QA Specialist



Job Description:The role of the Quality Assurance Specialist is to support the Quality Assurance Senior Consultants in fulfilling their roles to the clients by working closely and communicating regularly with the Senior Consultants with respect to the required work to be done. Quality Assurance Senior consultants at IQR Consulting Ltd. are responsible for providing quality and regulatory support to clients in the natural health product, food, cosmetic, pharmaceutical, medical device and cannabis industries. This position will report to the Primary Consultant / President but will support the other Senior Consultants through the direction of the Primary Consultant / President. The Quality Assurance Specialist role requires strong verbal and written communication skills, proactive attitude, strong organization skills, excellent time management, problem-solving, strategic thinking, teamwork, flexibility and an eager to learn attitude. This position includes helping the Senior Consultants in establishing and maintaining aspects of clients’ quality systems as required including but not limited to the following: · Support identification, investigating and logging to completion: o Complaints o Adverse Reaction reports o Non-conformances o Deviations o OOS o CAPAs · Preparing and Completing the following: o Risk analysis o Change controls o Recalls (assisting the Senior Consultant where required) o Mock recalls o Quality Trending Reports o Annual Summary Reports (for Adverse Reactions) · Initial reviewer of finished products requiring release · Setting up and maintaining material and product specifications · Setting up and maintaining label masters · Perform label reviews (Canadian NHPs, US Dietary Supplements) · Assisting in maintenance of retained samples for clients that require this activity · Review and maintain temperature monitoring reports for clients that require this activity · Communicate with third party laboratories in obtaining quotes for client testing; preparing test requisition forms and arranging for obtaining samples and sending out to the third-party laboratories (for regular testing and stability testing) · Assisting Senior Consultants with setting up stability studies and subsequently keeping track of testing time points, reviewing results and following up on any required investigation, updating the stability summary reports and preparing the final stability report · Assisting Senior Consultants with establishing and reviewing quality agreements · Assisting Senior Consultants with conducting audits and participating in regulatory authority audits for clients · Assisting Senior Consultants with providing training to clients and their employees, as required · Maintaining client quality and regulatory files as required, both electronically and physicallyManage product holds, reprocessing actions and assess product quality risk as needed in determination of final product dispositionMaintain initial and ongoing training on required SOPs and GMPs Qualifications:Bachelor’s Degree in ScienceDirect work experience with QA systems (at least 2 years)Knowledge of Health Canada GMP regulations for Natural Health Products, foods and Pharmaceutical ProductsExcellent computer skills including proficiency with MS Excel, Word and OutlookChemistry and microbiology knowledge an assetAbility to work and make decisions in a dynamic and fast-paced environmentAbility to present information and communicate with clients and colleagues in a clear wayDetail-oriented with proven analytical and problem-solving skillsHighly developed organizational and time management skills with the ability to prioritize and manage a diverse number of projects Job ID: 48421863
IQR Consulting

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