Senior Quality Assurance Consultant

Job Description

Job Description

Job Title: Senior Quality Assurance Consultant
Job Description

The Senior Quality Assurance Consultant provides on-site quality oversight and support for pharmaceutical manufacturing operations focused on final drug product fill-finish, labeling, packaging, and batch release activities. This role serves as a key quality representative, partnering closely with manufacturing, quality systems, and site leadership to ensure timely batch disposition, adherence to GMP requirements, and continuous improvement of quality processes. The consultant identifies and addresses issues that may delay product release and drives quality decisions through to completion while influencing cross-functional teams through strong peer-to-peer communication.

Responsibilities

• Provide quality oversight for final drug product fill-finish manufacturing operations, ensuring compliance with GMP and internal quality standards.
• Support the review and disposition of manufacturing batches through batch release activities, including timely and thorough evaluation of batch documentation.
• Partner with site teams to improve batch release timelines and identify process improvement opportunities that enhance efficiency and compliance.
• Provide shop floor quality support during manufacturing operations, including real-time guidance and oversight of production activities.
• Review and support quality system records, including deviations, CAPAs, change controls, and investigations, ensuring they are managed in a compliant and timely manner.
• Ensure all quality records are completed accurately, thoroughly, and in accordance with GMP requirements and regulatory expectations.
• Escalate compliance concerns and quality risks appropriately to site leadership and relevant stakeholders, ensuring issues receive proper attention and resolution.
• Serve as the quality representative for manufacturing, labeling, and packaging activities, providing guidance on quality and compliance requirements.
• Support inspection readiness and compliance initiatives by helping prepare documentation, processes, and teams for regulatory and internal inspections.
• Collaborate with cross-functional stakeholders to drive quality actions to completion, ensuring commitments are met and improvements are sustained.
• Identify opportunities to strengthen quality processes and improve operational efficiency across manufacturing and quality systems.
• Partner with manufacturing, quality, technical operations, and leadership teams to align on quality expectations and drive consistent execution.
• Communicate effectively across all levels of the organization, providing clear, concise, and actionable quality-related updates and recommendations.
• Provide constructive challenge when necessary and advocate for compliance-focused decision making, balancing operational needs with regulatory and quality requirements.

• Bachelor's degree in a scientific or engineering discipline.
• 5–8+ years of Quality Assurance experience within a pharmaceutical manufacturing environment.
• Direct experience supporting drug product manufacturing and fill-finish operations.
• Hands-on experience with batch record review and batch release activities.
• Experience managing deviations, including investigation, documentation, and closure.
• Experience with CAPAs, including development, implementation, and effectiveness checks.
• Experience with change controls in a GMP-regulated manufacturing environment.
• Strong understanding of GMP-regulated pharmaceutical manufacturing environments and regulatory expectations.
• Solid knowledge of pharmaceutical quality systems and compliance requirements, including FDA and EMA expectations.
• Experience working with CMOs and CDMOs or similar external manufacturing partners.
• Proficiency in quality assurance practices related to labeling, packaging, and batch disposition.
• Ability to provide quality oversight on the shop floor and support real-time decision making.
• Strong communication skills with the ability to influence cross-functional teams and leadership.
• Ability to identify, assess, and escalate quality and compliance risks appropriately.

• Experience supporting injectable products, biologics, monoclonal antibodies, or aseptic manufacturing operations.
• Prior experience working in commercial pharmaceutical manufacturing environments.
• Experience supporting batch disposition and product release decisions in a commercial setting.
• Familiarity with inspection readiness activities and regulatory inspection support.
• Experience working with contract manufacturing and development organizations (CMOs and CDMOs).
• Strong problem-solving skills with the ability to identify process improvement opportunities within quality systems and manufacturing operations.
• Demonstrated ability to provide constructive challenge and advocate for compliance-focused decisions.
• Comfort working in a highly visible role with significant cross-functional interaction and responsibility.

This is an on-site role supporting pharmaceutical manufacturing operations in a GMP-regulated environment. The position follows a Monday–Friday, first-shift schedule, with occasional requirements to provide shop floor support during manufacturing activities. The role involves entering manufacturing areas, which may require appropriate gowning and adherence to cleanroom or controlled area procedures. The work setting is highly collaborative, with frequent interaction across Quality, Manufacturing, and Technical Operations teams. The environment emphasizes cross-functional partnership, real-time quality oversight, and a strong culture of compliance and continuous improvement.

Job Type & Location

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

The pay range for this position is $70.00 - $90.00/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)

This is a fully onsite position in Greenville,NC.

This position is anticipated to close on Jul 18, 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 [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.