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System One Services Quality Systems Documentation Specialist III in Canton, Massachusetts

Quality Systems Documentation Specialist IIICanton, MA

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Type:Direct-Hire

Category:Scientific & Clinical

Job ID:221910

Date Posted:06/08/2021

Quality Systems Documentation Specialist III

Degree/Experience/"MUST HAVES":

  • Minimum of an AS Degree with 2+ yrs. exp. in GMP environment is required

  • Previous Documentation/Quality experience in Pharmaceutical/Medical Device industry

  • Willing and able to look at and do SOPs all day long

Duties/Responsibiltiies:

  • Maintain databases for Document Control inventory.

    • Maintain archival of all GMP records per established process.

    • Responsible for ensuring that records are maintained, secure, and retrievable throughout defined record retention periods.

  • Participate in the creation and/or review of Standard Operating Procedures (SOPs) for all projects.

    • Perform a thorough quality review of all SOPs for compliance, in addition to fixing format, grammar, etc.

    • Perform routing, review, and approval activities in Part 11 compliant electronic system.

    • Ensures the issuance of production batch records (MBR's), Nonconforming Material Reports (NCMR's), Deviations, GMP Investigations, MS item numbers, Part Numbers, and Out-of-specification Numbers.

    • Maintain databases for Document Control inventory.

Location:Canton, MA. area

Start Date:ASAP!!

Duration:Direct Hire

Hours:Mon-Fri; 8am-4pm

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