Quality Specialist, Archive Management (Contract) 24980

The Quality Specialist, Archive Management is responsible for performing multiple activities in support of their group or clients under minimal supervision.  The Specialist applies technical proficiency and attention to detail in “troubleshooting,” as well as the ability to interpret and execute project plans and lead initiatives with minimal guidance.

This role is part-time

GENERAL RESPONSIBILITIES AND REQUIRED SKILLS:

• Presents a solid understanding of quality assurance concepts and practices
• Demonstrates knowledge of applicable regulations and the interpretation and application of regulations and compliance concepts related to document control
• Responsible for all GxP Archiving Activities and regulatory knowledge
• Presents a solid understanding of both digital and paper document control best practices
• Exercises independent judgment to optimize compliance procedures and identify opportunities for continuous improvement
• Able to manage and anticipate client expectations
• Displays effective communication skills (written and verbal), within their area(s) of expertise
• Demonstrates proactive thinking and actions
• Responsible for reviewing and authoring SOPs and Work Instructions, with minimal supervision
• Acts as a representative of their Quality division on assigned project sub-teams and/or task forces
• Demonstrates proficiency in influencing others within project teams regarding quality or compliance concerns
• Displays an ability to develop innovative ideas for solving problems
• Displays solid organizational and project management skills
• Has the ability to read and respond to audiences appropriately
• Performs other duties as assigned

KEY RESPONSIBILITIES:

• Recognized as a technical resource within their discipline; answering questions and requests related to the DMS (CMC, QA, System Downtime, etc) and incidents and service requests
• DMS Business Owner responsibilities
• Maintain GXP archives, including receipt, processing and storage of GXP records.
• Facilitate the lifecycle of controlled documents in the electronic document management system (document creation, revision, issuance, and obsolescence)
• CMC Documents (Master Batch Records, Analytical Methods, Specifications, etc.)
• QA Controlled Documents (Standard Operating Procedures, Work Instructions, etc.)
• Document Distribution (including batch record and logbook issuance)

• Interacts with internal and external customers and functional groups at various management levels to provide excellent customer service

REQUIREMENTS

• 3-5 years experience in QA and archive management
• Experience in Biotech or Pharmaceutical industry

$40-$45/hr

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

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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