Sr. Manager QA Finishing Operations & Lot Release

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:

The Senior Manager provides direction and leadership to Grand River Aseptic Manufacturing (GRAM) Quality Systems with oversight of the Quality Assurance Functions supporting Finishing Operations (inspection, labeling and packaging), Incoming Material operations, Technical Support and Finished Product Batch Release. This position works closely with all levels of the Operations (Manufacturing, Finishing, Warehouse), MSAT, Validation, QC (Microbiology and Analytical Chemistry), Supply Chain, Business Development and Finance teams. This is an on-site role.

Non-Negotiable Requirements:

• At least 5 years of prior management/leadership experience required.
• Bachelor's Degree in Life Sciences or a related field and/or a minimum of 10-12 years related work experience.
• A thorough understanding of cGMP, FDA guidelines and multinational regulatory standards is required.
• Knowledge of Quality principles and procedures in a pharma, biopharma, and/or biotech manufacturing environment.
• Proficient computer skills in Microsoft Word, Excel, and Outlook.

Preferred Requirements:

• Experience and expertise in aseptic manufacturing of regulated products is preferred.

Responsibilities Include (but are not limited to):

• Provide leadership to Quality Assurance Managers/Supervisors, QA Specialists and QA Technicians. Responsibilities include hiring, managing, motivating, resource allocation, coaching and mentoring.
• Ensure Quality Assurance support and oversight of the above GRAM Operations across all shifts, including weekend support.
• Review and approval of non-conformance reports, including deviations, laboratory / OOS investigations.
• Oversight and management of Material and Batch Review / Release systems.
• Client support / interaction related to these processes.
• Interface with auditors, including client representatives and regulatory agencies.

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!