Quality Control Analyst Jobs

About The Position

Requirements

• Bachelor’s degree in chemistry, Biochemistry, or a related field.
• Minimum of 3-5 years of experience (QC II) or 3-5 years’ experience (QC III) in HPLC, preferable in a bio-pharma analytical laboratory setting.
• Proficient knowledge of calibration and operation of HPLC system with Empower software.
• Hands-on experience in handling equipment like HPLC, PA800, Mass Spectrometry and others.
• Laboratory experience with a range of analytical techniques including, but not limited to, SEC, CE-SDS, DLS and similar methods is required.
• Knowledge of cGMPs and regulatory prerequisites concerning the biotechnology and pharmaceutical sectors.
• Familiarity with statistical methods applicable to the analysis of experimental data.
• Proficiency in general and non-routine laboratory skills.
• Exceptional interpersonal, communication, and organizational skills are a must.

Nice To Haves

• Experience in quality control is desired to required based on the level.
• A solid foundation in molecular biology is desired.
• Experience with viral vector (adeno-associated virus) products is a plus.
• Proficiency in MS Office and equipment-related software like Soft Max Pro is desired.

Responsibilities

• Conduct release testing in alignment with nonclinical and clinical viral vector products, adhering to GxP guidelines.
• Generating, analyzing, and interpreting analytical testing data for Drug Substance and finished products, ensuring the accuracy and reliability of the results.
• Providing technical expertise as a subject matter expert in the implementation, execution, and troubleshooting of analytical methods within the testing laboratory, specifically focusing on SEC.
• Develop, understand, follow, optimize, modify, and/or assist in the development of standard operating procedures (SOPs); partake in writing, reviewing, and revising SOPs.
• Carry out release, stability, and in-process testing of materials, samples, and final products.
• Execute analysis and interpretation of test outcomes, pinpoint deviations, and propose suitable recommendations.
• Engage in method and equipment qualification/validation studies; generate protocols, carry out and coordinate experiments, and draft reports.
• Assist in assay development, nonclinical sample testing to support IND-path studies, and lead QC projects and investigations when necessary.
• Offer guidance to junior staff, apply technical knowledge daily, and may liaise with contract testing labs.

Benefits

• Inclusion and Diversity are at our core.
• We believe in the power of being your authentic self.
• We strive to create the space which allows for everyone in our Adverum Community to not only feel safe but encouraged to speak, learn from each other, grow in their professions and be the very best versions of themselves no matter what their age, ethnic background, gender, origin, religion or sexual orientation.