Quality Assurance Associate

Actalent; Sanford (NC); On-site; USD 52,000 - 58,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Plan

Life Insurance

PTO / Vacation

Sick Leave

Job summary

Actalent in Sanford, NC seeks a Quality Assurance Operations Specialist II to launch and lead QA systems for a monoclonal antibody facility. The role blends GMP readiness, tech transfer, and licensure activities, ensuring global GxP compliance across site operations.

You will perform batch record reviews, QA oversight on the floor, CAPA handling, deviations, and change controls within Veeva, while fostering a culture of quality from construction through operation.

Qualifications

• Advanced Quality Assurance expertise.
• Experience in batch record review and GMP.
• Capability in QA - On the Floor QA, Batch Release, and Batch Disposition.
• Proficiency in CAPA and Investigations.

Responsibilities

• Execute QA activities including batch record review and QA oversight of warehouse and incoming quality.
• Collaborate cross-functionally to monitor site quality metrics and investigate deviations.
• Lead regulatory readiness activities and ensure GxP compliance across operations.
• Participate in regulatory inspections and drive quality culture initiatives.
• Lead investigations of non-conformances and drive CAPA actions.

Skills

Advanced QA

Batch record review

GMP

On-the-Floor QA

Batch Release

Batch Disposition

CAPA investigations

Tools

Veeva Quality Management System

Job description

Job Title: Quality Assurance Operations Specialist II Job Description
The Quality Assurance Operations Specialist II plays a pivotal role in the launch and ongoing operations of the Quality Assurance organization at a new monoclonal antibody drug substance manufacturing facility. Starting in a greenfield environment, you will help establish QA systems and processes, then transition into providing technical leadership through GMP readiness, technology transfer, and facility licensure for late clinical and commercial products. You will ensure that all GxP areas within the Site Operations maintain full compliance with current GxP standards and all applicable global, regional, and site procedures within the Quality Management System. This role offers a unique opportunity to shape a culture of quality from the ground up while contributing to the delivery of life-changing therapies.

Responsibilities

• Execute core QA activities such as batch record review, Manufacturing Quality Assurance, QA oversight of warehouse, and incoming quality.
• Collaborate cross-functionally to monitor site quality metrics, investigate deviations, and support continuous improvement initiatives.
• Leverage the Global Quality Management System to ensure alignment with regulatory requirements, including data integrity standards.
• Participate in regulatory inspections and lead quality culture initiatives.
• Apply advanced Quality Assurance expertise across GxP operations to support compliant manufacturing.
• Perform as Shop Floor QA / Manufacturing QA with presence on the manufacturing floor; able to stand for 3 or more hours.
• Independently execute batch record review and approval, participate in Gemba walks, coordinate alarm responses, and conduct logbook audits.
• Participate in batch disposition and support final product release by verifying documentation and quality standards.
• Support Warehouse and Incoming Quality activities by ensuring materials meet defined specifications and quality requirements.
• Review and approve Change Controls, CAPAs, and Deviations in Veeva.
• Identify and elevate discrepancies or non-compliant entries within the Quality Management System (Veeva), collaborating with process owners.
• Lead investigations of non-conformances, deviations, laboratory exceptions, and other cGMP issues; initiate CAPAs.
• Monitor and analyze site quality metrics to identify trends, support continuous improvement, and ensure compliance.
• Review and approve procedures within Veeva, leveraging the global, regional, and local SOPs.
• Champion a culture of quality in all GxP areas within the Site Operations.
• Develop, monitor, and communicate progress against goals across functions to ensure alignment and accountability.
• Ensure compliance with current regulatory requirements for Data Integrity (ALCOA+) as applicable to paper and electronic records.

Essential Skills

• Advanced Quality Assurance expertise.
• Experience in batch record review and GMP.
• Capability in QA - On the Floor QA, Batch Release, and Batch Disposition.
• Proficiency in CAPA and Investigations.

Additional Skills & Qualifications

• Knowledge of Veeva Quality Management System.
• Familiarity with regulatory compliance and Data Integrity (ALCOA+).

Work Environment

During construction and commissioning, this position will follow a Monday-Friday day shift schedule. Once the facility is operational, the role will transition to a 2-2-3 day shift (7:00 AM 7:00 PM). Shift flexibility may be required during production runs. This position is located on-site in Sanford, NC.

Job Type & Location

This is a Contract position based out of Sanford, NC.

Pay and Benefits

The pay range for this position is $38.00 - $42.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. 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)

Application Deadline

This position is anticipated to close on Oct 30, 2026.

Workplace Type

This is a fully onsite position in Sanford, NC.

Equal Opportunity Employer

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.

Reasonable Accommodation

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 [e-mail] for other accommodation options.

San Francisco Fair Chance Ordinance

Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI)

We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.