Client is seeking a Senior QC Associate for a contract position with a Global Biopharmaceutical Company located in Fremont, CA. This is a 12+ month contract opportunity. This role is assigned to a Quality Control functional area and is responsible for executing and coordinating analytical testing of bulk drug substances and drug products in a multi-product facility. The associate will perform duties under limited supervision according to standard operating procedures, adhering to cGMP and cGDP regulations, and will also train other associates and technicians on methods and processes.

Shift hours:

1st

Shift:

Mon-Fri, 8AM-5

PM Responsibilities:

Execute and coordinate analytical testing of bulk drug substances and drug products in areas such as HPLC/CE, Potency testing, Residual Impurities, and Microbiology Execute and coordinate Raw Material sampling and testing and sampling of clean rooms Coordinate routine-maintained activities and author quality/compliance documents (test methods, specs, SOPs) Perform duties under limited supervision according to standard operating and QC procedures Train other associates and technicians on methods and processes Execute three to five (3-5) analytical testing methods with different analytical principles independently Document work according to cGMP and cGDP, and report abnormalities and deviations in a timely manner Adhere to safety standards and maintain lab areas according to 5s standards Review and trend analytical data and compliance processes to identify out-of-trend results Coordinate work within the team and cross-functionally to resolve issues

Requirements:

High School Diploma with six (6) years of experience in cGMP regulated industry or equivalent OR Associate Degree with four (4) years of experience in cGMP regulated industry or equivalent OR Bachelor's Degree in a science or engineering related field with two (2) or more years of experience in cGMP regulated industry or equivalent Experience with performing analytical methodologies within different scientific principles relevant to Biopharmaceutical manufacturing Strong understanding of analytical chemistry and/or analytical testing as it applies to biopharmaceuticals Proven experience with technical review, analysis, and interpretation of scientific data Strong written and verbal communication skills Experience with computer-based systems and ideally experience with process control systems Previous experience reading and understanding SOPs/methods and documenting work applying cGMP/GDP standards Ability to work as part of a high performing team and collaborate effectively with staff Ability to work independently with very little supervision Desired skills:

Previous QC Experience Pay Rate:

Up to $41.51 per hour

Pay:

Up to $41.51 per hour Expected hours: 40.0 per week

Work Location:

In person