QA Manager - Patterson North Operations

Grand River Aseptic Manufacturing, Inc. • Grand Rapids, MI

9d

About The Position

Provide direction and leadership of the Grand River Aseptic Manufacturing (GRAM) Quality Systems with oversight of Aseptic Manufacturing operations.

Requirements

• Bachelor’s degree in Life Sciences or a related field and/or a minimum of 8+ years related work experience
• 4 years of prior management / leadership experience required in a GMP manufacturing environment.
• Knowledge of Quality principles and procedures in a pharma, biopharma, and/or biotech manufacturing environment.
• A thorough understanding of cGMP, FDA guidelines and multinational regulatory standards.

Nice To Haves

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

Responsibilities

• Strong technical writing and documentation skills, with the ability to clearly author, review, and revise cGMP documentation, NCR investigations, SOPs, and other quality documents in a highly regulated aseptic manufacturing environment.
• Ability to interpret and relate Quality standards for implementation and review.
• Ability to portray an appropriate level of integrity and professionalism at all times.
• Ability to communicate effectively with management, staff, regulators and client representatives, in both written and verbal forms.
• Ability to complete tasks accurately and according to established timelines.
• Demonstrated management ability with a proven track record of leading teams to meet objectives.
• Ability to make sound decisions about scheduling, allocation of resources and managing priorities.
• Demonstrated high level of initiative with the ability to work independently, identify areas of improvement, and proactively drive solutions in a fast paced aseptic manufacturing environment.

Benefits

• 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.
• Generous off-shift premiums
• 16 hours of paid volunteer time per calendar year
• Full-time employees accrue up to 13 days of time off per calendar year.
• Employees earn 1 hour of time off for every 30 hours worked to use how you choose.
• 10 paid holidays per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Manager