QC Lab Senior Supervisor

OVERVIEW

The Quality Control (QC) Lab Senior Supervisor is responsible for overseeing and ensuring the completion of day-to-day tasks within the QC Laboratory. Including administrative duties that fulfill day-to-day operations in the QC laboratory. Additional duties may also include investigative research related to customer care issues, customer related inquires, internal issues regarding testing (including bacterial, yeast, and fungal strains, instrument troubleshooting), and product development. This position reports to the Quality Control Lab Manager.

DUTIES AND RESPONSIBILITIES

• Oversees day-to-day operations within the QC Laboratory.
• Advises staff, conducts lab investigations related to non-conformances (NCs) or customer care issues, troubleshoots, notifies Quality Control Lab Manager or designee, and assists with related reporting.
• Reviews and signs off assay data sheets in a timely manner.
• Stays up to date on all tasks assigned.
• Performs in-depth testing for investigative purposes resulting from both internal and external concerns (product development and customer cares) including written reports.
• Aids in laboratory troubleshooting for cultures, instrumentation, and reagents.
• Stays up to date with current literature regarding any related method that can be utilized within the QC laboratory.
• Completes tasks independently and in a timely manner, with weekly check ins with supervisor and use of project management tools.
• Performs endotoxin (KQCL), pH, conductivity, osmolality, PCR, protein/nucleic acid gel electrophoresis, RNase, DNase, Protease analysis and other assays as needed.
• Ensures testing requirements and deadlines are met; Reviews and interprets QC test results.
• Generates, reviews, and/or maintains records, certificates of analysis, or documents in a detailed and consistent manner.
• Coordinates and manages continuous improvement projects.
• Revises standard operating procedures and other relating documents, which are submitted to management for review and final approval.
• Maintains specific QC files and database records for process and/or quality improvement efforts.

EDUCATION

• Bachelors degree in Chemistry, Biochemistry, Microbiology or related scientific field; supplemented by 2-3 years applicable laboratory experience

KNOWLEDGE / SKILLS / EXPERIENCE

• 4-7 years’ experience in a manufacturing or quality control setting including at least 1 year prior supervisory experience
• Aseptic technique; DNA and plasma purification experience a plus
• Fundamental and working knowledge of computers, including MS Office applications (i.e. MS Word, MS Excel, etc.)
• Good human relations and oral/written communication skills
• Ability to organize and handle multiple projects concurrently
• Strong math skills
• Must be able to walk, bend, carry, lift, push and pull at least 40 pounds

DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Must be able to walk, bend, carry, lift, push and pull at least 40 pounds

EEOC