Quality Operations Specialist- CSAR

Quality Operations Specialist- CSAR is responsible for Quality Assurance activities related to CSAR regulation adherence in Compounding and/or Fill & Assembly, 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 effectiveness of procedures and instructions, and providing training and coaching to Quality and Operations on SOP, GMP and root cause analysis. Issues Resolution/Continuous Improvement (60%) Identify and review deviations, determine root cause, and develop CAPAs in collaboration with Quality, Operations staff and suppliers to address product quality issues and GMP related activities Certify CAPA completion and effectiveness 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 Document Review & Auditing (30%) Support CSAR 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 Perform final (for importation yearly) review of executed batch and filling records and disposition product Initiate, revise and review controlled documentation including procedures, investigations, deviations, and reports. Participate in routine GMP 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 a plus (Cosmetic, Food, or Pharma) Ability to interpret and assess operational compliance against Good Manufacturing Practice Regulations (CSAR, FDA, KFDA, HC, ISO22716) Ability to analyze batch records for GMP/GDP/CSAR Compliance and adherence to defined processes 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 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, drawings and compounding/assembly instructions 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, batch records and investigations 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: 2221196 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].