The Quality Systems Coordinator is responsible for training or coordinating the training of laboratory, manufacturing, and facilities employees, authoring of laboratory testing protocols, raw material and product specifications, frequent periodic monitoring of Quality Control (QC) and Analytical Development (AD) chambers and warehouse refrigerators/freezers, ensuring that QC, AD, warehouse chambers, refrigerators, and freezers and monitoring equipment are maintained, repaired, as needed and that documentation required by QA is acquired and submitted in the timelines specified in SOPs. The Coordinator is also responsible for ensuring that all AD and QC equipment is calibrated and validated as appropriate within the required timelines. He/she is responsible for ensuring that the stability schedule is updated and maintained as well as authoring R&D and GMP stability protocols. The Coordinator will hold the responsibility of ordering materials, supplies, and equipment for the AD and QC laboratories.
Essential Job Functions:
• The Quality Systems Coordinator (QSC) is responsible for ensuring that all new and existing laboratory, manufacturing, and facilities employees initiate and complete their required training as new employees and for on-going training on new and revised SOPs as well as SOP refresher training. The QSC will work with Quality Assurance to confirm that all required training records have been submitted to QA and that the training database is frequently update and maintained.
• He/she is charged with authoring of GMP and non-GMP stability protocols and raw material and product specification documents and circulating for review and approval. The QSC will track the review and approval of these documents and ensure they are approved in the agreed upon timeline.
• The QSC will follow approved SOPs for frequent monitoring of stability chambers, completion of required forms and submission of documentation to QA. He/she is solely responsible for ensuring that investigations are performed and completed to identify potential impact of out of specification conditions on the products contained in the chambers.
• The QSC is responsible for ensuring that AD and QC stability chambers and GMP instrumentation are maintained, repairs, calibrated and validated as appropriate before their due dates. He/she will work with external contractors and internal resources to obtain quotes, coordinate activities, and collect calibration certs, validation reports, and records of repairs. The QSC will review all associated records for accuracy and completeness prior to submitting to QA.
• He/she will coordinate the ordering of materials, supplies, and equipment for the AD and QC departments, obtaining quotes, generating POs, tracking shipments and restocking the laboratories.
• He/she will author R&D and GMP stability protocols and circulate for review and approval in the required timeline. The QSC is also responsible for updating and maintaining the stability schedule database.
• The QSC will perform GMP peer review of data from the AD and QC groups.
Education: B.S in a scientific discipline preferably in pharmaceutics, chemistry or other related fields
Experience: A minimum of 4 years of pharmaceutical industry experience, with highly proficient capabilities in project management, team leadership and written communication skills.