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Document Control Specialist

Overview:

Document Control Specialist will be responsible for managing all GMP controlled documents and records at the STA Pharmaceutical US LLC San Diego facility. Controlled documents may include SOPs (Standard Operating Procedures), batch records, QC test data, weekly monitoring charts, memos, policies, and training records. The candidate will be interacting with cross-functional groups such as Quality Control, Regulatory Affairs, Clinical, Chemical Development, Chemical Engineering, and Material Management.

Responsibilities:

  • Process all Document Control Requests (DCR’s), route and track the document review, approval and distribution.
  • Review document drafts for grammar, spelling and formatting and making corrections as needed for making documents effective for use.
  • Issue hardcopies of effective documents as distribute to Dept. Document Control personnel and update QA binders with current versions
  • Maintain electronic folders of drafts, edits and approved/effective documents.
  • Organize and maintain a filing systems for paper-based GMP controlled documents such as SOPs (Standard Operating Procedures), Master batch records, QC test data, weekly monitoring charts, memos, policies, and training records.
  • Support scanning, file creation and maintenance to upload controlled documents in the QA database.
  • Ensure all training is completed and the training records are entered the database.
  • Assign batch numbers, deviation, non-conformance, corrective actions and material specification numbers and maintain a log of each for completion within a specified time frame.
  • Maintain material lot files, databases, and spreadsheets.
  • Train, support and advise end users on the Document Management System requirements and workflows.
  • Assist with planning of internal audits, supplier audits and regulatory audits to ensure compliance current practices.
  • Send out documents for periodic review requests to department heads
  • Assist with or perform internal and external audits and in improving QA systems.
  • Maintain electronic folders of drafts, edits and effective documents.
  • Maintain and update company shared drive with effective/approved QA controlled documents.
  • Assist with off-site document archival per company policies.
  • Assist with other company administrative tasks as needed.

Qualifications:

  • Associated degree in life science area with at least 5 years of GMP document control experience, strong organization skills and attention to detail.
  • Understanding of documentation control systems associated with a biopharmaceutical manufacturing industry.
  • Expertise with MS Word, Excel, Office software.
  • Excellent organizational skills and attention to detail.
  • Effective communication (both oral and written) required to interact with
  • Analytical Development, Operations and Chemical R&D to accomplish goals.
  • Must be able to lift a minimum of 50 pounds and be able to bend, reach, stretch,      climb ladders, and work in tight spaces. Must be able to stand for long periods of time

 

Equal Opportunity Employer Minorities/Women/Veterans/Disabled