- Salary
- $65+
- Location
- Boston, MA, US
- Workplace
- Onsite
- Type
- Contract
- Department
- Operations
- Seniority
- Manager
- Closing date
- Today
- Source
- iCIMS
Description
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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No C2C or Third-Party Vendors