Quality Technician (m/f/d)
- Performs inspection, sampling, testing, and release of raw materials by strictly adhering to SOPs, SWIs, material specifications, Federal Regulations, cGMP, training modules, sanofi pasteur policies and procedures, and safety guidelines. These activities are performed as dictated by PQ MR management to meet the demands of the production schedule.
- Maintains laboratory in a safe and compliant state. Manages inventory of raw material sampling utensils, sample containers, and safety supplies. Performs cleaning of laboratories sampling equipment.
- Processes and inspects product samples from contract manufacturers. Ensures cold chain of custody is kept on samples and samples are distributed to the applicable testing unit. Ensures cold chain of custody is maintained.
- Performs status tagging for raw materials within the Building 38 warehouse and associated off site warehouse locations. Performs status tagging for intermediates, final bulks, final containers, and finished product released by PQ Batch Release.
- Understand and support implementation of change controls, CAPAs, and deviation corrective actions. Notifies lab manager of any deviations or issues and initiates deviation investigations as required. Supports deviation investigations.
- Attends and contributes to scheduled team meetings, department meetings, and safety meetings. Performs document and procedure review as needed. Trains on departmental training modules as assigned. Pursues professional and or technical development training on/off site.
- BA/BS in life sciences prefered. A minimum of 1 - 3 years of relevant experience in a cGMP controlled/pharmaceutical industry.
- Excellent working knowledge of cGMPs (US, Canada, Japan, Europe). Experience in SAP, LabWare, EDMS, Trackwise, Aseptic Technique is beneficial.
- Fork lift certification preferred
Swiftwater, Pennsylvania [USA]