Quality Specialist

As a Quality Specialist, you will play a pivotal role in reviewing and evaluating documentation against GMP requirements for the manufacture of drug excipients, such as poloxamer. You will identify gaps, recommend remediation actions, and ensure compliance with GMP standards. This role involves drafting, revising, and managing SOPs, work instructions, and quality records to align with compliance requirements. You will also support training efforts related to new or revised procedures.

• Review and evaluate documentation against GMP requirements for drug excipient manufacturing.
• Report on identified gaps and recommend necessary remediation actions for GMP compliance.
• Draft, revise, and manage SOPs, work instructions, and quality records.
• Support training efforts related to new or revised procedures.
• Monitor progress of remediation activities to ensure delivery of GMP compliant documentation within deadlines for qualification and validation batches.
• Prepare and present status updates and reports to quality management.
• Ensure all remediation activities are completed within the defined timeline and meet FDA expectations.

• Experience leading GMP compliance efforts for drug excipient or API manufacturing.
• Experience with QMS audits for GMP compliance and contributing to audit or quality management teams.
• Experience creating and maintaining remediation activities and quality documentation.
• Bachelor’s degree in Life Sciences, Engineering, or related field.
• Minimum 5 years of experience in pharmaceutical quality management.
• Proven experience with GMP quality audits, inspection readiness, and remediation.
• Strong understanding of GMP quality systems and documentation practices.
• Excellent communication, organizational, and analytical skills.
• Ability to work independently in a fast-paced, deadline-driven environment.
• Familiarity with electronic quality management systems (eQMS).

• Comfortable working onsite with an internal quality management expert in a collaborative environment.
• Ability to take the lead on quality gap assessments and work with the client QM to develop remediation plans.
• Willingness to track work completed on a weekly basis and monitor deliverables.
• Ability to organize schedule and work independently.

This position requires onsite work in a collaborative environment where you will work closely with an internal quality management expert. You will take the lead on quality gap assessments and collaborate with the client QM to develop remediation plans. The role requires tracking work completed on a weekly basis and monitoring deliverables in a fast-paced, deadline-driven setting.

This is a Contract position based out of Wyandotte, MI.

The pay range for this position is $55.00 - $65.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

This is a fully onsite position in Wyandotte,MI.

This position is anticipated to close on Apr 3, 2026.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000 extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.

Salary : $55 - $65