Specialist Quality Assurance
About the role
The Specialist Quality Assurance provides quality assurance oversight for facilities and utilities, ensuring compliant operation and release of systems and equipment. This role focuses on commissioning, qualification, and validation activities, approval of procedures and quality records, and partnership with operations and engineering teams to troubleshoot and resolve issues on critical utility systems.
Responsibilities
- Provide quality assurance oversight and release of facility and utility systems, including review and approval of procedures, protocols, change controls, and reports.
- Partner with operations and technical teams to troubleshoot problems as they arise on utility systems such as Water for Injection, Compressed Air, Clean Steam, Heating Hot Water skids, water and steam sampling systems, process gas equipment, and other equipment in the central utility building.
- Provide quality guidance and support during the execution of commissioning and qualification testing, ensuring that changes and discrepancies are properly reviewed, assessed, and approved.
- Author, own, review, and approve controlled documents including Standard Operating Procedures, validation protocols, validation reports, work instructions, and forms.
- Provide quality oversight for quality records such as deviations, corrective and preventive actions (CAPAs), change controls, and work orders, ensuring adherence to procedural requirements and completeness and accuracy of stakeholder assessments and evaluations.
- Ensure that all activities and related documentation for facilities, equipment, materials, and processes comply with applicable regulations and internal requirements related to Good Manufacturing Practices, Good Documentation Practices, safety, and controls.
- Support and contribute to continuous improvement initiatives aimed at enhancing quality systems, documentation, and operational reliability.
- Provide clear and timely updates to senior leadership, identify potential quality and compliance issues, and follow assignments through to full completion.
- Maintain strong attention to detail and a high degree of accuracy in task execution and GMP documentation, making data-driven, risk-based quality decisions.
- Adapt to evolving business needs, taking on additional responsibilities related to quality assurance oversight that may not be explicitly described but are associated with the role.
Essential Skills
- Experience and knowledge in commissioning, qualification, and validation activities, including utility systems validation for Water for Injection (WFI), United States Pharmacopeia (USP) water, Clean Steam, and Clean Air systems.
- Strong understanding of regulatory requirements, current regulatory trends, and relevant industry standards related to GMP and quality systems.
- Demonstrated ability to provide sound quality guidance and make data-driven, risk-based decisions in a regulated manufacturing environment.
- High level of attention to detail and accuracy in executing tasks and preparing or reviewing GMP documentation.
- Ability to provide clear updates to senior management, proactively identify potential issues, and drive assignments through to completion.
- Ability to collaborate effectively with cross-functional stakeholders, including engineering, operations, and maintenance, to resolve quality and technical issues.
- Experience working with facility and utility systems in a GMP-regulated environment.
- Familiarity with Good Documentation Practices and quality record management, including deviations, CAPAs, change controls, and work orders.
- Experience authoring, owning, and maintaining controlled documents such as SOPs, validation protocols, validation reports, work instructions, and forms.
- Experience supporting continuous improvement initiatives and contributing to optimization of quality and operational processes.
- Strong communication skills for interacting with stakeholders at various levels and for presenting updates to senior leadership.
- Demonstrated problem-solving skills in troubleshooting complex utility system issues within a regulated environment.
Additional Skills & Qualifications
- Experience working with facility and utility systems in a GMP-regulated environment.
- Familiarity with Good Documentation Practices and quality record management, including deviations, CAPAs, change controls, and work orders.
- Experience authoring, owning, and maintaining controlled documents such as SOPs, validation protocols, validation reports, work instructions, and forms.
- Experience supporting continuous improvement initiatives and contributing to optimization of quality and operational processes.
- Strong communication skills for interacting with stakeholders at various levels and for presenting updates to senior leadership.
- Demonstrated problem-solving skills in troubleshooting complex utility system issues within a regulated environment.
Work Environment
This is an onsite role with typical working hours from 8:00 a.m. to 5:00 p.m. local time. The position is based in a facility with central utility systems, including Water for Injection, Compressed Air, Clean Steam, Heating Hot Water skids, water and steam sampling systems, and process gas equipment. Work is performed in a GMP-regulated environment that emphasizes safety, adherence to procedures, and accurate documentation. The role involves close collaboration with operations, engineering, and maintenance teams in a professional setting focused on reliability, compliance, and continuous improvement.
Job Type & Location
This is a Contract position based out of Holly Springs, NC.
Pay And Benefits
The pay range for this position is $45.00 - $65.00/hr.
Requirements
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)
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 actalentaccommodation@actalentservices.com for other accommodation options.