Maintain the documentation and training quality systems to ensure Affymax is
in compliance with applicable regulatory requirements. Maintain GXP controlled
document system and records archival. Assist in the implementation of the EDMS
system. Assist in the coordination of internal GMP training for Affymax employees
and maintaining training records. Position reports to the Associate Director,
QA Compliance.
- Develop, operate and maintain the Document Control System to create and
maintain GXP controlled documents including: SOPs, forms, specifications,
protocols, reports and related documents. Support department authors in document
creation and revisions.
- Manage the QA GXP documentation database to assure accurate tracking and
retrievability of documents. Transmit and track documents/revisions to CMO's
and partners.
- Assist in developing, validating and implementing the EDMS. Write test scripts
and determine document process flow. Become a super user for the Quality Assurance
Department.
- Convert to and manage the EDMS system for GXP documents; ensure accuracy
and integrity of the validated EDMS, assign document numbers and coordinate
the approval process.
- Develop templates for controlled documents in coordination with the document
users.
- Assist authors in tracking documents through review and approval process.
Work with departments to ensure documentation is released on time. Track biennial
document reviews.
- Write and revise standard operating procedures (SOPs) to establish and improve
quality systems.
- Train employees and provide guidance on document format, content, control
and the EDMS system.
- Coordinate documents for PAI inspection by preparing and identifying needs
and by compiling documents and reports.
- Oversee archival of GXP hardcopy documentation and retrieval for internal
users and regulatory or other inspections.
- Perform and publish periodic metrics related to documentation and training
systems.
- Maintain the training records & database for GXP employees.
- Assure new GXP employees are entered into the database and track annual
training file reviews by the department heads.
- Perform other related duties to support QA team members as defined by management.
- Bachelors/Masters Degree in a relevant scientific discipline; minimum of
5 years in a GMP pharmaceutical environment including 3 years in QA.
- Excellent word processing skills. Experience in MS Word, MS Excel, visio
and MS Access required.
- Familiarity with EDMS systems strongly preferred.
- Superior attention to detail, accuracy, completeness and organization.
- Able to handle changing priorities to meet project team goals and timelines.
- Works independently with little supervision.
- Must maintain a flexible and customer-oriented approach with internal departments
and a collaborative and constructive manner with external partners.
- Proven technical writing/editing skills and problem-solving ability.
- Dynamic, team-oriented and interested in professional growth.
Affymax, Inc.
Human Resources
4001 Miranda Avenue
Palo Alto, CA 94304
careers@affymax.com
