Job Title: QA Engineer - Compliance Specialist

Job Description

This role is pivotal in ensuring compliance with sight quality records, adhering to stringent requirements and regulations. The position involves participating in site inspection readiness activities, conducting internal audits of Quality systems and GMP functions, supporting client audits, and implementing corrective actions. The role guarantees overall compliance with FDA, EMA, and other cGMP regulations.

Responsibilities

• Ensure compliance with FDA, EMA, and other cGMP regulations and client requirements.
• Oversee Site Quality Records to ensure timely completion and adherence to requirements, including CAPA, audits, and change control.
• Lead and participate in site internal audits, including executing, approving responses, and supervising remediation activities.
• Support or lead client audits or inspections.
• Approve corrective action plans and effectiveness checks for Quality System CAPAs.
• Author, review, or approve documents within eDMS as needed.
• Participate in inspection readiness tasks and regulatory inspections.
• Provide expertise on current cGMP requirements and trends to support quality/compliance matters at the site.
• Train and mentor junior staff members.

Essential Skills

• Quality assurance and quality management system expertise.
• Experience in a GMP or regulated industry.
• Proficiency in Quality Systems including change control, deviations, documentation management, and training systems.
• Experience with electronic Quality and Training Management Systems, quality control, and inspection.
• In-depth knowledge of FDA/EMA regulatory requirements.
• Strong understanding of Quality Management Systems.
• Previous experience with hosting client audits and regulatory inspections.

Additional Skills & Qualifications

• Bachelor’s degree in a scientific field such as Life Sciences or Biotechnology.
• 5+ years of experience within a GMP Environment, preferably pharmaceutical.
• Confirmed experience within Quality Assurance or Compliance.
• At least 2 years of experience in conducting internal audits.

Work Environment

Join a dynamic team engaged in large-scale biological and chemistry pharmaceutical operations. The work environment is innovative, with a culture dedicated to impactful work and customer-centric values. The organization supports making biologics for pharmaceuticals addressing major health issues. Employees are empowered to realize their potential in a fast-growing, global organization that values passion and unique contributions. The company offers resources and opportunities for career growth while making a difference in the world.

Pay and Benefits

The pay range for this position is $38.00 - $50.00/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)

Workplace Type

This is a fully onsite position in Saint Louis,MO.

Application Deadline

This position is anticipated to close on Jul 2, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.