BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. We are currently looking for a QA Associate to work for a leading San Diego biotechnology company.
The Quality Assurance Associate is expected to have a complete understanding of FDA, OECD, and MHLW Good Laboratory Practices (GLP), as well as basic laboratory quality assurance procedures.
Represent and interact with multiple departments to provide GLP guidance in an effective manner.
Become intimately familiar with company Standard Operating Procedures (SOPs), FDA, OECD, and MLHW regulations, and other appropriate guidelines and regulations. Also be familiar with any sponsor SOPs that may apply to studies.
Review validation and project data for compliance to SOPs and Bioanalytical Procedures (BPs).
Determine that no deviations from approved protocols/plans or standard operating procedures were made without prior authorization and documentation.
Assure compliance with GLP regulations and company procedures (SOPs and BPs).
Troubleshoot and take the initiative on any QA-related issues with regards to GLP compliance.
Submit to Study Director and/or Study Facility Management periodic written reports of each study, noting any problems or corrective actions taken.
Assist with developing, revising, and reviewing SOPs. Perform SOP revision training, when necessary.
Assist with performing study phase (in-life) inspections to ensure compliance and integrity of the study.
Assist with maintaining training records of all employees.
Assist with performing facility inspections to ensure laboratory maintains compliance.
Support all other QA functions as required.
Bachelorâ€™s degree (BA or BS) required
1+ years of relevant experience in QA, QC, or within GXP (GCP, GLP, GMP) environment