Review master and executed API batch records. Review data, protocols and reports
to support product disposition, stability studies and clinical studies. Conduct/support
investigations and resolve quality related questions. Perform internal and external
audits. Assist in the development and implementation, of process validation
for API. Position reports to the Director of Quality Assurance.
- Perform batch production records and QC release data for API and drug product.
- Perform or assist in QA investigations (deviations and non-conformances)
for API and drug product with CMOs or QC/CTL.
- Write QA investigation reports.
- Perform batch labeling and packaging documentation reviews to ensure cGMP
compliance of clinical trial materials.
- Ensure cGMP compliance in raw material supply chain.
- Perform QA reviews of master batch production records.
- Perform QA reviews of stability test data and reports.
- Perform QA review of process validation protocols and reports.
- Perform QA reviews of method transfer/validation data and reports.
- Review product development documents, protocols and reports for adherence
to quality system and regulatory guidelines and requirements.
- Create and revise standard operating procedures (SOPs) to establish and
improve quality systems.
- Conduct internal audits of Affymax systems, activities and records to ensure
adherence to applicable GXPs and internal SOPs.
- Conduct external audits of suppliers, vendors, and manufacturers to ensure
compliance to applicable GXPs, regulatory requirements and guidelines.
- Bachelors/Masters Degree in a relevant scientific area with at least 3 years
experience in a GMP pharmaceutical environment; minimum of 2 years in QA.
- Demonstrated knowledge of US and EU regulations and guidelines related to
API and clinical trial materials.
- Process validation and method validation experience highly desired.
- Must have performed batch record and data review.
- Led deviation and non-conforming material investigations.
- Proven technical writing/editing skills and problem-solving ability.
- Able to handle multiple priorities to meet project team goals and timelines.
- Must maintain a flexible and customer-oriented approach with internal departments
and a collaborative and constructive manner with external partners.
- Dynamic, team-oriented and interested in professional growth.
- Computer proficiency with MS Word, MS Excel and MS Access.
- Knowledge of commercial scale chemical synthesis and purification desired.
Affymax, Inc.
Human Resources
4001 Miranda Avenue
Palo Alto, CA 94304
careers@affymax.com
