Jobs at Grand River Aseptic Manufacturing

Grand River Aseptic Manufacturing (GRAM) is seeking a QA Specialist III (Operations Technical Support, 1st Shift). The role performs 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.

• 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.

Non-Negotiable 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.

Preferred Requirements:

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