Sr. QC Associate

LanceSoft•Fremont, CA

About The Position

The Sr. QC Associate works in an assigned QC functional or technical area, such as HPLC/Client, potency testing, residual impurities, physicochemical/drug product, microbiology/environmental monitoring, raw materials/cleaning validation and verification, or packaging testing. The role executes and coordinates analytical testing of bulk drug substances and drug products in a multi-product facility, along with raw-material sampling and testing and cleanroom sampling as applicable. Under limited supervision, the associate performs work according to standard operating and QC procedures and independently executes three to five analytical methods based on different analytical principles after receiving adequate training. The role coordinates routine maintenance and fundamental laboratory tasks, performs and reviews testing across multiple analytical technologies, reviews and trends analytical data and compliance processes, and authors routine quality and compliance documents. The associate documents work in accordance with cGMP and cGDP, follows site regulations and safety standards, reports abnormalities and deviations, and maintains laboratory areas to predefined 5S standards. The role identifies process anomalies and opportunities for improvement, resolves moderately complex method and testing issues, investigates data discrepancies, and collaborates across teams to implement appropriate solutions. It also maintains personal training compliance and trains associates and technicians on methods, processes, and compliance topics upon completion of trainer qualification.

Requirements

High school diploma and six years of experience in a cGMP-regulated industry or equivalent; or an associate degree and four years of such experience; or a bachelor's degree in a science- or engineering-related field and at least two years of such experience.
Experience performing analytical methodologies based on different scientific principles relevant to biopharmaceutical manufacturing.
Proficiency in three to five analytical methodologies, including technical review, interpretation, and trending as needed.
Strong understanding of analytical chemistry and/or analytical testing as applied to biopharmaceuticals.
Proven experience with technical review, analysis, and interpretation of scientific data.
Ability to concentrate on detail-oriented work in a complex technical environment with a quality and right-first-time mindset.
Strong written and verbal communication skills.
Experience with computer-based systems; experience with process control systems is ideal.
Ability to read and understand SOPs and/or methods and document work in writing according to cGMP/GDP standards.
Ability to collaborate effectively and work as part of a high-performing team.
Strong focus on executing non-routine analytical methods or processes.
Strong technical knowledge of analytical methods.
Ability to work independently with very little supervision, champion problem resolution, and recognize when to escalate to line management.

Nice To Haves

Previous QC experience.
Experience with process control systems.

Responsibilities

Execute and coordinate analytical testing of bulk drug substances and drug products in a multi-product facility.
Execute and coordinate raw-material sampling and testing and cleanroom sampling, as applicable.
Perform testing and review across several analytical technologies and independently execute three to five analytical methods with different scientific principles after adequate training.
Coordinate routine maintenance and manage or review fundamental laboratory tasks, including buffer preparation, TCU maintenance, and cleaning.
Perform routine quality and compliance activities, including authoring test methods, specifications, plans, reports, forms, and SOPs.
Review and trend analytical data and compliance processes to identify out-of-trend results, discrepancies, and process anomalies.
Ensure data discrepancies are investigated and assessed appropriately and that suitable root causes are established.
Identify and implement fundamental improvements to laboratory processes and compliance activities.
Provide compliant solutions for moderately complex methods and testing issues and champion problem resolution.
Coordinate work within the team and cross-functionally, and represent the team in matrix meetings to resolve issues and develop solutions.
Document work in accordance with cGMP and cGDP and follow site regulations and established procedures.
Report abnormalities and deviations accurately and promptly.
Adhere to safety standards, identify unsafe situations or habits, and escalate them appropriately.
Maintain and improve laboratory areas according to predefined 5S standards.
Maintain personal training compliance and train other associates and technicians on methods, operations, processes, and compliance topics after qualifying as a trainer.
Escalate issues to line management when appropriate.