Robert Half International Quality Assurance Specialist in Newburyport, Massachusetts
Proactively perform Quality Assurance function in full compliance with current Good Manufacturing Practices applying regulations ICH Q7 and 21 CFR 211.
Consistent contribution to daily Quality Assurance operations, including but not limited to the following:
o Product release, including data and batch record review
o Review, editing and approval of controlled quality documentation
o Quality investigations
o Review of analytical method development and validation
o Change control, including documentation, equipment and process changes
o Inspection / internal audits of the facility to ensure real-time GMP compliance
o Supplier Qualification, including external auditing as needed
o Corrective and Preventive Action program
o Customer Complaints
o Training program
Assist QA management in efforts at continuous improvement of the quality program, including but not limited to the following:
o Advocate for quality compliance throughout the organization
o Periodic review of critical quality systems
o Report quality metrics / trending
Take a leadership / ownership role in support of one or more critical quality systems, including but not limited to the following:
o Training: develop and perform training opportunities for PCI personnel in critical quality systems, such as LIR, QI and CAPA
o Investigations: serve as lead for systemic quality investigations; mentor PCI personnel in growth of investigational skills
o Process Validation: serve as PCI subject matter expert for validation of manufacturing, analytical or cleaning processes
o Bachelor of Science in Chemistry, Biochemistry, Industrial Pharmacy or related scientific field, or foreign equivalent degree, or comparable level of technical training through formal education and/or industrial experience.
o 2 - 5 years’ experience in a cGMP quality, regulatory, and/or chemical manufacturing environment, with applied knowledge of GMP principles across quality disciplines, including but not limited to: Change Control; Training; Investigations; CAPA; Supplier
o Qualification; ICH stability studies; Method and/or Process Validation.
o Advanced demonstrated knowledge and proficiency in at least one of the following aspects of pharmaceutical operations:
o Analytical services, including equipment operation, laboratory data review, and material testing technologies (e.g. HPLC, GC, FTIR, KF, UV, TOC, wet chemistry)
o Manufacturing, including batch processing, equipment maintenance and calibration, batch record review
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Questions? Call your local office at 1.888.490.4154. All applicants applying for U.S. job openings must be authorized to work in the United States. Benefits are available to temporary professionals. Visit https://roberthalf.gobenefits.net/ for more information.
Robert Half International
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