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Quality Assurance Specialist II
2 months ago
Position Overview:
The Quality Assurance Specialist II of the analytical team will be responsible for testing of in-process, lot release and stability samples for various commercial and clinical drug products. Author and revise Standard Operating Procedures (SOPs), deviations, Corrective and Preventive Actions (CAPAs), and Laboratory Investigation Reports (LIRs). Areas of responsibility include but are not limited to testing samples for Appearance, pH, UV and water content, High-Performance Liquid Chromatography (HPLC), Enzyme-Linked Immunosorbent Assay (ELISA), Western Blot, and Sodium Dodecyl Sulfate-Polyacrylamide Gel Electrophoresis (SDS-PAGE) as needed. Participate or lead investigations, reports, and process optimization activities as needed. Actively participate in group and project teamwork.
Job Duties:
Perform routine and non-routine release, in-process, and stability testing for drug substance, drug product, and other critical reagents and documentation under Current Good Manufacturing Practice (cGMP).
Perform Analytical assays such as HPLC (Size Exclusion Chromatography, Ion Exchange Chromatography, Hydrophobic Interaction Chromatography, Reversed-Phase Chromatography, affinity), ELISA, SDS-PAGE, Western Blot, Water Content, UV, Appearance, and pH.
Independently author and lead quality records such as Deviations, Lab Investigations, CAPAs, Change Control, including leading thorough and timely investigation and/or implementation activities.
Author and revise SOPs as needed.
Lead and/or support method development, optimization, transfer, qualification, and validation activities of analytical methods.
Support equipment and software qualification and maintenance activities.
Review of laboratory records generated in support of QC testing including procedures, methods, audit trails, and other controlled documents.
Provide training to laboratory analysts as needed and guide junior analysts in the lab environment including troubleshooting.
Work on multiple projects to meet departmental and organizational goals.
Work collaboratively with Manufacturing, Quality Assurance, and Regulatory to support Chemistry, Manufacturing, and Controls (CMC) analytical deliverables.
Requirements:
Bachelor's degree in a Science-related field.
3-4 years of experience in a Quality Control laboratory environment (GMP environment) with a commercial setting.
Hands-on experience with a wide range of analytical techniques such as ELISA, SDS-PAGE, Western Blot, Karl Fisher, and HPLC (SEC, IEX, HIC, RP, affinity).
Writing and/or authoring deviations, lab investigations, protocols, SOPs, reports, and data trending.
Desired:
Prior experience working in method validations, method transfers, Raw material, and stability testing is a plus.
Must be able to maintain data integrity, and understanding of US and international (e.g. EU, ICH, GXP) regulations.
Ability to manage multiple tasks and meet deadlines with a high tolerance for ambiguity, solutions-oriented, and able to problem-solve and identify root cause.
