Quality Assurance Senior Associate

Job Title: Quality Assurance Senior Associate

Job Description

The Quality Assurance Senior Associate will work fully onsite in a shift-based role, partnering closely with manufacturing and support teams to oversee bulk drug substance production and new product introductions across development, clinical, and commercial operations. This plant quality assurance, on-the-floor position facilitates real-time decision making to ensure strict adherence to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and applicable regulations. The role offers a unique opportunity to strengthen collaboration between Manufacturing and Quality by providing coaching, guidance, and direction on manufacturing events, deviations, quality systems, and compliance.

Responsibilities

• Provide ongoing quality oversight to ensure products are manufactured, tested, stored, and distributed in accordance with cGMP, GDP, and other applicable regulations.
• Ensure that facilities, equipment, materials, organizational structures, processes, and procedures comply with applicable regulations and internal requirements related to Good Manufacturing Practices, Good Documentation Practices, safety, and other controls.
• Drive closure and completion of cGMP processes, procedures, documents, and records, including reviewing and approving deviations, investigations, and corrective and preventive actions (CAPAs).
• Verify that production and testing records and results are complete, accurate, and documented according to established procedures, GDP, and cGMP requirements.
• Oversee and provide guidance during on-the-floor analytical testing to ensure compliance with quality standards.
• Ensure that changes with potential impact on product quality are assessed and documented according to established procedures.
• Confirm that deviations from established procedures are properly investigated and documented in line with procedural requirements.
• Alert Senior leadership to quality, compliance, supply, and safety risks in a timely and clear manner.
• Provide project management support by leading efforts to achieve tasks on schedule and developing strategies for system implementation.
• Identify and implement continuous improvement opportunities within quality-related processes and systems.
• Support and represent plant quality assurance during audits and inspections, and directly interact with regulatory agencies during on-site inspections as needed.

Essential Skills

• Strong understanding and demonstrated behaviors aligned with current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).
• Experience working in a biotechnology or similarly highly regulated manufacturing environment.
• Knowledge and hands-on process experience within a cGMP manufacturing facility.
• Technical understanding of upstream and/or downstream manufacturing operations in biotechnology production.
• Proficiency with Microsoft Office applications.
• Experience with electronic systems such as Electronic Batch Records/Manufacturing Execution Systems (EBR/MES), DeltaV, and electronic quality systems.
• Ability to make real-time quality decisions on the manufacturing floor in alignment with regulatory and procedural requirements.
• Strong attention to detail and accuracy in reviewing and approving cGMP documentation, deviations, investigations, and CAPAs.
• Effective communication skills to provide guidance, coaching, and clear escalation of quality and compliance risks.

Additional Skills & Qualifications

• High school diploma or GED with at least 4 years of relevant work experience, or
• Associate degree with at least 2 years of relevant work experience, or
• Bachelor's degree with at least 6 months of relevant work experience, or
• Master's degree in a relevant field.
• Experience supporting audits and inspections, including direct interaction with regulatory agencies.
• Background in project management or leading implementation of quality or manufacturing systems.
• Demonstrated ability to identify and drive continuous improvement initiatives within quality or manufacturing processes.

Work Environment

This role is fully onsite in a plant manufacturing environment and follows a shift work schedule that includes weekends and may include night shifts. The specific shift will be determined during the hiring process, and once assigned, the schedule remains stable. The position is primarily on the manufacturing floor, working closely with production and analytical testing teams in a cGMP biotechnology facility that uses electronic systems such as EBR/MES, DeltaV, and electronic quality platforms. The environment is highly regulated and process-driven, with a strong focus on safety, documentation accuracy, and compliance with quality standards.

Job Type & Location

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

Pay and Benefits

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)

Workplace Type

This is a fully onsite position in Holly Springs,NC.

Application Deadline

This position is anticipated to close on Aug 5, 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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service.

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.

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.