QA Specialist III - OTS

Grand River Aseptic Manufacturing Inc.; Grand Rapids, Northern (MI, KY); Hybrid; USD 100,000 - 140,000; Full time

Benefits offered by this job

Medical benefits from day 1

Paid volunteer time

Paid time off (PTO)

Wellness time off

Paid holidays

Shift differential

401(k) immediate vesting

Job summary

Grand River Aseptic Manufacturing Inc. seeks a senior Quality Assurance professional to provide review and technical oversight of GMP investigations across aseptic filling operations.

You will own deviation investigations, CAPAs, and root cause analyses to ensure scientific rigor and regulatory compliance. The role requires substantial experience in pharma/biopharma quality, leadership in cross-functional settings, and strong client-facing skills to close NCRs on time while supporting audits and

Qualifications

• Bachelor's degree in Life Sciences or related field with 8+ years of related work experience.
• 3+ years of technical writing experience including ownership of quality investigations.
• Knowledge of Quality principles, cGMP, FDA guidelines, and multinational regulatory standards.
• Client-facing experience leading meetings to effectively close NCRs and support metrics.

Responsibilities

• Perform QA review and technical oversight of GMP investigations across multiproduct aseptic filling CDMO operations.
• Review deviation investigations, CAPAs, action items, and root cause analyses for scientific adequacy and compliance.
• Lead cross-functional meetings to drive root cause analysis and timely non-conformance closures.
• Initiate and monitor site quality metrics and non-conformance trend reviews.
• Provide training and mentorship to the Quality team on conducting rigorous investigations.
• Support agency, customer, and vendor audits as needed.

Skills

Technical Writing

Quality Assurance

cGMP

Regulatory Knowledge

Client Facing

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:

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.

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.

Responsibilities Include (but are not limited to):

• 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.

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 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.
• PAID HOLIDAYS: We offer 10 paid holidays per calendar year with immediate eligibility!
• PAY: Depends on Experience and is discussed during the interview process. Shift differential available for second and third shift!