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Process Quality Engineer

Actalent

Raleigh · On-site Contract Mid Level $40 – $45/hr Today

About the role

About the Role

We are actively hiring a In-Process Quality Engineer for a CDMO located in RTP, NC. This role provides real‑time, on‑floor quality oversight within a cGMP pharmaceutical manufacturing environment. You’ll support production, packaging, and warehouse operations to ensure products are manufactured safely, compliantly, and according to site procedures.

What You’ll Do

  • Provide on‑floor QA oversight across formulation, filling, sterilization, packaging, and warehouse operations
  • Monitor daily activities to ensure compliance with cGMPs, SOPs, and site quality standards
  • Support required QA inspections, including visual defect detection and sample checks
  • Perform routine in‑process quality tasks such as:
    • Packaging line clearance verification
    • Material segregation and containment
    • Low‑fill response and product accountability
    • Rework reconciliation
    • Real‑time documentation review
  • Serve as the primary QA responder for on‑floor exceptions, including:
    • Initial impact assessments
    • Product containment and bracketing
    • Identifying scope and directing immediate corrective actions
  • Assist operations personnel with generating exceptions and support minor deviations and Phase II investigations
  • Participate in daily operations meetings and Facilities/PM/Calibration scheduling discussions
  • Support punch‑list activities, area inspections, and pre/post‑maintenance verifications
  • Conduct weekly walkthroughs of production and packaging areas, documenting and communicating observations
  • Support batch release activities as needed
  • Complete all documentation accurately (batch records, logbooks, deviation reports) in alignment with cGMP and data integrity requirements
  • Promptly report and assist in investigations related to contamination events or deviations from aseptic practices

Required Skills & Qualifications

  • Bachelor’s degree in Life Sciences, Engineering, or related technical field
  • 3–6 years of experience in pharmaceutical manufacturing, quality assurance, or aseptic operations
  • Strong working knowledge of GMP, QA principles, CAPA, gowning, and SOPs
  • Ability to pass a visual acuity exam for product inspection
  • Ability to read and interpret military time
  • Excellent reading comprehension and attention to detail for reviewing batch records and SOPs
  • Understanding of sterilization processes, material flows, and controlled environment requirements
  • Strong situational awareness and decision‑making in fast‑paced, regulated environments
  • Commitment to safety, quality culture, and compliance
  • Ability to work independently and collaboratively across cross‑functional teams

Experience Level

Intermediate (3–6 years)

Job Type & Location

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

Pay and Benefits

The pay range for this position is $40.00 - $45.00/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 Raleigh, NC.

Application Deadline

This position is anticipated to close on Apr 14, 2026.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:

  • Hiring diverse talent
  • Maintaining an inclusive environment through persistent self‑reflection
  • Building a culture of care, engagement, and recognition with clear outcomes
  • Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.

Requirements

  • Bachelor’s degree in Life Sciences, Engineering, or related technical field
  • 3–6 years of experience in pharmaceutical manufacturing, quality assurance, or aseptic operations
  • Strong working knowledge of GMP, QA principles, CAPA, gowning, and SOPs
  • Ability to pass a visual acuity exam for product inspection
  • Ability to read and interpret military time
  • Excellent reading comprehension and attention to detail for reviewing batch records and SOPs
  • Understanding of sterilization processes, material flows, and controlled environment requirements
  • Strong situational awareness and decision-making in fast-paced, regulated environments
  • Commitment to safety, quality culture, and compliance
  • Ability to work independently and collaboratively across cross-functional teams

Responsibilities

  • Provide on-floor QA oversight across formulation, filling, sterilization, packaging, and warehouse operations
  • Monitor daily activities to ensure compliance with cGMPs, SOPs, and site quality standards
  • Support required QA inspections, including visual defect detection and sample checks
  • Perform routine in-process quality tasks such as: Packaging line clearance verification, Material segregation and containment, Low-fill response and product accountability, Rework reconciliation, Real-time documentation review
  • Serve as the primary QA responder for on-floor exceptions, including: Initial impact assessments, Product containment and bracketing, Identifying scope and directing immediate corrective actions
  • Assist operations personnel with generating exceptions and support minor deviations and Phase II investigations
  • Participate in daily operations meetings and Facilities/PM/Calibration scheduling discussions
  • Support punch-list activities, area inspections, and pre/post-maintenance verifications
  • Conduct weekly walkthroughs of production and packaging areas, documenting and communicating observations
  • Support batch release activities as needed
  • Complete all documentation accurately (batch records, logbooks, deviation reports) in alignment with cGMP and data integrity requirements
  • Promptly report and assist in investigations related to contamination events or deviations from aseptic practices

Benefits

health_insurancepaid_time_offdental_coverage

Skills

CAPAcGMPGMPQASOPs

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