Manager, Operational Quality - VCGT 897

Atrium; Boston (MA); Vor Ort; USD 90.000 - 103.000; Vollzeit

Zusammenfassung

Atrium is seeking an Operational Quality Manager to oversee QA for GMP manufacturing and testing, reviewing batch records, deviations, and environmental data to support product disposition.

The role requires leading investigations, change controls, and documentation reviews, with strong communication and prioritization skills in a fast-paced GMP environment. Onsite, M‑F, with hourly pay options.

Qualifikationen

• Bachelor’s degree in a scientific or allied health field with 5–7 years of relevant 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.

Aufgaben

• 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.

Kenntnisse

QA oversight

cGMP knowledge

Veeva

LIMS

Oracle

investigations

deviations

change controls

batch release

documentation review

clear communication

prioritization

Ausbildung

Bachelor's degree in science/health

Tools

Veeva

LIMS

Oracle

Jobbeschreibung

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.

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 By applying for this position, you agree to the Atrium Terms and Conditions and you direct Atrium to share your application materials, which may include your CV/Resume, email address or phone number, with Vertex. For more information on how Vertex handles your personal data related to your job application, please see Vertex’s Careers Privacy Notice. Agreeing to the Atrium Terms and Conditions, includes permission to use the email address and mobile phone number you provide during the application process or throughout the duration of your prospective or actual employment to notify you of job openings, profiles, articles, news, and other employment-related information, as well as to notify you of special promotions or additional products and services offered by us or our affiliates and partners (Atrium Alerts). Atrium Alerts may be sent by email, phone, or text message. Your personal information will be safely stored within the Atrium & Vertex databases. Atrium does not sell your personal information to third parties. Text message and data rates may apply. To OPT OUT of text messaging or to modify your communication preferences for Atrium Alerts at any time, please contact Atrium at [e-mail]. 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 [e-mail]. Please include the job title in the subject of your email.