QA Specialist III - OTS

Socket.dev; Grand Rapids (MI); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical benefits starting day 1

401(k) immediate vesting

Paid volunteerism

PTO 17 days per year

Wellness time off

Paid holidays

Job summary

Grand River Aseptic Manufacturing (GRAM) seeks a Quality Assurance professional to oversee GMP investigations for aseptic filling operations. You will review deviations, CAPAs, and root-cause analyses to ensure scientific rigor and regulatory compliance.

Ideal candidates have 8+ years in pharma quality and strong technical writing, with client-facing experience to close NCRs on time. Comprehensive benefits and a collaborative, safety-first culture await.

Qualifications

• Bachelor’s degree in Life Sciences or related field (or 8+ years related experience).
• 8+ years of related work experience in pharma/biopharma/biotech quality.
• 3+ years of technical writing authoring and owning quality investigations.
• Knowledge of quality principles, cGMP, FDA guidelines, and regulatory standards.
• Client-facing experience, including leading meetings to resolve NCRs.

Responsibilities

• Perform QA review and technical oversight of GMP investigations in aseptic filling operations.
• Review deviation investigations, CAPAs, action items, and root-cause analyses.
• Ensure investigations are scientifically sound, well-documented, and compliant.
• Lead cross-functional meetings to drive root-cause analysis and timely NCR closure.
• Initiate site quality metrics and non-conformance trend reviews daily to monthly.
• Lead training and mentorship for the Quality team on writing and evaluating NCR investigations.
• Support agency, customer and vendor audits as needed.
• Exhibit professional behavior reflecting GRAM policies and practices.

Skills

Quality Assurance

Technical writing

Cross-functional collaboration

Client-facing communication

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!