Job Description
Job Title: Specialist Quality Assurance (QA)
Job Description
The Specialist Quality Assurance (QA) will provide essential quality support and oversight for the commissioning, qualification, and process qualification of the facility, utilities, computer systems, and equipment. Collaborating cross-functionally, you will ensure that project timelines and milestones are successfully met.
Responsibilities
+ Support the quality oversight associated with Commissioning & Qualification (C&Q) and validation activities for the site, involving facilities/utilities, equipment/systems, computerized systems, process, and validation maintenance.
+ Perform quality reviews of documents to support facility commissioning and qualification in alignment with project timelines.
+ Review and approve Commissioning/Qualification Protocols, Performance Qualification Protocols (PQ), protocol discrepancies, and Final Reports and Summary Documents.
+ Provide quality support during execution of commissioning and qualification testing, reviewing and approving changes and discrepancies as needed.
+ Ensure compliance of all activities and related documentation for facilities, equipment, materials, and processes with applicable regulations and requirements related to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls.
+ Collaborate with authors and engineers to address document gaps or discrepancies, providing timely feedback.
+ Participate in meetings related to document planning, execution, and issue resolution.
+ Escalate any compliance concerns or critical gaps to QA management.
+ Additional responsibilities may evolve in line with business requirements.
Essential Skills
+ Understanding of regulatory requirements, trends, and industry standards.
+ Experience or knowledge in commissioning/qualification/validation, including computer-systems validation.
+ Excellent written and verbal communication skills.
+ Ability to work effectively in a team matrix environment and build relationships with partners.
+ Great attention to detail and high degree of accuracy in task execution and GMP documentation.
+ Capability to complete tasks autonomously, providing updates to management, identifying potential issues, and following assignments through to completion.
+ Proven experience applying GMP requirements in an operational and Quality Control setting.
Additional Skills & Qualifications
+ Doctorate degree, or Master degree with 3 years of experience, or Bachelor degree with 5 years of experience, or Associate degree with 10 years of experience, or High school diploma / GED with 12 years of experience.
Work Environment
This is an on-site position requiring the ability to gown in, and/or wear construction gear including steel toe boots.
Job Type & Location
This is a Contract position based out of Apex, NC.
Pay and Benefits
The pay range for this position is $30.00 - $33.00/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 Apex,NC.
Application Deadline
This position is anticipated to close on Jan 28, 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.
Job Description
The Specialist Quality Assurance (QA) will provide essential quality support and oversight for the commissioning, qualification, and process qualification of the facility, utilities, computer systems, and equipment. Collaborating cross-functionally, you will ensure that project timelines and milestones are successfully met.
Responsibilities
+ Support the quality oversight associated with Commissioning & Qualification (C&Q) and validation activities for the site, involving facilities/utilities, equipment/systems, computerized systems, process, and validation maintenance.
+ Perform quality reviews of documents to support facility commissioning and qualification in alignment with project timelines.
+ Review and approve Commissioning/Qualification Protocols, Performance Qualification Protocols (PQ), protocol discrepancies, and Final Reports and Summary Documents.
+ Provide quality support during execution of commissioning and qualification testing, reviewing and approving changes and discrepancies as needed.
+ Ensure compliance of all activities and related documentation for facilities, equipment, materials, and processes with applicable regulations and requirements related to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls.
+ Collaborate with authors and engineers to address document gaps or discrepancies, providing timely feedback.
+ Participate in meetings related to document planning, execution, and issue resolution.
+ Escalate any compliance concerns or critical gaps to QA management.
+ Additional responsibilities may evolve in line with business requirements.
Essential Skills
+ Understanding of regulatory requirements, trends, and industry standards.
+ Experience or knowledge in commissioning/qualification/validation, including computer-systems validation.
+ Excellent written and verbal communication skills.
+ Ability to work effectively in a team matrix environment and build relationships with partners.
+ Great attention to detail and high degree of accuracy in task execution and GMP documentation.
+ Capability to complete tasks autonomously, providing updates to management, identifying potential issues, and following assignments through to completion.
+ Proven experience applying GMP requirements in an operational and Quality Control setting.
Additional Skills & Qualifications
+ Doctorate degree, or Master degree with 3 years of experience, or Bachelor degree with 5 years of experience, or Associate degree with 10 years of experience, or High school diploma / GED with 12 years of experience.
Work Environment
This is an on-site position requiring the ability to gown in, and/or wear construction gear including steel toe boots.
Job Type & Location
This is a Contract position based out of Apex, NC.
Pay and Benefits
The pay range for this position is $30.00 - $33.00/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 Apex,NC.
Application Deadline
This position is anticipated to close on Jan 28, 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.
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