Manager/ Sr. Quality Specialist (Document Control)
HAYS

Job Info

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The end client is unable to sponsor or transfer visas for this position; all parties authorized to work in the US without sponsorship are encouraged to apply.

A Biotechnology Company is seeking a Manager/ Sr. Quality Specialist (Document Control) in Cambridge, MA.

Role Description

Looking for a Sr. Quality Specialist, to join their growing Quality group. In this role the individual will manage the Electronic Document Management System (EDMS), to ensure all record and documentation systems are in compliance with US and international regulations, laws, and guidelines. The Senior Quality Specialist will be accountable for management of the EDMS, as well as support training, audits and inspections, and continuous improvement.

• Manage the GxP Electronic Documentation Management Systems (EDMS)
• Coordinate and support the creation, revision, distribution, and maintenance of controlled documentation (i.e., SOPs, regulatory submission documents, trial master file documentation, etc.)
• Work directly with the QA and Regulatory departments and other departments to revise, issue and track controlled documents and records to meet timelines. Provide status updates and reminders when necessary.
• Ensures basic grammatical accuracy and completeness when revising documents.
• Oversee document change control processes
• Conducts internal audits of the electronic document management system and documents where needed to ensure compliance to applicable Policies and SOPs.
• Support client and regulatory (FDA, EMA), inspections when necessary.
• Compile and provide applicable metrics for periodic Management review.
• Promote a Quality Culture by supporting innovation, teamwork and efficiency within the organization.

Skills & Requirements

• Bachelor's Degree and +2 years of experience with Good Manufacturing Practices (GMPs) in the pharmaceutical, biologic or medical device industries
• Prior experience with an Electronic Document Management Systems and Trial Master Files
• Experience with the establishment of an eTMF using the Trial Master File Reference Model
• Microsoft Word and Microsoft Access experience
• Knowledge of both domestic and international GMP, GCP and other relevant regulations.
• A team player, who listens effectively and invites response and discussion
• A collaborator who communicates in an open, clear, complete, timely and consistent manner
Desired Experience and Skills:
• Two plus years prior experience with Veeva QualityDocs, Training and eTMF systems
• Clear understanding of the regulations and guidelines that govern Good Documentation Practices, as well as Electronic Records and Electronic Signatures.
• Two plus years prior experience with Regulatory documentation and Regulatory submissions

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the Information Technology industry and market trends . Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there's a position you really want, you're fully prepared to get it.

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Hays is an Equal Opportunity Employer.

Drug testing may be required; please contact a recruiter for more information.
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