Quality Operations Specialist- CSAR

Quality Operations Specialist- CSAR is responsible for Quality Assurance activities in accordance with CSAR (Cosmetic Supervision & Administration Regulation) requirements in manufacturing operations (compounding, fill & assembly, incoming raw materials & components, utilities, and warehouse). Quality Assurance activities include leading deviation, quality inquiry, and consumer complaint investigations, root cause analysis, and CAPA development, performing internal audits, conducting document reviews to verify effectiveness of procedures and instructions and providing training and coaching to Quality and Operations on SOP, GMP and root cause analysis. This position will provide a broad range of quality oversight for manufacturing operations. Issues Resolution/Continuous Improvement (60%) Drive deviation, consumer complaint, and quality inquiry investigations, determine root cause, and develop CAPAs Collaborate with Quality, Operations, and Suppliers to address product quality issues Confirm CAPA completion and effectiveness Perform internal audits to assess GMP compliance Identify trends and escalate critical issues to Quality/Operations leadership as required Disposition materials and product as directed Monitor progress against improvement initiatives identified by Quality Engineers, CI and CVE Document Review & Auditing (30%) Conduct manufacturing record (compounding batch records, fill and assembly records, etc.) reviews for compliance to CSAR, existing procedures, and work instructions, and disposition product accordingly. Initiate, revise, and review controlled documents to ensure the effectiveness of procedures and ensure instructions meet EL requirements and needs Lead routine GMP, internal, and process audits in the plant 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 Experience in fast-paced consumer goods manufacturing environment, preferably in a regulated industry (cosmetic, food, pharmaceutical or medical device) Ability to interpret and assess operational compliance against Good Manufacturing Practice Regulations (CSAR, FDA, MFDS, Health Canada, ISO 22716) Ability to review and analyze batch records for GMP/GDP compliance and adherence to defined processes Ability to execute and coach teams in root cause problem solving and associated Corrective and Preventive Actions (CAPA) Experience with root cause analysis, risk assessment, and trend analysis Ability to identify and drive process improvement opportunities by partnering with cross functional stakeholders Ability to execute, summarize and manage process audits in the manufacturing areas 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, engineering drawings, and compounding/assembly instructions Ability to utilize standard tools and equipment (such as scale, torque meter, viscometer, pH meter, Chatillon gauge, seal burst, and other relevant equipment) Ability to draft and review SOP’s, batch records and investigation reports Proficiency in Microsoft Office Suite, Electronic QMS, and SAP systems is preferred Job: Quality Assurance - Supply Chain Primary Location: US-NY-Melville Job Type: Standard Schedule: Full-time Shift: 1st (Day) Shift Job Number: 2221195 We are an equal opportunity employer. Minorities, women, veterans, and individuals with disabilities are encouraged to apply. It is Company's policy not to discriminate against any employee or applicant for employment on the basis of race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, protected medical condition as defined by applicable state or local law, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances. The Company will endeavor to provide a reasonable accommodation consistent with the law to otherwise qualified employees and prospective employees with a disability and to employees and prospective employees with needs related to their religious observance or practices. Should you wish to apply for this position or any other position with the Company and you believe you require assistance to complete an application or participate in an interview, please contact [email protected].