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System One QA Documentation Control II in Waltham, Massachusetts

Title: QA Documentation Control II

Location: Waltham, MA

Schedule: Mon-Fri; 8am-5pm

Type: Direct Hire

Start date: ASAP!

Responsibilities:

  • Works with subject matter experts, area managers and QA-Compliance personnel to properly convert documentation into the final written form and ensure the appropriate document approvals are obtained prior to documentation becoming effective

  • Thorough understanding and working knowledge of processes, procedures and systems in the department/ areas of responsibility

  • Prepares and publishes approved documentation in a timely manner to meet established deadlines (paper and electronic)

  • Maintains related database systems, if applicable, logs and complete forms/records, as required

  • Process requests and generates labels and batch records for production

  • Assist and supports On-Boarding Training

  • Mentor and Development Document Control QA Associate, I personnel

  • Support Customer Audits

    Requirements:

  • BS degree in Biological Science or other science related discipline

  • Minimum of 2-5 yrs. exp. in Document Control in an ISO 9001 certified Quality Management System or equivalent

  • Some sort of exp. training others on QA Doc. control (would assist in training new entry level hires)

  • Working knowledge of documentation functions within a cGMP or ISO regulated environment is preferred

    Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.

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