).
• Monitor supplier performance metrics and trends.
• Evaluate and approve supplier changes or requalifications.
• Collaborate with cross-functional teams on material issues.
• Review and provide final disposition of materials.

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!