Quality Control Scientist (contract)

Location
Palo Alto, California, United States
Posted
Jun 25, 2021
Ref
108995056
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Vaxcyte is looking for an energetic and talented individual to join Vaxcyte's Vaccine Product Development organization as a contractor Quality Control Scientist within Analytical Development Quality Control department. The primary function of this contract position is to perform data review and compilation for all activities related to method transfer, qualification, validation and testing of our conjugate vaccine products. This position reports to the Associate Director of Method Transfer and Quality Control

Responsibilities:

• Data review and compilation for release and stability

• Data entry into a stability database and support data analysis of stability trends. Recognize aberrant test results or adverse trends and report them to stability management in timely manner

• Review of data from Contract Testing Labs against specifications and generation of CoA/CoT for critical reagents, intermediates, drug substance and drug product

• Raw data review for method validation and transfer

• Raw data review of QC contract lab data to support transfer of manufacturing process

• Compliance review of characterization data

Requirements:

• 5-7 years of industry experience in a QC GMP environment.

• Technical Knowledge of drug cGMP, pharmaceutical industry language.

• Demonstrated success in working in a team/collaborative environment

• Good organizational skills, strong ability to multi-task and be able to organize his/her own work with minimal oversight.