Primary role of the QC technician/analyst position is receiving, inspection and sampling of incoming raw materials as assigned by management. In addition, the technician/analyst also supports routine sampling and testing of utility samples and raw materials.
Performs routine inspection, sampling, labeling and documentation of incoming raw material, in addition to inspection of retain samples. The technician will also be responsible for shipment of material offsite for testing purposes; in addition to inspection and labeling of incoming GMP supplies.
Manages raw material retains, supports inventory management, collects utility samples using established procedures as part of environmental monitoring.
Executes routine wet chemistry testing following SOPs and records data in a GMP compliant manner
Participates in QC continuous improvement initiatives; looks for ways to improve compliance or efficiency and communicates to management.
Maintains required training and training records.
Technician requires a high school diploma with 0-2 years’ experience. Analyst requires Associates Degree in chemistry, biology, or related discipline, with up to 2 years’ experience. Prior experience of incoming raw material testing in pharmaceutical/biotechnology setting is a plus. Experience with aseptic techniques is a plus.
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 50 pounds of force occasionally, and/or up to 20 pounds of force constantly to move objects, including ability lifting objects up to 40 pounds.
Handheld identity testing devices: Raman, FT-IR
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.