Quality Assurance Engineer

IntelliPro Group Inc. • Research Triangle Park, NC

2d • $45 - $53 • Onsite

About The Position

Collaborate with department teams to develop, implement, and integrate Equipment and Computer Systems Validation plans for site-wide equipment onboarding.
Provide timely quality support, including thorough review and approval of records such as:
Change Controls
Standard Operating Procedures (SOPs)
Analytical methods
Equipment and computer system qualification and validation plans, protocols, and summary reports
Batch records
QC data
Non-conformities and CAPAs
Ensure QA activities are completed within established project timelines and escalate concerns when necessary.
Report key quality metrics to support continuous compliance improvement.
Participate in project meetings as a quality representative and provide technical quality and compliance guidance.
Collaborate cross-functionally to resolve compliance and validation-related issues.
Maintain Quality Systems, including:
Reviewing and approving SOP drafts and revisions
Processing change controls
Supporting equipment and computer system qualification and validation activities
Supporting vendor management programs
Communicating project status and escalating issues to stakeholders

Requirements

• Bachelor’s degree in a scientific discipline.
• Minimum 5 years of experience in pharmaceutical, biotech, or biologics GMP-regulated manufacturing, including at least 3 years in Quality and/or Manufacturing.
• Strong understanding of GMP guidelines and Quality Systems with the ability to apply U.S. and other regulatory standards as applicable.
• Experience authoring, reviewing, and interpreting SOPs.
• Strong problem-solving skills with the ability to address quality issues in a proactive and collaborative manner.
• Excellent organizational skills with strong attention to detail and ability to manage multiple priorities.
• Strong written and verbal communication skills with the ability to collaborate with scientific and technical teams.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).

Responsibilities

• Collaborate with department teams to develop, implement, and integrate Equipment and Computer Systems Validation plans for site-wide equipment onboarding.
• Provide timely quality support, including thorough review and approval of records such as: Change Controls Standard Operating Procedures (SOPs) Analytical methods Equipment and computer system qualification and validation plans, protocols, and summary reports Batch records QC data Non-conformities and CAPAs
• Ensure QA activities are completed within established project timelines and escalate concerns when necessary.
• Report key quality metrics to support continuous compliance improvement.
• Participate in project meetings as a quality representative and provide technical quality and compliance guidance.
• Collaborate cross-functionally to resolve compliance and validation-related issues.
• Maintain Quality Systems, including: Reviewing and approving SOP drafts and revisions Processing change controls Supporting equipment and computer system qualification and validation activities Supporting vendor management programs Communicating project status and escalating issues to stakeholders

What This Job Offers

• Career Level: Mid Level