Quality Assurance Specialist

Job Title:

Quality Assurance Specialist I

The Quality Assurance (QA) Specialist I is responsible for ensuring that all products manufactured meet the highest quality standards. This role requires a fundamental knowledge of the principles and concepts of cGMPs in pharmaceutical manufacturing and site production processes. The position ensures adherence to regulatory expectations and GxP. The QA Specialist I will oversee manufacturing processes, including formulation, equipment and commodity preparation, aseptic services, and warehouse processes.

Collaboration with cross-functional business groups and management is essential.

• Perform real-time batch record reviews on the production floor to prevent deviations and facilitate real-time corrections.
• Conduct full reviews post-manufacturing and manage corrections to remediate deviations prior to product release.
• Complete periodic checks of auxiliary manufacturing documentation such as production logbooks, forms, and tickets.
• Perform daily and weekly walkthroughs of production and warehouse areas, upscale identified observations, and track the closure of action items.
• Participate in Method 1 meetings to provide quality oversight and support in identifying true root causes and associated CAPAs for manufacturing deviations.
• Utilize systems related to QA activities, including eQMS, Trackwise, RDOCS, and Batch Tracker.
• Use SAP for placing and removing product holds.
• Support on-site regulatory inspections and internal audits, including serving as an audit scribe and preparing pre-audit activities.
• Support Continuous Improvement initiatives to enhance safety and processes and successfully utilize IMEx tools.

• Strong reading comprehension.
• 1–2+ years of GMP experience required.
• Understanding of batch records and key elements, including ALCOA principles and Data Integrity concepts.

• Experience with operations documentation or direct batch record experience.
• Exposure to shop floor quality processes.

This position requires on-site work in containment areas with scrub protocols in place. Monday through Friday.

This is a Contract position based out of Rocky Mount, NC.

The pay range for this position is $30.00 - $40.00/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)

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 actalentaccom for other accommodation options.