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Description

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 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

• 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

• 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

• 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

• Provide training and coaching to Quality and Operations, on topics such as SOP, GMP and root cause analysis

• Perform other responsibilities, as assigned.

Qualifications

• You have at least a Bachelor's degree or equivalent through experience

• You have a sense of initiative and can work independently as well as in a team

• SAP knowledge is a plus

• Knowledge of GDP is a plus

• You are someone with an eye for detail who values quality

• You have strong verbal and written communication skills

Equal Opportunity Employer

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].