Job Description

The Operational Quality Manager provides QA oversight for GMP manufacturing and testing operations. The role reviews batch records, deviations, in-process and environmental monitoring data, QC release and stability testing, and related quality documentation to support product disposition.

Key Responsibilities

• Review master batch records and approve quality tasks for manufactured products.
• Review in-process, environmental monitoring, and QC data, including certificates of analysis, and provide required quality approvals.
• Perform final review of executed batch records and critical systems documentation, including certificates of analysis and conformance, in accordance with procedures.
• Confirm all required documentation is complete and acceptable before product or system release.
• Support investigations, deviations, and change controls within manufacturing operations.
• Support day-to-day management of the batch release process.
• Communicate proactively with internal and external partners and management.
• Maintain and archive records so documents are readily available and retrievable.
• Prepare metrics and data for program reporting.
• Escalate critical and major findings to Quality management.
• Collaborate with external vendors to review GMP documentation supporting product disposition.

Qualifications

• Bachelor’s degree in a scientific or allied health field and 5–7 years of relevant experience, or an equivalent combination of education and experience.
• Knowledge of current Good Manufacturing Practices (cGMP) in a pharmaceutical environment.
• Experience providing QA oversight for GMP manufacturing and testing operations.
• Experience reviewing GMP documentation from external vendors.
• Experience leading investigations, deviations, and change controls.
• Experience with systems such as Veeva, LIMS and Oracle.
• Strong attention to detail and effective written and verbal communication skills.
• Ability to manage competing priorities and timelines in a fast-paced environment.

Contract Length: 12 months

Pay Range

$65/hr.-$75/hr.

Shift/Hours

Monday–Friday, onsite.

Requisition Disclaimer

This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements

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If you do not agree with the Atrium Terms and Conditions, you can still complete your application for this position by emailing your resume to our team at tempstaffing@vrtx.com. Please include the job title in the subject of your email.

No C2C or Third-Party Vendors