This position performs quality inspections on incoming material, which includes verification of supplier documentation, statistical sample removal, visual inspection, dimension testing, and status tagging of materials by strictly adhering to Sanofi Pasteur policies and procedures and cGMP. The position is required to perform cleaning of work areas, equipment, and any other jobs, as required.
· The position requires that the incumbent interact with external customers as a representative of Sanofi Pasteur Quality Operations. External companies include raw material vendors and other Sanofi sites on a global level.
· The incumbent must process raw material batches to ensure timely disposition within agreed upon timelines to support production scheduling and or marketing expectations.
· The incumbent must work within the policies, procedures, and regulations as required by the Company and under the Occupational Health and Safety Act.
· Attention to detail in recording GMP data right first time into GXP documents.
· The ability to handle multiple priorities (and respect timelines) is required in order to surpass milestones.
· The ability to negotiate, work with and influence a variety of people in a positive manner while identifying, and working to solve problems is a requirement of the position.
· The incumbent must be able to work effectively with colleagues at other sanofi, contract sites, and outside vendors to ensure that GMP data is available in a timely manner.
Each individual working in a GMP area is responsible for following the documented processes and recording GMP data correctly. Non-compliance in following a GMP process or procedure may result in regulatory observations, up to and including recall, and a significant risk to the site's continued operation.
· 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.
Education & Experience:
· BA/BS in life sciences prefered. A minimum of 1 - 3 years of relevant experience in a cGMP controlled/pharmaceutical industry.
· Excellent organizational, written, interpersonal, leadership and teamwork abilities. Excellent working knowledge of cGMPs (US, Canada, Japan, Europe). Experience in SAP, LabWare, EDMS, Trackwise, Aseptic Technique is beneficial.
· Fork lift certification preferred
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.