Documentation Specialist

BioPhase Solutions specializes in recruiting top talented professionals for Southern California's Scientific community. We are currently looking for a Documentation Specialist to work for a leading Greater Los Angeles area bio pharmaceutical company.


Documentation Specialist


Responsibilities:
  • Maintain a document management system compliant with regulatory, quality, and company requirements.
  • Responsible for the management of all documentation and records issuance and archival processes to support clinical and commercial manufacturing.
  • Provides guidance and advice on approved procedures, standardization and requirements associated with the document management system.
  • Responsible for enhancing and maintaining the document change control system.
  • Executes the document change process so that only approved and validated changes are incorporated into effective product and process documentation.
  • Ensures accuracy by reviewing documents for completeness, proper authorization and impact to other quality systems.
  • Collaborates with cross-functional departments to ensure timely implementation of document change requests.
  • Issues effective documents including procedures, test methods, specifications batch documentation and labels.
  • Executes strategic initiatives to improve the document management system.
  • Investigates deviations against the document management system and develops effective corrective action plans.
  • Develops training content for document management processes and procedures.
  • Provides training to new staff on document management processes and procedures.
  • Support audits (internal, external) in order to verify that regulatory and quality requirements have been met.
  • Perform other duties as required.
     
Requirements:
  • Bachelor’s Degree.
  • Minimum 5 years of experience in a quality document management, quality engineering, validation, and quality assurance or quality systems.
  • Strong knowledge of GMP, SOPs and quality system processes. 
  • Proficient in MS Word, Excel, Power Point, Adobe Pro, and electronic document management systems (Document Locator, documentum, Veeva or equivalent).
  • Experience in pharmaceutical or bio-pharmaceutical field.
  • Education or training in cell culture and gene therapy manufacturing environment a plus.
  • Quality systems demonstrated working knowledge in areas such as document management, document change control audits, batch record and label issuance.
  • Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211). 
  • The standard work week for this position is M-F but occasional weekend work may be required.
 

Please send resumes to gavin@biophaseinc.com or call (562)495-3200 x 4 and visit our website at www.biophaseinc.com for additional job opportunities!!!
 

  • Location: Los Angeles County
  • Type: Contract
  • Job ID: HS56563813