Kelly Services Quality Assurance Associate in Markham, Canada

Kelly Services has an opening for a Quality Assurance Associate for our customer in Markham, Ontario. This assignment is budgeted through the end of February 2019. The QA Associate ensures GMP and GDP compliance for the distribution operations. This also includes participating in internal audits, assisting in maintenance of audit records and documenting follow-up from audits.

Key responsibilities:

• Ensure documentation management systems are current and meet all GMP/corporate/technical requirements

• Supports Quality Management reviews

• Works with inter-disciplinary teams across organizations to investigate, resolve and prevent

quality issues

• Overall monitoring of pest control, facility maintenance/validation and equipment calibration and resolution of any issues

• Ensures investigations and documentation of quality issues so that they are addressed and

resolved in a timely manner

• Writes and revises SOPs and change controls

• Assists in conducting Gap Assessments of current SDC SOPs against customer standards

• Oversees the execution of holds and recalls

• Assist in writing and monitoring CAPAs

• Liaise between Franchise and SDC for quality and compliance issues (i.e, quality

holds/returns/repack and relabel/SAP investigations).

Qualifications:

• B.S. Engineering, or other related degree Required; post graduate diploma in Quality and Reg Affairs an asset

• 2+ years’ experience working in a regulated environment

• Experience in a distribution or manufacturing setting

• Device or pharma experience an asset

• Experience in Quality Systems, Corrective and Preventive Action/ Non-conformance systems, Good

• Manufacturing Practices/ Good Distribution Practices an asset. Process Excellence / Lean / TQM

experience an asset

• Attention to detail

• Sense of urgency, results and performance driven – works independently with minimum supervision

• Collaboration and teaming including cross-functional teams, negotiates and resolves conflicts effectively

• Ability to influence multiple stakeholders

• Exemplary communication skills

• Strong sense of integrity

• Good understanding of operations processes

• Strong knowledge of GMP’s and GDP’s

• Strong technical writing skills

• Ability to apply risk management philosophy to business processes, decisions and data

If you meet the above qualifications, please apply!