Quality Assurance Senior Associate

Job Title: Quality Assurance Senior Associate Job Description
The Quality Assurance Senior Associate plays a key on-the-floor role within a bulk drug substance manufacturing environment, partnering closely with manufacturing and support teams across development, clinical, and commercial operations. This position facilitates real-time decision making to ensure strict adherence to current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP), while supporting new product introductions and ongoing production. The role focuses on maintaining a strong, collaborative learning environment between Manufacturing and Quality, providing coaching, guidance, and direction on manufacturing events, deviations, quality systems, and overall compliance.
Responsibilities
- Provide ongoing quality oversight to ensure products are manufactured, tested, stored, and distributed in accordance with current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and other applicable regulations.
- Ensure that facilities, equipment, materials, organizational structures, processes, and procedures comply with applicable regulations and internal requirements related to cGMP, GDP, 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).
- Confirm 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 and procedures.
- Ensure that changes with potential impact on product quality are appropriately assessed and managed according to established change control procedures.
- Ensure that deviations from established procedures are thoroughly investigated, documented, and resolved in line with procedural requirements.
- Alert Senior leadership to significant quality, compliance, supply, and safety risks in a timely and clear manner.
- Provide project management support by leading efforts to drive timely completion of tasks and developing strategies for quality system implementation.
- Identify and implement continuous improvement opportunities within quality processes and systems to enhance efficiency and compliance.
- Support and represent Plant Quality Assurance (PQA) during internal and external audits and inspections, and interact directly with regulatory agencies during on-site inspections when required.
Essential Skills
- Hands-on experience in manufacturing and plant quality assurance (PQA) within a cGMP environment or other highly regulated setting.
- Strong behaviors and practical application of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).
- Experience in biotechnology, with knowledge and process experience within a cGMP manufacturing facility.
- Technical understanding of upstream and/or downstream manufacturing processes within a biotechnology production operation.
- Proficiency with Microsoft Office applications.
- Experience using electronic systems such as Electronic Batch Records/Manufacturing Execution Systems (EBR/MES), DeltaV, and Electronic Quality Systems.
- Ability to review batch records, manage deviations, and perform investigation reviews with a high level of attention to detail.
- Strong understanding and practical use of standard operating procedures (SOPs) in a manufacturing and quality context.
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
- Bachelors degree with at least 6 months of relevant work experience, or
- Masters degree with relevant academic or practical experience.
- Experience supporting manufacturing operations through quality oversight on the production floor.
- Familiarity with documentation practices, batch record review, deviation management, and investigation review in a regulated environment.
- Ability to provide coaching and guidance to manufacturing staff on quality events, deviations, and compliance expectations.
- Strong organizational, communication, and problem-solving skills to support real-time decision making and project management activities.
Work Environment
This role is fully onsite on a manufacturing floor in a plant quality assurance setting, providing direct, on-the-floor support to bulk drug substance operations. The position follows a shift work schedule that includes weekends and may include nights. The specific shift will be determined upon hire, and once assigned, the schedule will remain stable. The environment is highly regulated, focused on biotechnology manufacturing under cGMP conditions, and involves close collaboration with manufacturing, analytical, and quality teams in a dynamic production setting.
Job Type & Location
This is a Contract position based out of Holly Springs, NC.
Pay and Benefits
The pay range for this position is $42.00 - $48.00/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)
Job Type & Location
This is a Contract position based out of Holly Springs, NC.
Application Deadline
This position is anticipated to close on Nov 12, 2026.
Workplace Type
This is a fully onsite position in Holly Springs,NC. 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 [email protected] 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.