Quality Systems Senior Specialist

1 week ago

Boston, United States Vertex Pharmaceuticals Full time

Job Description:

The Quality Systems Sr. Specialist is an experienced technical resource in the principles and application of quality systems and compliance. The Quality Systems Sr. Specialist coordinates or executes activities on projects and takes a role in the execution and improvement of processes.

Key Responsibilities:

The responsibilities of this position may include, but are not limited to, the following:

  • Responsible for supporting local Quality system oversight, metrics, and improvement including change control, events, CAPA, and risk management.
  • Responsible for supporting functional quality oversight for Change Control Management Program including change control board/triage process.
  • Responsible for supporting follow up on any Quality Leadership Team (QLT) meeting action items assigned.
  • Coordinates and/or supports the monitoring, interpretation, and communication of QMS processes and metrics requirements including remediation plans.
  • Collaborates with internal and external business partners to resolve quality issues to ensure compliant solutions.
  • Provides hands-on support in the day to day management of data collection systems and control within the GxP Quality Management System using digital solutions.
  • Assists with Quality and Risk Management initiatives and activities to drive prioritization and in-support continuous improvement across VCGT QMS/Compliance processes.
  • Assists Change Control, deviation, and CAPA owners with ensuring compliance to change procedure requirements.
  • Supports internal audit or external audit programs.
  • Identifies and implements continuous improvement to improve processes and make them efficient and scalable.

Minimum qualifications:

Knowledge and Skills:

  • Knowledge of both the conceptual and practical application of cGMPs in a pharmaceutical setting; knowledge of global GMP requirements and support of GMP manufacturing.
  • Ability to work in a fast-paced environment and meet quality, accuracy, and timeliness objectives.
  • Experience implementing projects and continuous improvement initiatives within stated objectives and timelines; effectively applies project management processes / tools to lead meetings, assist with project planning, and facilitate completion of tasks
  • Ability to represent the Quality unit in cross-functional teams.
  • Ability to communicate cross-functionally and gain alignment around a proposed action.
  • Demonstrated ability to work independently to provide QA support for projects.
  • Demonstrated ability to evaluate quality matters and recommend solutions leveraging technical experience and judgement.
  • Experience with event investigations, Root Cause Analysis (RCA), and CAPA.
  • Experience with electronic document management systems (e.g., QDoccs, Trackwise, Veeva).

Education and Experience:

  • Bachelor's degree in a scientific or allied health field (or equivalent degree).
  • Typically requires 3 years of experience, or the equivalent combination of education and experience.


Pay Range:

$45-$55/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 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 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

  • Senior Service Specialist

    5 days ago

    Boston, United States EPIQ Systems Full time

    A Senior Service Specialist provides various administrative support to our clients which may include; copy, print, mail, hospitality, facilities and receptionist services. RESPONSIBILITIES Mail Services includes metering, sorting, and distributing m Specialist, Service, Senior, Hospitality, Technology, Retail

  • Quality & Patient Safety Specialist (RN)

    9 minutes ago

    Boston, United States Boston Medical Center Full time

    POSITION SUMMARY: The Quality & Patient Safety Specialist plays a role in supporting the development, implementation, management and sustainment of an organization-wide system of quality and safety. Working with the Quality & Patient Safety team and organizational cross-functional teams, the Quality & Patient Safety specialist will support activities to...

  • Senior Histology Specialist

    Found in: Lensa US P 2 C2 - 2 weeks ago

    Boston, United States CareerBuilder Full time

    Senior Histology Specialist Immunohistochemistry Day Shift We're offering a generous sign on bonus of $10,000 come you to our team. Recognizing and valuing exceptional talent, we're eager to discuss the exciting details of this bonus during our interview process. Assists in the overseeing of the Immunohistochemistry laboratory of the Histopathology Unit....

  • Supplier Quality Specialist 3

    1 week ago

    Boston, United States Boeing Future of Flight Full time

    Supplier Quality Specialist 3 (Contract) Contract (12 months) Published 2 days ago Procurement Processes Quality Systems Process analytical skills Quality Specialist - Eastern MA Plans and conducts audits and assessments of supplier's systems, processes and products. Documents and reports audit and assessment results. Inspects or verifies products for...

  • Senior Project Manager

    1 week ago

    Boston, United States National Institute for Children's Health Quality Full time

    Job DescriptionJob DescriptionOrganization Overview:The National Institute for Children's Health Quality (NICHQ) is a mission-driven nonprofit dedicated to driving dramatic and sustainable improvements in the complex issues facing children's health. We provide deep expertise in building and managing effective change strategies that align partners and...

  • Quality & Patient Safety Specialist (RN)

    2 weeks ago

    Boston, United States Jobvous Staffing Solutions, LLC Full time

    Job DescriptionJob DescriptionJob DescriptionPOSITION SUMMARY:The Quality & Patient Safety Specialist plays a role in supporting the development, implementation, management and sustainment of an organization-wide system of quality and safety. Working with the Quality & Patient Safety team and organizational cross-functional teams, the Quality & Patient...

  • Quality & Patient Safety Specialist

    Found in: Resume Library US A2 - 2 weeks ago

    Boston, Massachusetts, United States Jobvous Staffing Solutions, LLC Full time

    Job DescriptionPOSITION SUMMARY: The Quality & Patient Safety Specialist plays a role in supporting the development, implementation, management and sustainment of an organization-wide system of quality and safety. Working with the Quality & Patient Safety team and organizational cross-functional teams, the Quality & Patient Safety specialist will support...

  • Senior Director BIS Quality

    2 days ago

    Boston, United States Blackwomenintech Full time

    As argenx continues to grow and evolve, we are looking for a Senior Director BIS Quality. The Senior Director BIS Quality is responsible for both the strategic direction as well as the day-to-day operations and coordination of all activities relating to the argenx Computer Systems Assurance (CSA) Process. This includes GxP systems, Regulated systems and...

  • Sr GMP Operations Specialist

    1 week ago

    Boston, United States Connexion Systems & Engineering Full time

    Job DescriptionJob Description Job Title: GMP Operational Quality Sr Specialist Location: Hybrid Boston Salary range: $50-60/hr Nice to have qualifications: · Provides QA review of the GMP data in support of release of commercial product as required. · Collaborates with internal and external business partners to resolve quality issues to ensure compliant...

  • Quality Assurance Sr. Specialist

    3 days ago

    Boston, United States Katalyst Healthcares and Life Sciences Full time

    Description:seeking a Quality Assurance Sr. Specialist for real time on the floor quality oversight and lot disposition of Small Molecule GMP manufacturing facility at Moderna Inc. This position will be based in our cGMP Small Molecule Manufacturing site in Cambridge, MA. The individual in this role will be part of a cohesive team responsible for supporting...

  • GMP Operational Quality, Senior Specialist

    Found in: Resume Library US A2 - 1 week ago

    Boston, Massachusetts, United States Vertex Pharmaceuticals Full time

    Job Description: The GMP Operational Quality Senior Specialist works with a high degree of independence to provide QA Analytical support for release and stability program for commercial products.   The GMP Operational Quality Specialist executes routine tasks and activities in support of QA Analytical function.   KEY DUTIES AND...

  • Quality Assurance Specialist

    2 weeks ago

    Boston, United States BioTalent Full time

    IntroductionWe are working with an innovative medical device company going through tremendous growth. They are seeking a Quality Assurance Specialist with a focus on CAPA and Root Cause Analysis. This role will offer you· Accelerated career growth on a team with a proven track record for internal growth.· Work on state-of-the-art medical devices on the...

  • Quality Assurance Specialist

    Found in: Appcast US C2 - 2 weeks ago

    Boston, United States BioTalent Full time

    IntroductionWe are working with an innovative medical device company going through tremendous growth. They are seeking a Quality Assurance Specialist with a focus on CAPA and Root Cause Analysis. This role will offer you· Accelerated career growth on a team with a proven track record for internal growth.· Work on state-of-the-art medical devices on the...

  • Quality Assurance Specialist

    Found in: Appcast Linkedin GBL C2 - 2 weeks ago

    Boston, United States BioTalent Full time

    IntroductionWe are working with an innovative medical device company going through tremendous growth. They are seeking a Quality Assurance Specialist with a focus on CAPA and Root Cause Analysis. This role will offer you· Accelerated career growth on a team with a proven track record for internal growth.· Work on state-of-the-art medical devices on the...

  • Senior Director of Human Resource Systems

    1 week ago

    Boston, United States Tandym group Full time

    A biopharma company in Massachusetts is looking to add a new Senior Director / Head of Human Resource Systems to their team. In this role, the Senior Director / Head of Human Resource Systems will be responsible for acting as a key member of highly collaborative HR and corporate teams with responsibility for Human Resource management systems, data and...

  • Senior System Engineer

    Found in: Appcast US C2 - 1 week ago

    Boston, United States Broadreach Executive Search Full time

    The Senior Systems Engineer will be responsible for the overall management and maintenance of key infrastructure systems and services. As a key member of the Global Infrastructure Team, the Senior Systems Engineer will have responsibility to provide first class service to our internal customers by planning and delivering on tactical technology projects and...

  • Senior System Engineer

    Found in: Appcast Linkedin GBL C2 - 1 week ago

    Boston, United States Broadreach Executive Search Full time

    The Senior Systems Engineer will be responsible for the overall management and maintenance of key infrastructure systems and services. As a key member of the Global Infrastructure Team, the Senior Systems Engineer will have responsibility to provide first class service to our internal customers by planning and delivering on tactical technology projects and...

  • Senior Benefits Specialist

    7 days ago

    Boston, United States Randstad Full time

    Senior Benefits Specialist Pay Rate: 55-65 per hour 100% Remote • Bachelor's degree in Human Resources, Business Administration, or a related field. • 7-10 years of relevant experience with benefits and 401(k) administration. • 1-2 years of Audit experience (either external or internal). Where you’ll work: Remote-centric; preferably, Eastern Time...

  • Physical Security Systems Application Specialist

    Found in: Talent US C2 - 1 week ago

    Boston, United States Mass General Brigham Full time

    Physical Security Systems Application Specialist-(3284399) Description GENERAL SUMMARY/ OVERVIEW STATEMENT:Summarize the nature and level of work performed. We are in search of a seasoned and highly proficient Physical Security Systems Application Specialist to join our dynamic team. The ideal candidate will assume responsibility for supporting and...

  • Senior Systems Engineer

    Found in: beBee S US - 4 days ago

    Boston, United States HarbourVest Partners Full time

    Job Description Summary For over forty years, HarbourVest has been home to a committed team of professionals with an entrepreneurial spirit and a desire to deliver impactful solutions to our clients and investing partners. As our global firm grows, we continue to add individuals who seek a collaborative, open-door culture that values diversity and...