QA Supervisor (Aseptic Operations) - 2nd shift

Davita Inc.; Grand Rapids (MI); On-site; USD 80,000 - 120,000; Full time

Job summary

A leading company in the healthcare sector is looking for a Quality Systems Director to lead and mentor a team in ensuring quality compliance within aseptic manufacturing processes. The ideal candidate will have extensive experience in Quality Assurance and a solid understanding of regulatory standards, contributing to quality improvements and operational excellence.

Benefits

Medical benefits starting Day 1

16 hours of paid volunteer time annually

Up to 13 days of paid time off per year

Wellness time off

10 paid holidays per year

Qualifications

• At least 3 years in a QA Specialist or related role.
• Thorough understanding of cGMP and FDA guidelines.
• Completion of a bachelor's degree or 4+ years of relevant experience.

Responsibilities

• Manage and lead Quality Specialists, overseeing Quality support for operations.
• Review non-conformance reports and assess deviations.
• Provide QA input for change control and documentation approval.

Skills

Leadership

Quality Assurance

Regulatory Compliance

Education

Bachelor's degree in Life Sciences

Job description

Description

Quality, Service, Collaboration, Courage. Do you exhibit these values and wish to be around others that do too? Are you interested in making a difference in your community and the world? Are you looking for a place where you can grow and learn in a diverse, community-minded culture? 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:

Provides direction and leadership to the Grand River Aseptic Manufacturing (GRAM) Quality Systems with oversight of Aseptic Manufacturing (formulation, filling) operations. This position works closely with all levels of the Operations, Manufacturing Science & Technology, Validation, QC (Microbiology and Analytical Chemistry), and Project Management teams.

Non-Negotiable Requirements:

• At least 3 years prior experience in a QA Specialist or related role.
• A thorough understanding of cGMP, FDA guidelines and multinational regulatory standards.
• Completion of a bachelor's degree in Life Sciences or a related field and/or a minimum of 4+ years related work experience.

Preferred Requirements

• Prior leadership experience.
• Knowledge of Quality Assurance principles and procedures in a pharma, biopharma, and/or biotech manufacturing environment.
• Experience and expertise in aseptic manufacturing of regulated products.
• Prior experience interacting with regulatory authorities.

Responsibilities Include (but are not limited to):

• Provide supervision to Quality Specialists of various levels. Responsibilities include managing, motivating, coaching and mentoring.
• Ensure Quality support and oversight of Aseptic Operations across all shifts, including weekend support.
• Oversight and management of the batch record review processes.
• Review and assessment of non-conformance reports, including deviations, laboratory/OOS investigations and environmental investigations.
• Provide sound quality input to assigned change control assessments.
• 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:

MEDICAL BENEFITS starting day 1: Blue Cross Blue Shield medical and dental, vision, life insurance, and disability benefits are available to you and your family on your first day of work, with the company paying for 75% 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!