QC Specialist-Large Molecule

1 month ago

Exton, United States Frontage Lab Full time

Quality Control Specialist-Large Molecule

Exton, PA (Corporate)

Frontage Laboratories

Frontage Laboratories is a CRO / Clinical Research Organization providing integrated, science-driven, product development services throughout the drug discovery and development process to enable life science companies to achieve their drug development goals. We have enabled many innovator, generic and consumer health companies of all sizes to file IND, NDA, ANDA, BLA, and 505(b)(2) submissions in global markets allowing for the successful development of important therapies and products for patients. We are committed to providing rigorous scientific expertise to ensure the highest quality and compliance. We have successfully assisted clients to advance hundreds of molecules through development to commercial launch in global markets. Come and join us to make a world of difference.

Responsibilities

* Review of Biologics bioanalytical data (notebook documentation, raw data, and LIMS data) for accuracy, consistency, and completeness to ensure compliance with SOPs and GLP.
* Review method development/qualification/validation reports and sample analysis reports including text and data for accuracy and consistency.
* Preparation of bioanalytical test result data tables for clinical testing reports. Review of client data transfer specifications. Prepare and transmit client data transfer tables. Other duties as assigned.

Requirements

* Bachelor's degree in chemistry, biochemistry, immunology, or another related scientific field.
* Quality control or quality review/audit experience within a biotech/CRO/pharmaceutical or laboratory environment
* Proficient in Microsoft Excel.
* Experience working in a regulated GMP/GLP environment
* Experience working with the Watson LIMS system is a plus
* Working knowledge in the use of ligand binding methods (ELISA, MSD, Gyros)
* Familiar with PK, ADA, and Biomarker data generated via ligand binding assays

Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.

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