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Associate Manager, Quality
2 weeks ago
Joining the team at SC Johnson Professional® makes you part of a family company with a deep history in the professional market as a leading manufacturer of skin care, cleaning and hygiene products and smart technologies. We’re a team of more than 1,000 employees across five continents providing solutions to healthcare, industrial and institutional markets across the world. - SC Johnson Professional® is a business unit within SC Johnson, a family-owned and led company and leading manufacturer of quality, trusted products since 1886. : The purpose of this position is to oversee day-to-day quality assurance, compliance and validation activities in compliance with Health Canada GMP & FDA cGMP regulations. SKILLS, KNOWLEDGE AND EXPERIENCE REQUIRED: - Minimum of seven (7) years work experience in quality assurance, quality control and validation in a pharmaceutical manufacturing industry, cGMP environment required. - Strong knowledge of pharmaceutical validation requirements, including process, cleaning and computer systems validation. - Relevant quality certification via a recognized body such as American Society for Quality is an asset - Thorough knowledge of applicable regulatory standards as it relates to GMP / cGMP and GLP. - Proficient knowledge of electronic systems including MS Office and Smartsheet - The ability to multitask and manage time effectively to ensure all work streams are managed - Emotional resilience and an ability to work under pressure with a "can do attitude" - Ability to process a high volume of planned and un-planned work effectively - A determination to continually develop and improve existing processes - Strong interpersonal skills required to effectively liaise with manufacturing staff, administration staff and external contacts. - Good verbal and written communication skills in dealing/corresponding with outside contacts and internal staff. - Good judgement and problem-solving skills necessary when dealing with results that require modifications/resolving. MAIN DUTIES AND RESPONSIBILITIES: - Development and implementation of department procedures and test methods. - Planning, scheduling, delegation work assignments and assessing the performance of department staff. - Prepare annual budget for department as well as propose department operation efficiency improvement plan. - Manage compliance programs (Change Control, Deviation, CAPA, Internal audit etc.) of all company operations as required. - Final release of finished products by ensuring all test results and executed documentations are complete and according to GMP. - Ensuring compliance with legislated and regulatory protocols. Facilitate regulatory audits, prepare Audit response; Conduct supplier audit if necessary and prepare audit report. - Oversee product recall, product return authorization and ensure the implementation of quality system under GMP. - Facilitate discussions with 3rd party customer on product specification and quality standard. - Manage and administer the Customer Complaints Policy and Procedures. - Approving analytical methods, SOPs and other controlled documents under GMP. - Ensures calibration and maintenance program of the quality department is current and effective. - Ensures Standard Operating Procedures relating to Quality Control and Quality Assurance are current and up to date. - Follows established Standard Operating Procedures as well as company policies and procedures. - Communicates regularly with production and other departments to effectively plan activities. - Provide monthly and annual product quality review and propose quality improvement plan to senior management. - Responsible to ensure self and employees directly reporting to, follow and adhere to all company work procedures, GMP’s, occupational health and safety practices, personnel policies, and complete all documentation (as required). - Supervises and trains quality control and quality assurance staff. Handles any department employee complaints, absentee problems, or other personnel issues in accordance with company guidelines in coordination with HR. - Must become familiar with the rules and safety programs applicable, follow prescribed health and safety procedures and participate in the process of identifying, reporting and assisting in eliminating risks to health and safety in the workplace. - Collaborate with Director, NA Quality and other site quality leads in SCJ to drive regional and global quality initiatives - Perform other tasks assigned by Director, NA Quality RESULTS OF ERRORS/ KEY PERFORMANCE INDICATORS: - The company could be in violation of legislated laws and regulatory protocols. - Product recalls, regulatory action and customer complaints could result in profit loss. - Product loss due to time allotted to re-work products. - The company and/or Employee could be in breach of confidentiality HOURS OF WORK: - 8 hours per day / 40 hours per week. Normal hours of work are 8:30 a.m. to 5:00 p.m. with a 1 hou
