QA Specialist III - OTS

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

3d • Onsite

About The Position

Perform Quality Assurance review and technical oversight of GMP investigations across multiproduct Aseptic Filling CDMO operations. Activities include review of deviation investigations, CAPAs, action items, and associated root cause analyses to ensure investigations are scientifically sound, adequately documented, and compliant with applicable GMP requirements.

Requirements

• Bachelor’s degree in Life Sciences or a related field and/or a minimum of 8+ years related work experience
• 3 years or more years of technical writing experience include experience with owning quality investigations, writing root cause analysis, developing CAPA/Action Items, and demonstrating ability to meet on time non-conformance metrics.
• 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.
• Client-facing experience, including leading and facilitating meetings with respective clients to effectively close NCRs on-time contributing to meeting customer service metrics.

Nice To Haves

• Previous experience in a CMO and sterile filling, manufacturing, and/or fill finish environment is preferred.

Responsibilities

• Exhibit complex conflict resolution and problem-solving skills in a cross functional setting.
• Work closely with respective team members from Operations Technical Support, Manufacturing, Engineering, Maintenance, and Project Management to ensure all documentation is gathered in expeditious manner for timely completion on non-conformance investigations.
• Ensure appropriate risk assessments, root cause, preventative, and corrective action tools are utilized for all non-conformance investigations.
• Lead cross-functional meetings and discussions to drive effective root cause analysis and ensure timely completion of non-conformance investigations.
• Initiate daily, weekly, and monthly site quality metrics and non-conformance trend reviews.
• Lead comprehensive training and mentorship programs for the Quality team, equipping members with the skills needed to write, evaluate, and review rigorous non-conformance investigations.
• Perform Quality Assurance review and approval of cGMP documentation in support of continuous improvements.
• Support Agency, customer and vendor audits as needed.
• Exhibit professional and respectful behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.

Benefits

• 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.
• 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!
• Full-time employees accrue up to 17 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: We offer all employees one (1) paid day of Wellness Time Off (WTO) per quarter to invest in self-care, take some downtime, or whatever you choose.
• 10 paid holidays per calendar year with immediate eligibility!

What This Job Offers

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