Quality Engineer III

The Quality Engineer III drives quality execution across sterile operations, including manufacturing, filling, packaging, inspection, and associated nonbatch-specific activities for both commercial and product development services. This role provides quality guidance and expertise to support practical process improvements and continuous improvement initiatives, ensuring compliance with site procedures and current Good Manufacturing Practices (cGMP). Typical working hours are 6:00 a.m. to 6:00 p.m. on a 2-2-3 rotation schedule.

• Perform daily quality assessments of facilities, personnel, and documentation in both classified and non-classified areas to uncover errors or deficiencies and ensure compliance with site procedures and cGMP requirements.
• Interact daily with production employees to assist with troubleshooting, documentation corrections and notes, and provide guidance on aseptic technique and best practices.
• Champion a strong quality culture by helping personnel understand and correctly apply quality policies, procedures, and controls.
• Participate in RAPID event responses and provide quality guidance and support for deviation events.
• Advance deviation events to the appropriate operational area and quality management for timely review and resolution.
• Perform quality review and approval of procedures, training documents, and forms of moderate to high complexity.
• Perform quality review and approval of deviations and change controls of moderate to high complexity.
• Serve as the quality assurance representative in root cause analyses to support deviation investigations of moderate to high complexity.
• Conduct quality batch record reviews to verify completeness, accuracy, and compliance with cGMP and internal standards.
• Identify opportunities for continuous improvement and actively participate in practical process improvement initiatives.
• Capture and analyze process data to help troubleshoot process and equipment issues in collaboration with production leadership.
• Provide leadership, support, and empowerment to peers and cross-functional teams in matters related to quality assurance and compliance.
• Prepare clear, accurate technical documents and reports using strong technical writing skills.
• Maintain a consistent presence on the production floor, adhering to aseptic and non-aseptic gowning requirements and safety practices.

• Bachelors degree, preferably in technology, engineering, microbiology, or a related field, or an equivalent combination of education, training, and relevant work experience.
• Minimum of 4 years of experience, with previous experience in Quality Assurance, Quality Control, or Operations/Manufacturing.
• Previous experience in the pharmaceutical industry, preferably with aseptic or sterile processes; experience in other regulated environments such as ISO 9001 may be considered.
• Strong understanding of cGMP principles and their application in a regulated manufacturing environment.
• Proven ability to capture data, analyze trends, and troubleshoot process issues and equipment problems in partnership with production leadership.
• Demonstrated ability to troubleshoot process and equipment issues efficiently and methodically.
• Experience in quality review and approval of procedures, training documents, deviations, change controls, and batch records.
• Technical writing experience with the ability to create clear, concise, and compliant documentation.
• Demonstrated ownership, responsibility, and a hard-working approach to meeting quality and operational goals.
• Ability to lead, support, and empower teams and peers in a collaborative environment.
• Physical fitness to maintain consistent production floor presence, including prolonged standing, walking, repetitive bending, and aseptic and non-aseptic gowning.
• Ability to lift, carry, and move light to medium weights of approximately 1035 pounds.
• Sufficient ambulatory skills and physical coordination to move about office and production locations, including standing, walking, stooping, kneeling, and crouching periodically for prolonged periods.
• Arm, hand, and finger dexterity to grasp and type for prolonged periods, and visual acuity to use a keyboard, monitor, operate equipment, and read materials for extended durations.
• Ability to sit, reach with hands and arms, talk, and hear for prolonged periods while performing job duties.

• Professional certifications in quality, such as Certified Quality Auditor (CQA), are a plus.
• Training in Six Sigma or similar continuous improvement methodologies is highly desirable.
• Experience working within ISO 9001 or other regulated quality management systems is beneficial.
• Strong interpersonal and communication skills to effectively interact with personnel at all levels of the organization.
• Demonstrated ability to champion a quality-focused culture and influence adherence to policies and controls.
• Proven capability to participate in and contribute to root cause analysis and deviation investigations.
• Comfort working in a fast-paced, highly regulated environment with a focus on sterile and aseptic operations.

This role is primarily based on the production floor within sterile and non-sterile pharmaceutical manufacturing areas, requiring a consistent on-site presence. The position follows a 6:00 a.m. to 6:00 p.m. schedule on a 2-2-3 rotation, which includes a mix of weekdays and weekends. Work involves both classified and non-classified areas, with frequent movement between office spaces and manufacturing environments. The role requires prolonged standing, walking, bending, and other physical activities, as well as regular interaction with production teams. Personal protective equipment such as safety glasses, safety shoes, lab coats, nitrile or similar gloves, safety aprons, and organic respirators is used as needed to ensure safety and compliance. The environment emphasizes adherence to cGMP, aseptic and non-aseptic gowning requirements, and a strong quality culture, supported by collaborative teamwork and continuous improvement initiatives.

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

The pay range for this position is $56.50 - $56.50/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)

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

This position is anticipated to close on Oct 27, 2026.

This is a fully onsite position in Bailey,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 withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email for other accommodation options.

San Francisco Fair Chance Ordinance:Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records.

Massachusetts Lie Detector:It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall 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 applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.