Quality Assurance Engineer
Position Type: 10 Months Contract
Location: Onsite – Research Triangle Park, NC, United States (27709)
Rate: $45/hr. - $53/hr.
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
- 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).
Founded in 2009, IntelliPro is a global leader in talent acquisition and HR solutions. Our commitment to delivering unparalleled service to clients, fostering employee growth, and building enduring partnerships sets us apart. We continue leading global talent solutions with a dynamic presence in over 160 countries, including the USA, China, Canada, Singapore, Japan, Philippines, UK, India, Netherlands, and the EU. IntelliPro, a global leader connecting individuals with rewarding employment opportunities, is dedicated to understanding your career aspirations. As an Equal Opportunity Employer, IntelliPro values diversity and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, genetic information, disability, or any other legally protected group status. Moreover, our Inclusivity Commitment emphasizes embracing candidates of all abilities and ensures that our hiring and interview processes accommodate the needs of all applicants. Learn more about our commitment to diversity and inclusivity at . Compensation: The pay offered to a successful candidate will be determined by various factors, including education, work experience, location, job responsibilities, certifications, and more. Additionally, IntelliPro provides a comprehensive benefits package, all subject to eligibility.
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