QA Associate – Day shift
City : See posting
Category : See posting
Industry : Pharmaceutical/Healthcare
Employer : Teva Canada
Who are we?
The Quality Assurance Associate will provide support to operations by leading the evaluation of quality floor incidents which includes completing the Deviation Investigation Form (DIF). Performing the release of bulk and/ or finished product. Reviewing and approving Work Orders and performing trend analysis for walkthroughs and work orders. Supporting the audit of batch records and log books and performing daily spot checks on the BAS, reviewing BAS acknowledgements and evaluating BAS incidents.
Tasks will include but are not limited to:
- Perform timely reviews of work orders ensuring appropriate steps/actions have been taken and documented. Daily QA/Operations walkthrough/audit (including routine spot checks of BAS and evaluate alarms) and periodically perform trend analysis for walkthroughs, and work orders.
- Lead and work collaboratively with site operations in the resolution of quality incidents and minor deviations by completing the initial investigation form as well as formal deviation report.
- Determine product scope and impact, root cause and applicable CAPAs to ensure compliance with GMPs and SOPs.
- Support bulk release backlog management by performing bulk batch record auditing and release functions per business requirements.
- Perform additional documentation audits/reviews and internal plant GMP audits such as Acceptance Quality Limit (AQL) inspections, BAS acknowledgement comments, Work Orders and evaluations.
- Prepare a daily quality shift report.
- Hazard Recognition and Investigation Skills: Identify, prevent, and proactively correct workplace hazards and conditions. Perform incident/accident investigations, root cause analysis, and establish appropriate corrective actions.
- Other duties as assigned.
- 1+ year relevant experience in Quality Control, Quality Assurance or Operations, a proven track record within the pharmaceutical industry, or equivalent higher education. Preferred: 3+ years relevant experience in Quality Control, Quality Assurance or Operations or a proven track record within pharmaceuticals
- University Degree in Science or related discipline from a recognized Canadian University (or non- Canadian institution evaluated as Canadian equivalent)
- Strong computer skills with good working knowledge of TrackWise, Oracle, LIMS, Smart QA, MS Office suite (Excel and Word)
- Good working knowledge of SOPs, GMPs, and cGMP’s applicable to Quality Operations, Manufacturing and Packaging
- This position requires a mechanical aptitude to understand manufacturing and packaging operations as well as the mechanical aspects of the plant
Already Working @TEVA?
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