Job Description

Job Title:  Quality Associate

Pay:  $25.00 - $27.00/hour
Benefits:  Eligible to Enroll in Medical Benefits

Job Description:  Job Description:  Provide direct support to Quality personnel regarding operation of the department and Quality System. This position supports a wide array of activities related to: NCR/CAPA and Training

• Execute Investigations, Root Cause Analysis, Correction, Corrective and Preventive Action activities in accordance with the Quality System Corrective/Preventive actions and product non-conformance control including: capturing data and investigations associated with product deviations, product non-conformances, CAPAs, scrap and rework, and analyzing the data for the reasons of Quality Improvement and reporting.
• Ensure the operation of Manufacturing and Quality activities in relation to compliance to Quality Standards and Regulations.
• NCRs and CAPAs including: capturing data and investigations associated with product deviations, product nonconformance's, CAPAs, scrap, and rework, and analyzing the data for the reasons of Quality Improvement and reporting.
• Support Change Control activities - Originate and review internal operating procedures and specifications through the Document Change process.
• Adherence to regulations - Assist with adherence to all Federal, State, and Local Regulations controlling the manufacture of medical devices.
• Support the operation of Manufacturing and Quality activities in relation to compliance to Quality Standards.
• Originate, review, and approve internal operating procedures and specifications through the Document Change process

Requirements:

• BS/BA in Physical Science or Engineering, preferably Biomedical.
• College graduates with no industry experience encouraged to apply.
• Experience in Quality Assurance and/or other regulated industry or similar experience a plus.
• Strong technical writing skills and general problem solving skills.
• Manage multiple priorities and work with interruptions.
• GLP and/or GMP experience a plus. 
• Medical Device knowledge a plus.
• Requires Vision Assessment (20/20 near visual acuity & acceptable color vision).

Pinpoint Pharma is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.