Quality Assurance Technical Reviewer

United States·Vega Bajamid

OtherQuality Assurance

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Quick Summary

Key Responsibilities

Review and audit validation,

Technical Tools

OtherQuality Assurance

Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG ensures compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston, United States, we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.

Responsibilities

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Review and audit validation, qualification, and verification activities across manufacturing, packaging, utilities, facilities, laboratories, and systems.
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Participate in defining validation/qualification strategies for product transfers and site product changes, including regulatory impact assessments.
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Review and approve Operational Qualification (OQ), Performance/Process Qualification (PQ), and Verification activities, along with associated SOPs.
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Review and approve analytical test method validation/verification reports, specifications, test methods, laboratory instrument qualifications, periodic reviews, risk assessments, commissioning documentation, installation certifications, and master batch records for manufacturing and packaging.
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Coordinate Change Requests (CRs) for qualified production records, equipment, systems, and facilities, including review, tracking, safekeeping, and closure of CRs.
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Assess the regulatory impact of proposed changes and ensure completeness of documentation prior to approval.
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Support PCF sponsors in preparing change requests by providing regulatory documentation.
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Create and revise export profiles for assigned products.
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Support activities related to new R&D products, including change controls, development, and validation documentation.
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Contribute to the APR process.
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Review documentation and change controls related to shipping labels and artwork.

Requirements

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Bachelor’s or Master’s degree in Chemical Engineering, Pharmaceutical Technology, or a related scientific field.
Proven experience in validation, qualification, and verification within a pharmaceutical manufacturing environment.
Strong knowledge of current Good Manufacturing Practices (cGMP) and other regulatory requirements.
Experience with Change Control processes, regulatory impact assessments, and cross-functional coordination.
Excellent skills in reviewing, auditing, and writing technical documentation.
Ability to manage multiple projects and prioritize tasks effectively.
Strong analytical, problem-solving, and communication skills.
Proficient in MS Office applications (Word, Excel, PowerPoint, etc.).

Nice to Have

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Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.