Quality Assurance Auditor II

BASIC SUMMARY:

Perform audits of protocols, raw data and final reports of medium complexity for routine and specialty assays, process documentation and labeling to assure accuracy and compliance with current Good Manufacturing Practice Regulations (GMP) and Standard Operating Procedures (SOP) and policies. Perform reviews of incoming, and in-process materials, with the authority for subsequent approval or rejection of these items against material specifications. Actively participate in hosting sponsor audits, and performing internal audits of Quality Systems. Participate in collecting and reporting of site quality metrics and qualification audits of subcontractors.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES:

· Review SOPs, protocols and other controlled documents of basic complexity for compliance with all pertinent GMP regulations and internal policies.

· Review and approve or reject all incoming raw material receipt packages for compliance with the requirements detailed in material specifications and applicable testing procedures.

· Review environmental monitoring data to ensure levels are in compliance with alert and action limits.

· Perform raw data audits of documentation for temperature, humidity, and magnehelic gauges monitoring environmentally controlled areas, and autoclave/oven charts to ensure accuracy and compliance with the GMP regulations, protocols and SOPs.

· Review and approve final reports to ensure accuracy and compliance with GMP regulations and the protocols; ensure that the final report accurately describes the raw data and test methods.

· Perform internal audits of Quality Systems (process/facility inspections/equipment and record review/computer validation activities/training records) to ensure compliance with current procedures.

· Determine and assure that exception documentation is appropriately reported and documented.

· Participate in the preparation for and hosting of Sponsor site visits.

· Participate in qualification audits of subcontractors as requested.

· Provide support during government/agency inspections as requested.

· Participate in Quality Assurance projects as requested.

· Perform all other related duties as assigned.

 

QUALIFICATIONS:

· Education: Bachelor’s degree (B.S./B.A.) or equivalent, preferably in a life science or related discipline.

· Experience:  Minimum of 2 to 4 years in a Quality Assurance role.

· An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.

· Certification/Licensure: N/A

· Other:  Knowledge of Microsoft Office ® applications and spreadsheet programs such as Access and Excel. This position requires the individual to comprehend regulations and guidance documents and apply critical thinking skills to evaluate requirements and effectively communicate (written and oral) findings.