Aseptic GMP QA Manager - Quality Systems Leader

Grand River Aseptic Manufacturing Inc.; Grand Rapids (MI); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with immediate vesting

Paid volunteer time

Up to 13 days PTO per year

10 paid holidays per year

Job summary

Grand River Aseptic Manufacturing Inc. is seeking a leader in Quality Systems to oversee aseptic manufacturing operations. Ideal candidates will possess a Bachelor's degree in Life Sciences, 8+ years of relevant experience, and 4 years in a management role in a GMP environment.

As part of the team, you will ensure adherence to quality principles and contribute to community initiatives. Benefits include medical, dental, vision insurance, 401(k), generous PTO, and paid volunteerism starting on day one.

Qualifications

• 8+ years related work experience in GMP manufacturing environment.
• 4 years management/leadership experience required.
• Knowledge of quality principles and procedures in pharma or biotech.
• Understanding of cGMP, FDA, and multinational regulatory standards.

Responsibilities

• Provide direction and leadership for quality systems.
• Review and revise cGMP documentation and other quality documents.
• Communicate effectively with management and regulators.
• Make sound decisions about scheduling and resource allocation.
• Lead teams to meet objectives and identify improvement areas.

Skills

Technical writing

Documentation skills

Communication

Decision-making

Management ability

Initiative

Education

Bachelor's degree in Life Sciences or related field

Job description

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:

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

Non-Negotiable 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.

Preferred Requirements:

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

Responsibilities Include (but are not limited to):

• 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.

Full job description available during formal interview process.

Shift: 6:00AM - 6:00PM Friday-Sunday

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!