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.
- 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.
- 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 email@example.com or call (562)495-3200 x 4 and visit our website at www.biophaseinc.com for additional job opportunities!!!