Conduct 100% data review in support of QC method validations; methods are currently
used to release clinical material; report to Associate Director, QC Stability
& Compliance.
- Evaluate and review data generated in support of method validation, insuring
that results are complete, accurate and in conformance to specifications.
Review validation reports and insure that experiments are conducted in accordance
with approved protocol. Methods being validated include RP-HPLC and ELISA
assays.
- Review validation protocols and insure that the experimental design is adequate
to achieve the stated goal.
- Review deviations generated while conducting experiments described in validation
protocols.
- Revise QC SOPs written in the group for compliance and consistency with
other SOPs.
- Send samples to contract testing laboratories and document results.
- Assists in maintaining the inventory of laboratory reagents and supplies.
- BS in Chemistry, Microbiology, Biology or equivalent discipline.
- 5 years industrial QC laboratory experience in the pharmaceutical, biopharmaceutical
or medical device industry.
- Hands on experience with HPLC assays and ELISA binding assays
- Knowledge of GMP guidelines.
- Good computer skills.
Affymax, Inc.
Human Resources
4001 Miranda Avenue
Palo Alto, CA 94304
careers@affymax.com
