Operational Area Quality Senior Specialist

Vertex Pharmaceuticals Incorporated

$94K — $141K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor’s degree in a scientific or allied health field or equivalent experience
  • Experience providing QA support in GMP manufacturing
  • Proven ability to lead event investigations, Root Cause Analysis, and CAPA
  • Familiarity with Oracle, TrackWise, Veeva systems
  • Knowledge of current industry trends and technologies

Responsibilities

  • Review master batch records and approve quality tasks for externally manufactured products
  • Perform final reviews and determine documentation acceptability
  • Ensure all required documentation is present prior to product release
  • Review and approve investigations, CAPA's, and change controls for external programs
  • Support daily batch release management
  • Contribute to annual product quality reviews
  • Assist in quality audit preparation and participate in audits as needed
  • Maintain organized and retrievable document files
  • Assist with quality system data reviews and reporting
  • Escalate critical findings to management and monitor key performance indicators

Benefits

  • Comprehensive medical, dental, and vision plans
  • Generous paid time off including a summer and winter shutdown
  • Educational assistance programs including student loan repayment
  • Commuting subsidy and matching charitable donations
  • 401(k) plan with company matching
  • Flexible work arrangements with hybrid eligibility
Full Job Description

Job Description

General Summary:

The Operational Area Senior Quality Specialist will provide QA support of manufacturing operations, analytical laboratory operations and materials management for the external manufacturing programs at VCGT. This role will review batch data, including batch records, deviations, in-process data, EM data, QC release testing and other quality systems documentation as needed in support of product disposition.


Key Duties and Responsibilities:

  • Reviews master batch records and provides customer approval for quality tasks for externally manufactured products
  • Performs final review of executed batch and/or critical systems documentation and determines acceptability by using standard operating procedures
  • Ensures presence and acceptability of all required documentation prior to the release of the product and/or system.
  • Reviews and approves investigations, CAPA’s and change controls for external programs
  • Support the day to day management of the batch release process.
  • Support annual product quality reviews
  • Assist the facility in preparation for quality audits and participate in corporate audits and external inspections as needed.
  • Communicates proactively with internal and external partners and management.
  • Maintains files such that documents are readily available and easily retrievable.
  • Assists department with monthly/quarterly Quality System data review metrics and reporting
  • Escalate critical and major finding to Quality management and monitor key performance indicators in collaboration with Quality Systems and other GXP Operational areas.
  • Knowledge and Skills:

    Education and Experience:

  • Bachelor’s degree in a scientific or allied health field or the equivalent combination of education and experience
  • Experience providing QA support and oversight of GMP manufacturing operation
  • Experience successfully leading event investigations, Root Cause Analysis and CAPA
  • Experience with network-based applications such as Oracle, TrackWise, Veeva
  • Knowledge of current industry trends and ability to use the latest technologies
  • Pay Range:

    $94,600 - $141,800

    Disclosure Statement:

    The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

    At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations.  From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

    Flex Designation:

    Hybrid-Eligible Or On-Site Eligible

    Flex Eligibility Status:

    In this Hybrid-Eligible role, you can choose to be designated as: 
    1.    Hybrid: work remotely up to two days per week; or select
    2.    On-Site: work five days per week on-site with ad hoc flexibility.

    Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. 

    #LI-Hybrid

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