Sr. Quality Assurance Specialist – Operational Quality, External Manufactur at Vertex Pharmaceuticals Incorporated - Australia

Boston, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

12 Apr, 26

Salary

62.0

Posted On

12 Jan, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, cGMP, GMP Manufacturing, GMP Laboratory Operations, Event Investigations, Deviations, Change Controls, Analytical Laboratory Testing, Attention to Detail, Communication Skills, Document Management, Batch Records, Veeva, LIMS, Oracle

Industry

Biotechnology Research

Description

Job Description The Operational Area Senior Quality Specialist will provide QA support for manufacturing operations, analytical laboratory operations and materials management for external manufacturing programs at VCGT. This role will review batch data, including batch records, deviations, in-process data, EM data, QC release and stability testing and other quality systems documentation as needed in support of product disposition. Key Responsibilities: • Reviews master batch records and provide customer approval for quality tasks for externally manufactured products• Reviews analytical laboratory testing data including method validation and QC testing 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.• Reviews and approves 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.• Escalates critical and major findings to Quality management. Qualifications: • Bachelor’s degree in a scientific or allied health field with 3-5 years of relevant work experience, or relevant comparable background.• Knowledge of cGMP's in a pharmaceutical setting• Experience providing QA support and oversight of GMP manufacturing and GMP laboratory operations.• 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 Pay Range $55-$62/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 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 (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 privacyadministrator@atriumstaff.com. 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

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Responsibilities

The Senior Quality Specialist will provide QA support for manufacturing and analytical laboratory operations for external manufacturing programs. Key tasks include reviewing batch data, approving quality tasks, and managing the batch release process.