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Robert Half International Quality Assurance Specialist in Newburyport, Massachusetts

Description

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

Requirements

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

OfficeTeam, a Robert Half Company, matches professionals in the administrative field with remote or on-site jobs on a temporary and temporary-to-full-time basis. Whether you're a seasoned administrative pro or starting your career, we have options for you.

Our experienced staffing professionals can promote you to employers and advocate on your behalf. We provide access to top jobs, competitive compensation and benefits, and free online training. For more opportunities, get the Robert Half app and receive instant notifications when our AI matches your skills and experience with jobs.

When you work with us, you’re working with the best. has been recognized as one of FORTUNE’s “Most Admired Companies” every year since 1998 and was named to Forbes’ inaugural list of America’s Best Temporary Staffing Firms.

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.

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