Quality Assurance Coordinator

3 weeks ago

Boston, United States Vertex Pharmaceuticals Full time

Job Description:

The Quality Assurance Coordinator provides administrative and coordination support for CMC Small Molecule Vendor Management processes with a high degree of independence and is adept at troubleshooting problems to create and execute improved internal procedures and to ensure compliance with Vendor Quality Management procedure requirements. Completes work in a resourceful, self-sufficient manner and is able to design alternative approaches to achieve desired outcomes. This role is responsible for providing coordination and support of Vendor Management processes within CMC Quality. This position reports to: Director, Small Molecule CMC Compliance Vendor Quality Management.

The ideal candidate will have strong data base management skills, Veeva experience, Quality events, reporting, CAPAs processing activities, as well as experience in Quality Assurance and ERP/QMS systems.

KEY RESPONSIBILITIES:

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

  • Conducts follow up with risk owners to maintain risk logs and ensures the system information (e.g., criticality, GxP type, business owner) for each GxP system is accurate in the Change Management Coordinates contracts and agreements; assists with execution of Purchase Orders (PO)/Requisitions, and conducts follow-up on approvals; distribution of PO; troubleshoots vendor payment issues
  • Conducts follow-up on Confidentiality and Disclosure Agreements
  • Coordinate Vendor Change Notification (VCN) meetings and initiate Change Requests in VeeQMS. Monitor the Vendor Management centralized eMail inbox for VCNo
  • Create Change Request in VeeQMSO Escalate issues, if required
  • Distributes/-posts SOPs to external parties per approved process
  • Facilitates SOPs through electronic document management system (EDMS)
  • Maintains action logs, approved vendor list (AVL), templates and trackers, and revisions and uploading/routing of SD documents
  • Performs Data Entry into GxP Regulated Systems as required
  • Manages events/CAPAs in electronic quality management system (EQMS), including data entry, tracking, and follow-ups with Owners to drive completion
  • Provide support for Change Management related to Vendor Quality Management
  • Generate CMC monthly PSMF Report for QST
  • Coordinate the quarterly revision of the documents, participate in triage meetings and update to Vendor List (SD-02386, SD-02387, SD-15144, and SD-45582)
  • Coordinate the annual GMP Certificate check and routine vendor license/certificate verification (RPA)
  • Request copies of GMP certificates, WDA and GDP from vendorso Complete monthly reconciliation of RPA reports to SD -39195
  • Ensures that the SOPs, SDs and WI associated to the Vendor Management Program are current.
  • Performs Archival of QA Records in EDMS and files documents to Sharepoint (e.g., vendor records) Schedules and coordinates meetings, including vendor meetings (e.g., pre audit, debrief, etc.)
  • Supply Chain Map verification against approved vendor list (AVL) and VeeQMSProviding power user support for the VeeQMS Organizational Object
  • Support Project Management activities
  • Other tasks as assigned by Management


MINIMUM QUALIFICATIONS:

  • Bachelors degree and 0 3 years of relevant work experience in the Biotech or Pharmaceutical industry, or relevant comparable background

PREFERRED QUALIFICATIONS:

  • Proficient computer skills, including Microsoft Office Suite (Word, PowerPoint, and Excel)
  • Strong interpersonal and communication skills
  • Strong organizational and time management skills; Ability to self-direct and manage individual projects
  • Critical thinking, with exceptional ability to learn new skills
  • Energetic, curious, and creative; eager to tackle new projects and ideas
  • Attention to detail, flexibility and ability to manage multiple activities to expected deadlines
  • Strong work ethic and tenacity
  • Planning and coordination skills


Pay Range:

$35-$38/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

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