Intern- Quality

BioTissue Holdings Inc

12d

About The Position

This internship offers an exciting opportunity to gain hands-on experience in the biopharmaceutical industry, supporting the development and maintenance of BioTissue’s Quality Management Systems (QMS). The Quality Systems Intern is a critical role within the Quality Systems team, responsible for ensuring the integrity of the Quality Management System through effective management of supplier quality activities, nonconformance and complaints investigations, and continuous improvement initiatives. This position involves collaboration across cross-functional teams to drive compliance with company procedures and regulatory standards, ensuring the delivery of high-quality products and services. The role includes overseeing supplier qualification and performance, supporting CAPA and change control processes, and coordinating QMS records to meet core quality system policies. The Quality Systems Intern will also lead product and process improvement efforts, apply statistical analysis for root cause identification, and participate and support in audits, complaint handling, and related quality activities. The successful candidate will play a pivotal role in fostering a culture of quality, compliance, and ongoing enhancement of the organization’s QMS.

Requirements

Must be a currently enrolled undergraduate student and entering junior or senior year (3rd or 4th year) prior to internship start date

Responsibilities

Track on-time status of open quality records within the QMS and escalate timeliness trends to management
Perform all Supplier Quality activities, including supplier qualification and system maintenance, supplier corrective actions and Quality Agreements for suppliers and/or Distributors
Collaborate on Corrective and Preventive Actions (CAPA) by tracking action items, gathering evidence, and assisting in closure process
Support implementation of change control processes to ensure compliance with company procedures and regulations
Participates in the nonconformance process to ensure timely completion /resolution of investigations and associated corrective actions
Coordinate and manage related QMS records ensuring these are handled according to the core quality system policies and procedures
Support quality and functional teams in performing initial assessment and categorization of new records
Provide support in cross-functional teams in investigations, CAPAs, Change requests, audits, and/or complaint handling events
Interacts with cross-functional teams to resolve quality issues. with cross-functional teams to resolve quality issues
Lead and Assist with the creation of master audit checklist
Managing returned complaint samples for evaluation as needed and applicable to the investigation of reported complaints
Lead product/ process improvements efforts related to the core quality systems of nonconformance, CAPA, change management, complaint handling, audit, supplier quality as assigned
Applies statistical tools to analyze data and identify root cause and problem resolution
Continually assess the Quality Management System and related procedures for continuous improvement