2026 Co-Op, R&D Quality

Role Summary

2026 Co-Op, R&D Quality

Responsibilities

• Support QA audits of laboratory deliverables, gaining firsthand experience with GLP and GCP.
• Assist in review of validation and lifecycle management compliance to meet internal standards.
• Collaborate with team members to develop and maintain laboratory systems compliant with regulations and guidelines.
• Contribute to risk impact assessments and evaluate potential risks.
• Overview of audit study materials and reports for nonclinical, biomarker and bioanalytical studies.
• Assist audit team with audit deliverables, CAPAs and responses.
• Trending of metrics and KPIs related to department activities.

Qualifications

• Currently pursuing a degree in Life Sciences, Health and Human Services or related field.
• Basic understanding of GLP and GCP requirements, lifecycle controls and the drug development process, as well as Quality Assurance (QA), clinical development and clinical sample analysis.
• Basic familiarity with pharmaceutical regulations (GLP/GCP) is a strong plus.
• Prior experience or coursework in Quality Assurance is a plus.
• Proficient with Microsoft Office/365
• Candidates must already hold work authorization in the US and be able to maintain that status without the need for future sponsorship.

Skills

• Bioanalytical technology knowledge (preferred): LIMS, ELISA, Functional Assays, PCR, plate readers, mass spectroscopy.
• Critical thinking and problem solving skills.
• Working knowledge in cell/tissue culture, in vitro transfections, protein/antibody detection methods, molecular biology techniques, assay development and troubleshooting.
• Strong collaboration and communication skills.

Education

• Degree in Life Sciences, Health and Human Services or related field (pursuing).

Additional Requirements

• None specified beyond basic work authorization.