What are the responsibilities and job description for the QC Specialist-Large Molecule position at Frontage Laboratories?
Quality Control Specialist-Large Molecule
Location: Exton, PA
Full-time
Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.
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
Salary and Benefits:
Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance.
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.
