Quality Assurance Specialist

General Summary:  

Under the direction of the Quality Assurance Supervisor, this position will be responsible for all aspects of Finished Product release in accordance to 21CFR 211. This role is responsible for assuring quality according to product specifications and investigating any deviations and non-conformances. This position requires great organizational skills and attention to detail.  

Essential Functions/Responsibility:  

Follows Good Manufacturing Practices, Standard Operating Procedures and Job Safety Analysis in all areas of the job.  

Reviews Manufacturing and Packaging department specifications forwarded by R&D.  

Creates Packaging Line Specifications for production in a timely manner and maintains all supporting information in an organized manner.  

Creates and issues batch sheets (formulation sheets and manufacturing procedures) according to current SOP’s and Finished Product Specifications. 

Reviews and approves batch sheets, component reconciliation, product reconciliations, and production paperwork.  

Creates and reviews automated recipes for the Automated Recipe System.  

Reviews OTC Drug Finished Product paperwork for QA Release.  

Maintains Quality Assurance tracking spreadsheets and metrics. Investigates Quality Incidents.  

Assists in writing Quality Incident Investigation Reports and collecting any necessary data pertaining to the event, including consumer complaints.  

Tracks re-training associated with Quality Incident Investigations to make sure it is submitted in a timely manner.  

Conducts monthly Spot Audits for the Processing and Packaging Departments.  

Audits finished product as necessary and issues rework plans as needed.  

Maintains all plant documents and responsible for Document Control Program. Assist and Maintains Plant Internal and External Calibration Program.  

Executes PTR’s for new product releases and line trials.  

Participates in all job-related safety training and personally complies with all safety policies and procedures.  

Adheres to all safety procedures and wear appropriate PPE. 

Organizes and compiles all necessary paperwork to release finished product.  

Operates as a line of communication between line operators and suppliers of components to ensure product quality 

Knowledge, Skills and Abilities:  

Proficient in Microsoft Word, Excel, Outlook applications. Precise with a high level of attention to detail Possesses exceptional written and verbal communication skills. Exceptional math skills preferred. Knowledge of cGMP’s and 21 CFR 211 preferred Possesses a demeanor and attitude that builds positive relationships at all levels of the organization Actively participates and is highly efficient when working as a member of a team or as an individual contributor Ability to provide and sustain a strong level of customer service to the organization Ability to prioritize work assignments in a fast-paced work environment 

Education and Experience:  

Candidates must have a Bachelor’s degree in Math, Science or a related field. One to two years of QA experience in a fast-paced manufacturing environment with consumer goods or OTC drug industry experience will be a plus. 

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