Vertex Pharmaceuticals

Operational Area Quality Senior Specialist

Vertex Pharmaceuticals  •  $95k - $142k/yr  •  United States (Remote)  •  4 hours ago
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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

    Company Information

    Vertex is a global biotechnology company that invests in scientific innovation.

    Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

    Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com

    Vertex Pharmaceuticals

    About Vertex Pharmaceuticals

    Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases and have made significant advancements in multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continue to progress clinical and research programs in these diseases. We also have a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where we have deep insight into causal human biology, including acute and neuropathic pain, APOL1-mediated kidney disease, IgA nephropathy, autosomal dominant polycystic kidney disease, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency.

    Our global HQ is in Boston, and we have research and development (R&D) sites and commercial offices worldwide.

    Vertex is consistently recognized as one of the industry’s top places to work by Science Magazine, The Boston Globe, Boston Business Journal and the San Diego Business Journal. We have also earned a spot on TIME Most Influential Companies, TIME Best Inventions, and Fast Company Most Innovative Companies lists. Our research and medicines have received esteemed recognitions, including the Robert J. Beall Therapeutics Development Award, the Prix Galien, the Scrip Award and the Breakthrough Prize awards.

    Read our community guidelines: https://www.vrtx.com/vertexs-community-guidelines/

    Industry
    Biotech & Life Sciences
    Company Size
    5,001-10,000 employees
    Headquarters
    Boston, MA
    Year Founded
    1989
    Website
    vrtx.com
    Social Media