The QC Analyst performs routine sampling, testing, and data reporting and performs support activities such as purchasing, receiving, and general laboratory maintenance as assigned by management. May coordinate with external suppliers of testing services.
Executes routine biochemical and chemistry release and stability testing following SOPs and records data in a GMP compliant manner
Performs peer review of routine test results.
Performs preventative maintenance and/or calibration activities, purchasing, receiving. Assumes responsibility for cleanliness and orderliness of work area and other laboratory maintenance duties as assigned.
Participates in QC continuous improvement initiatives; looks for ways to improve compliance or efficiency and communicates to management.
Participates in method validation of simple / complex analytical methods commensurate with experience and qualification of laboratory equipment as assigned
Participates in laboratory investigations and performs CAPA activities as assigned
Maintains required training and training records and provides training to qualify other Laboratory Associates.
Analyst requires Associates Degree for entry-level in chemistry, biology, pharmaceutical science or related degree, up to 2 years of applicable GMP laboratory experience for a Senior Analyst.
Excellent oral and written communication, organizational, and interpersonal skills with ability to multitask while working under restrictive timelines
Ability to work in a team environment and perform job responsibilities under minimal supervision.
Environment: Work is performed in a GMP lab setting with exposure to a variety of chemicals.
Physical: Exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force constantly to move objects.
Laboratory and/or Related Equipment (e.g., fume hoods, incubators, freezers, refrigerators)
Vision: See in the normal visual range with or without correction; vision sufficient to read computer screens and printed documents.
Hearing: Hear in the normal audio range with or without correction.