Manager , Operational Quality, External Manufacturing (VCGT)(Contract) 27669
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Job Location:
Boston, NH - USA
Monthly Salary:
$ 70 - 75
Posted on:
3 hours ago
Vacancies:
1 Vacancy
Job Summary
Job Description
- Reviews master batch records and provide customer approval for quality tasks for externally manufactured products
- Reviews analytical laboratory testing data including method validation QC testing and CoA issuance with providing customer approval for externally manufactured products
- Performs final review of executed batch and/or critical systems documentation including certificate of analysis / certificate of conformance and determines acceptability by using standard operating procedure
- Ensures presence and acceptability of all required documentation prior to the release of the product and/or system
- Assists with analytical investigations deviations and change controls for external programs
- Supports the day-to-day management of the batch release process
- Communicates proactively with internal and external partners and management
- Assists in the maintenance and archival of document management such that documents are readily available and easily retrievable
- Assists with metrics and data reporting pertaining to program reporting
- Escalates critical and major findings to Quality management
- Collaborate with external vendors supporting the review of external GMP documentation for product disposition
- Bachelors degree in a scientific or allied health field with 5-7 years of relevant work experience or relevant comparable background
- Knowledge of cGMPs in a pharmaceutical setting
- Experience providing QA support and oversight of GMP manufacturing and GMP laboratory operations with external vendors
- Experience working with external vendors on reviewing external GMP documentation
- Experience successfully leading event investigations deviations and change controls
- Experience with network-based applications such as Veeva LIMS and Oracle
- Strong attention to detail
- Effective communication skills both verbal and written
- Ability to work in a fast-paced environment manage priorities and maintain timelines for multiple projects
Pay Range
$70-75/hr
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 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 Vertexs 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
(collectively 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 .
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 Please include the job title in the subject of your email.
No C2C or Third-Party Vendors
Required Experience:
Manager
Key Skills
- Lean Manufacturing
- Six Sigma
- Continuous Improvement
- ISO 9001
- Lean Six Sigma
- Management Experience
- Manufacturing & Controls
- 5S
- Manufacturing Management
- Kaizen
- Chemistry
- Manufacturing
