QA Associate - Floor & Product Release - Day Shift

We’re Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it’s innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we’re dedicated to addressing patients’ needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together.

Quality Assurance Associate – On the Floor and Product Release

12 month contract

Stouffville, Ontario

Day shift :
Tuesday to Saturday 6:00am-2:30pm

• Audit of executed manufacturing/packaging/testing batch records and release of bulk/finished goods in as close to real time as possible ensuring GMP and SOP compliance including electronic data review.
• Complete QA final identification sample, prepare accurate, clear and logical audit notices and maintain audit metrics.
• Provide quality oversight and support in the evaluation of quality floor incidents, which includes completing the Deviation Investigation Form (DIF), review and approval of Work Orders, review and approval of PSS comments, review of change controls, electronic data review and performing trend analysis for walkthroughs and work orders.
• Lead and work collaboratively with site operations in the resolution of quality incidents and deviations by completing the DIF and determining product impact, root cause and applicable CAPAs to ensure compliance with GMPs and SOPs.
• Perform additional documentation audits/reviews and internal plant GMP audits such as logbook auditing, periodic trend analysis, BAS acknowledgement comments, Work Orders and evaluations.
• Perform sampling of water and environmental monitoring, annual sampling schedule preparation daily walkthroughs, review of log books, daily spot checks on the BAS, reviewing BAS acknowledgements and evaluating BAS incidents and periodic trend reports.
• Perform AQL evaluations including issuance, verification and evaluation and assist in the sampling and tagging of packaging material, bulk or finished products when required.
• Work collaboratively with site operations and QA in the resolution of GDP/GMP deviations to ensure compliance with GMP and SOPs.
• Respond to quality incidents as required.
• Support retention sample area if applicable.
• Liaise with Planning, Operations, Validation, Technical Operations, QC, Regulatory Affairs, Compliance and other QA teams to obtain necessary information/documentation required for product review/release to meet MPS schedule.
• Support in minor deviations, complaints, CAPA’s, CAPA ERs as and when required.
• Prepare a daily quality shift report and communicate with internal and external stakeholders on any queries related to batch release documentation.
• Other duties as assigned.

• Hold a Canadian university degree or a degree recognized as equivalent by a Canadian university or Canadian accreditation body in a science related to the work being carried out.
• One (1) year of relevant Quality Assurance experience. Preferred:
  Three (3) years of relevant Quality Assurance experience.
• Must be computer literate with good working knowledge of Track Wise, Oracle and/or SAP ERP systems, LIMS and MS Office suite (Excel and Word).
• Good working knowledge of SOPs, GMPs applicable to Quality Operations, Quality Control, Manufacturing and Packaging. Understanding of Good Documentation Practices (including Data Integrity).
• This position requires a mechanical aptitude to understand manufacturing, packaging and quality control testing operations as well as the mechanical aspects of the plant.
• Abili…