"Alerted.org

Job Title: Quality EngineerJob Description

As the primary Quality Owner, you will oversee all plant facilities, equipment, and associated critical systems to ensure compliance and efficient approval processes. You will lead risk and gap assessments to maintain control over critical systems and drive quality enhancement projects to meet regulatory standards. Your collaboration with various departments will be key in solving compliance issues and enhancing quality systems.

Responsibilities

+ Deliver quality ownership of facilities, equipment, and associated processes.

+ Drive engineering change control for critical equipment and controlled areas, ensuring timely pre-approval and post-approval.

+ Perform impact assessments for Critical Systems for presentation to the Change Control Review Board.

+ Provide support during operational run times and maintenance shutdown activities, including off-shift coverage.

+ Offer quality oversight for software validation, equipment qualification, and facility commissioning.

+ Troubleshoot issues related to critical systems and equipment, implementing corrective and preventive actions.

+ Collaborate with Engineering & Maintenance to identify trends and assess impact.

+ Act as the main point of contact in quality projects, driving improvements to meet regulatory requirements.

+ Review and approve investigations related to critical systems and equipment, conducting root cause investigations and gap analyses.

+ Analyze data, develop corrective or preventive actions, and implement changes to improve compliance and efficiency.

+ Review and approve quality documentation such as deviation investigations, ensuring adequate root cause analysis and corrective actions.

+ Maintain critical system quality metrics to drive continuous improvement.

+ Provide training and mentorship to personnel regarding facilities and equipment quality systems.

+ Interact with Regulatory Officials to convey compliance levels during inspections.

Essential Skills

+ Bachelor's degree in technical science, engineering, information systems, or related field.

+ 5-8 years of manufacturing experience, with an emphasis in the pharmaceutical industry.

+ Excellent attention to detail and working knowledge of FDA Regulations/Guidance and Good Manufacturing Practices.

+ Technical quality systems knowledge, qualification, and validation practices.

+ Working knowledge of aseptic processing preferred.

+ Understanding of cGMP practices, including 21 CFR Part 210, 211, and Part 11.

+ Proactive mindset with experience in high-performance teams, strong interpersonal and leadership skills.

+ Computer expertise in applications like word processing, spreadsheets, databases, and project management.

Additional Skills & Qualifications

+ Skilled in continuous process improvement tools such as Six Sigma, Lean Manufacturing, DMAIC preferred.

+ Ability to work independently and collaboratively, with proven initiative and drive to achieve results.

Work Environment

This position is based on-site in Wilson, NC. The role requires working within plant facilities, collaborating with various departments to ensure compliance and quality enhancement. Dress code and specific equipment details are not explicitly stated but expect a professional and safety-focused environment.

Job Type & Location

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

Pay and Benefits

The pay range for this position is $40.00 - $50.00/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 Wilson,NC.

Application Deadline

This position is anticipated to close on Jan 30, 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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

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 due to a disability, please email [email protected] (%[email protected]) for other accommodation options.