QA Document Control in Richmond, CA at Apex Life Sciences

Date Posted: 4/4/2018

Job Snapshot

Job Description


JOB SUMMARY:

This position is responsible for all aspects of the GxP Document Control function. The position requires daily management of documentation including work processing, deployment of the document management system, archiving and retrieval of documentation. The position will have responsibility for deployment of the GxP training program to all necessary functions.

ESSENTIAL FUNCTIONS:

  • Maintain and manage GxP documentation, including batch records, testing records and other relevant production documents. Organize, scan, file, label and index manufacturing documents and testing records for electronic filing and paper hard copy storage. Manage GMP reports and records.
  • Support preparation and revision of Sangamo SOPs, Material Specifications and other manufacturing and QA documents. Support review of raw material specification, buffer preparation records, batch production records, labels and other manufacturing documents from CMOs and CROs.
  • Maintain pre-clinical and development protocols and study reports.
  • Provide word processing support to GxP staff for protocol, report and SOP writing.
  • Support Quality Assurance in the deployment of the training program to all GxP employees.
  • Issue and maintain quality system tracking mechanisms, logs and job specific metrics.

EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:

  • Bachelor of Science degree or equivalent work experience
  • Relevant document control management experience in a cGMP/FDA regulated environment such as manufacturing, QC or QA. (2 – 4 years for Associate; 5+ years for Senior Associate).
  • Good knowledge & application of FDA regulatory requirements and industry standards related to cGMP document management.
  • Must be able to help implement and maintain a robust documentation system (EDMS and LMS).
  • Excellent computer skills and proficient in MS Word and Excel.
  • Experience with electronic document management systems

OTHER REQUIRMENTS:

  • Excellent written and verbal communication skills
  • Great attention to detail and skill in reviewing systems and documents for accuracy.
  • Strong organizational and time management skills
  • Must be able to work as a team player with minimal supervision both internally within Quality and on multi-functional projects.
  • Other duties may be assigned as required by business needs.

The above reflects management’s definition of essential functions for this position, but does not restrict the tasks that may be assigned. The above duties are representative only; management may assign or reassign duties and responsibilities to this position at any time.