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Job Title: Quality Assurance Senior Associate

Job Description

We are seeking a dedicated Quality Assurance Senior Associate to join our team. This fully onsite position follows a stable shift schedule that includes weekends and possibly nights. The role requires a background in manufacturing and PQA. As a Sr. Associate in Plant Quality Assurance, you will work directly with plant manufacturing and support groups on bulk drug substance manufacturing and new product introductions. You will facilitate real-time decision-making to ensure adherence to GMP quality requirements and foster a strong partnership between Manufacturing and Quality staff.

Responsibilities

+ Provide ongoing Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and other applicable regulations.

+ Ensure compliance of facilities, equipment, materials, organization, processes, and procedures with applicable regulations and requirements relating to GMP, GDP, Safety, and other controls.

+ Drive closure and completion of cGMP processes, procedures, documents, and records, including review and approval of deviations, investigations, and corrective/preventative actions (CAPAs).

+ Ensure production and testing records/results are complete, accurate, and documented according to procedures, GDP, and cGMP requirements.

+ Oversee and provide guidance during on-the-floor analytical testing.

+ Assess changes that could potentially impact product quality according to procedures.

+ Investigate and document deviations from established procedures per guidelines.

+ Alert management of quality compliance, supply, and safety risks.

+ Provide project management support, leading efforts to achieve timely task completion and develop strategies for system implementation.

+ Identify and implement continuous improvement opportunities within processes and systems.

+ Support and represent PQA during audits and inspections, and directly interact with regulatory agencies during on-site inspections.

Essential Skills

+ Quality assurance

+ Manufacturing

+ Batch Records

+ Deviations

+ QA Oversight

+ Experience in GNP Facilities

+ PQA or Manufacturing experience, preferably in Drug Substance

Additional Skills & Qualifications

+ High school diploma/GED with 4 years of work experience or Associate degree with 2 years of work experience or Bachelor's degree with 6 months of work experience or Master's degree

Work Environment

This is an on-the-floor position providing guidance and support to manufacturing. You will oversee compliance in execution, review batch records, review and approve SOPs, and review deviations. You will also assist manufacturing in problem-solving with a quality mindset.

Job Type & Location

This is a Contract position based out of Holly Springs, NC.

Pay and Benefits

The pay range for this position is $31.00 - $34.00/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 Holly Springs,NC.

Application Deadline

This position is anticipated to close on Jan 29, 2026.

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 [email protected] (%[email protected]) for other accommodation options.