Job Title: Quality Assurance Associate

Job Description

We are seeking a Quality Assurance Associate to support one of our largest pharmaceutical clients. The QA Associate will be responsible for real-time batch record review on the manufacturing shop floor, ensuring compliance with regulations and internal procedures.

Responsibilities

• Execute real-time review of batch documentation and other manufacturing documentation, analyzing for errors, corrections, and compliance.
• Perform housekeeping and GMP walkthroughs of the facility.
• Initiate and participate in triage for on-the-floor events.
• Work in cross-functional teams to meet and exceed timelines.
• Execute or review room and line clearances.
• Make quality decisions in real-time according to regulations ICH Q7, 21CFR211, and internal procedures.

Essential Skills

• Experience in batch record review.
• GMP experience in a manufacturing facility.
• Quality assurance expertise.
• Bachelor's degree.

Additional Skills & Qualifications

• Experience with SAP.
• Proficiency in Veeva Vault.
• Knowledge of Trackwise.
• Experience in biologics manufacturing.
• Experience in vaccine manufacturing.

Work Environment

The position operates on a shift schedule with a rotation. The designated shift is days/Sat rotation SHIFT C (Wed-Sat), with training occurring Monday to Friday until sign-off. Following training, the shift will be from 7 am to 7 pm for days or 7 pm to 7 am for nights. Team members will work either 3 days one week and 4 days the following, always working a Saturday or Sunday depending on the rotation. The role requires 90-100% of the shift to be spent on the shop floor, with business casual attire and closed-toed shoes required initially, transitioning to gowning procedures as needed.

Pay and Benefits

The pay range for this position is $40.00 - $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 Sanford,NC.

Application Deadline

This position is anticipated to close on Feb 21, 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 for other accommodation options.

Salary : $40 - $50