The Quality Assurance Specialist is essential to the warehouse operation and ensures the success of safety and compliance within the branch.
This is a good opportunity for someone with great attention to detail. Your Role The Quality Assurance Specialist I will assume responsibility for the ongoing support and maintenance of the Quality Management System at the local level within the assigned business unit(s).
This role will execute branch Quality functions employing knowledge including but not limited to : cGMP's, corporate policies and guidelines, company work instructions, client SOP's, and all the applicable Health Canada regulations associated with the functions performed at the assigned business unit(s) (e.
g. narcotic control, controlled drugs and substances, precursors, etc.). The RPIC / ARPIC will assume full responsibility for all transactions involving precursors.
The QPIC / AQPIC will assume responsibility for all transactions involving controlled and targeted substances. Your Responsibilities
Support local Management within the Corporate QSHE organization while maintaining location compliance to all Federal, Provincial and Local Quality requirements, where applicable;
Assist to the flow of Operations including Inbound, Returns, Destruction, Outbound, Retention etc. where Quality support may be required;
Release and / or quarantine product in accordance to client instructions and regulatory requirements;
Inspect finished products and oversee the sampling of these products for testing and retention purposes;
Review and sign off on QA records such as certificates of destruction, calibration records, sanitation, pest control, training, etc.;
Monitor temperature conditions of the facilities as well as review inbound product temperature conditions;
Maintain the site training program and applicable documentation;
Facilitate Preventative Maintenance with the qualified vendor(s) on equipment within the responsible site that may impact quality and integrity of health care products;
Support development and implementation of change controls, WI’s, and SOP’s using an advance knowledge of GMP’s and industry standards;
Maintain site documentation control and records retention for all local forms, working instructions, profiles, customer SOP's, and client specific documentation;
Review and reporting of non conformance and planned deviation reports to ensure they are addressed at site level, including root causes completeness and timely implementation of CAPAs;
Supervise the daily operational transactions of CDS / PCR products and fulfill regulatory reporting obligations per OCS (Office of Controlled Substances) regulations;
Support internal facility audits and external audits on behalf of KN;
Other duties as may be assigned Your Skills and Experiences Professional Experiene Required
1-3 years industry experience in Medical Device / Pharmaceutical industry in QA. RA experienced may be considered
2+ years industry experience in Medical Device / Pharmaceutical distribution is preferred
Meet Health Canada's requirements to perform RPIC and QPIC responsibilitiesKnowledge Required
Knowledge of Quality Management systems and standards (i.e : GMP, ISO 13485, ISO 9001)
Knowledge of warehouse inventory management systems
Strong knowledge and understanding of GMP's, GDP's, licensing, Federal and Provincial reg Education Required
Bachelor in Sciences (e.g. Pharmacy, Chemistry, Biology, Engineering or a related discipline) is required
Diploma / Degree / Certificate in Quality Assurance is preferred