Biotech Quality Document Control Specialist (Contract )

Precision Life Sciences - Boston, MA

Precision Life Sciences is seeking a contract, Quality Assurance Documentation Specialist for our client in the life science / biotechnology industry. This position will be responsible for partnering with cross-functional team members to ensure compliance with GxP documentation. The QA Documentation Specialist must have experience in authoring, editing, reviewing, evaluating, and maintaining documents in a GxP environment. This position will implement processes and systems associated with document management to align with quality and business objectives.

This role has responsibility for:

  • Maintenance and archiving of documentation associated with the Quality Management System
  • Policies and SOPs:
    • Tracking of training documentation
    • Initiation, Maintaining and communicating annual training plans
  • Audits and Vendor Management
    • Maintaining vendor qualification list and tracking vendors
    • Maintaining audit documentation
  • Tracking CAPAs
  • Supporting health authority inspections

Education

  • Bachelor’s degree

Work experience:

  • 2-3 years of relevant experience in pharmaceutical/biotech companies.

    Required qualifications

  • Detail-oriented and self-motivated.
  • Experience in working with different people from various cultures.
  • Excellent (English) language skills, oral and in writing.
  • Excellent communication (interpersonal, verbal, and written) and collaboration skills
  • Proficient MS Office skills.

Preferred Qualifications

  • Experience in maintenance and implementation of quality systems and activities at all phases of the Product Lifecycle and knowledge of GxP regulations, particularly pertaining to quality systems requirements.

 

Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient. The individual will need to effectively partner with various stakeholders throughout the organization. The QA Document Specialist requires excellent organizational skills, attention to detail, diligence, and flexibility as well as the ability to prioritize responsibilities.



Posted On: Wednesday, July 27, 2022



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