Intern, Quality Assurance

About the position

Intern, Quality Assurance is responsible for actively participating in 'on the floor' Quality activities during product manufacturing and/or packaging, under close supervision, reviews all pertinent records, including Batch Production Records and laboratory Certificates of Analysis to confirm accuracy and, with guidance, makes the determination of acceptability for product release. Quality activities include product sampling and inspection, area clearance to confirm process readiness, and non-conforming event support to resolve in-process issues. Communicates to multiple departments and supervision to provide timely process and issue updates. Identifies and escalates issues or problems to appropriate supervision. Participates as a team member on cross-functional teams. Participates in reviews and structured processes for continuous improvement.

Responsibilities

• Performs physical inspection of in-process and finished product samples as assigned and according to the production schedule
• Collects samples from manufacturing and packaging according to the defined Batch Production Record and procedure requirements
• Becomes competent in at least one process: Weighing, Blending, Granulation, Compression, Coating, Encapsulation, Packaging
• Follows internal processes related to controlled substances
• Performs GMP related verifications such as line clearances, cleaning, room inspection, and materials
• Collects and appropriately labels packaging retain samples, and submits to the archive storage
• May execute computer data entries in CME, JDE, LIMS, and/or department databases
• Maintains collection of hold time study samples for QC analysis
• Collects and retains samples and performs sample evaluation for APR
• May backup third party product review/release
• Reviews, under close supervision, all pertinent records, including Batch Production Records and laboratory Certificates of Analysis to confirm accuracy and, with guidance, makes the determination of acceptability for product release
• Identifies errors that have potential product impact, escalates to supervision, and takes action to place lots on Quality Hold as needed
• Confirms that all Quality events (Change Controls, CAPAs, investigations and any other documentation related to the lot to be released) are complete and closed prior to product release
• Prioritizes reviews based on production and shipment schedules
• With guidance, reviews laboratory Certificates of Analysis for accuracy, communicates with the laboratory on COA discrepancies
• Performs MAPICS transactions to release product
• Collaborates with Quality and Manufacturing personnel to correct errors and address Non-Conformances in a timely manner
• Coordinates with production/ warehouse personnel to place material on Quality Hold as needed
• Responds to and escalates events identified during production to Quality Management
• Participates in investigations with the Rapid Response Team as needed
• Performs manufacturing and packaging room inspections and release
• Provides quality direction to operations to resolve floor issues, implement corrections, and assure deviations are opened
• Collaborates with Manufacturing and Quality partners to identify and implement improvements
• Follows all procedures to ensure a safe and compliant work environment

Requirements

• High School Diploma, and enrolled in a program for a B.A. /B.S. Degree in Science, Engineering, Business or related field or required experience
• Proof of academic enrollment must accompany application

Nice-to-haves

• B.A. or B.S. program with interest in Manufacturing environments; preferably industrial or mechanical engineering
• Previous Internship/Co-Op experience