Job Title: Senior QA Specialist

Job Description

The Senior Quality Assurance Specialist – Quality Systems, supports all quality system elements to assure compliance with FDA cGMP and other quality standards. The primary responsibilities include regulatory review, annual product review, supplier quality, and external auditing.

Responsibilities

• Provide quality oversight for regulatory compliance changes to Master Control System Records (MCSR's) including post-market changes, submissions, and change controls.

• Conduct final reviews of Annual Product Review (APR) before submission.

• Oversee external and supplier quality functions, including qualifying new suppliers, auditing new and existing suppliers, and maintaining compliance for quality agreements.

• Support the Change Control Process specifically for supplier changes.

• Support the Supplier Qualification Program.

• Update the Approved Vendor/Supplier list.

• Manage external CMO partnerships for compliance.

• Perform internal and external audits as per annual audit schedules.

• Participate in other Quality Systems responsibilities, including tracking and trending of quality data, training, and supporting site data integrity requirements.

• Provide metrics for the Quality Review Board, as requested.

• Provide support during HACCP, FDA, and other inspections.

Essential Skills

• 5+ years of experience in a FDA regulated pharmaceutical facility.

• 5+ years of experience in Quality Assurance / Quality Systems.

• Experience with regulatory review and at least one of the primary areas of responsibility (external/supplier quality, APR review, auditing/review, change control review, quality metrics).

• Proficient in the use of MS Office tools (Word, Excel, Outlook).

• Excellent attention to detail, time management, team participation, and organizational skills.

• Ability to follow standard operating procedures and safety documents.

• Good verbal, written, and electronic communication skills.

• Ability to collaborate with other departments.

Additional Skills & Qualifications

• Bachelor’s degree strongly preferred; Degree in Biology, Chemistry, or related field of study preferred.

Work Environment

The position follows a Monday to Friday, 8:00 AM to 4:30 PM schedule with some variation. This is an onsite position in a newer office building that is connected to manufacturing. The team values communication, customer focus, integrity, safety & compliance, collaboration, and achieving results. The work environment is respectful and the team is composed of good, supportive people. This role offers opportunities for full-time employment at the end of the assignment, which includes 40 hours of PTO and 6 paid holidays. Excellent benefits are available upon conversion and the role provides high visibility and opportunities to learn multiple areas of quality systems.

Pay and Benefits

The pay range for this position is $33.65 - $38.46/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 St. Louis,MO.

Application Deadline

This position is anticipated to close on Mar 30, 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.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are 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

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 process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.