Quality Operations Specialist in Markham
Our client, a leading Cosmetics manufacturing company is looking for a Packaging Analyst Specialist for quality operations to join their growing team.
Working location: Markham, ON
Shift: Afternoon shift
Quality Operations Specialist is responsible for quality assurance activities related, but not limited to, incoming raw materials & components, manufacturing floor operations (compounding, filling, utilities and warehouse), and suppliers. Quality assurance activities include leading deviation handling, root cause analysis and CAPA development, conducting document reviews to verify the effectiveness of procedures and instructions, and providing training and coaching to Quality and Operations on SOP, GMP and root cause analysis.
This position is responsible for supporting the quality function in the assigned manufacturing or assembly plant. It is responsible for providing the tools and analysis necessary to ensure the quality of the process. It is the responsibility of this position to confirm and maintain change to component standards. This position assures compliance with regulatory requirements and focuses on consumer expectations.
KEY RESPONSIBILITIES:
Issues Resolution/Continuous Improvement (60%)
- Escalate critical issues to Quality/Operations leadership as required
- Investigate critical customer and consumer complaints
- Disposition out-of-spec materials, as directed
- Monitor progress against improvement initiatives identified by Quality Engineers, CI and ME
- Maintain ongoing communication with Production, QA Labs, Assembly, Packaging, SRP, Distribution and component suppliers regarding quality issues
Document Review & Auditing (30%)
- Conduct documentation reviews in the plant (production, importation and compounding as applicable) for compliance with existing procedures and instructions, and verify the effectiveness of procedures and instructions versus EL requirements and needs
- Determine disposition of product based on findings and audits and evaluate product issues on the production floor – coordinating the resolution.
- Initiate, revise and review controlled documentation including procedures,
investigations, deviations, and reports. - Participate in routine GMP audits in the plant
- Maintain records and ensure that the proper data is entered into the corporate computer system as well as create, revise and maintain documentation
- Perform independent project work related to corporate or departmental goals and objectives and participate in system improvement programs
Training/Coaching (10%)
- Provide training and coaching to Quality and Operations, on topics such as SOP, GMP and root cause analysis
- Perform other responsibilities, as assigned.
Qualifications:
- Education: 4-year degree or equivalent experience
- Experience: Minimum 3 years of work-related experience
- Experience in Fast-Paced Consumer Goods manufacturing environment a plus (Cosmetic, Food, or Pharma)
- Ability to interpret and assess operational compliance against Good Manufacturing
- Practice Regulations (FDA, KFDA, HC, ISO22716)
- Ability to execute and coach teams in root cause problem solving and associated
- Corrective and Preventive Actions (CAPA)
- Ability to identify and drive process improvement opportunities by partnering with cross-functional stakeholders
- Effective oral and written communication skills and ability to appropriately communicate information to cross functional stakeholders and suppliers
- Knowledge and ability to execute statistical sampling, AQL/ANSI interpretation, and read/interpret specifications, drawings
- Ability to utilize standard tools and equipment (such as scale, fill weight, cap torque, viscometer, pH meter, pull force, seal burst, and other relevant equipment)
- Ability to review SOP’s, GMP reports
- Proficiency in Microsoft Office Suite, Electronic QMS, and SAP systems is preferred
How to Apply:
Please click APPLY with your resume and send your resume to resume2021@gc-employment.com with the subject " Quality Operations Specialist".
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We are an equal opportunity employer. All applicants will receive consideration for employment, without regard to race, colour, religion, creed, national origin, gender or gender-identity, age, marital status, sexual orientation, veteran status, disability, pregnancy or parental status, or any other basis prohibited by law.
We are dedicated to building a workforce that reflects the diversity of our customers and communities in which we live and serve. We are committed to providing reasonable accommodations to applicants with physical and/or mental disabilities. If you require accommodation throughout the hiring process, please let us know and we will work with you to meet your needs. Reasonable accommodation requests are considered on a case-by-case basis.
