Job Description

Job Responsibilities:

• Compile and perform lot file review including assessment of manufacturing records, test method data, deviations for GMP compliance to enable lot release, specifically:
• Review executed batch production records and test data to ensure compliance with approved procedures and GMP expectations
• Review certificates of analysis c. Evaluate discrepancies noted during batch record reviews d. GMP incident/deviation review
• Apply the principles of good quality systems and GMP, as assigned on a daily basis
• Create and revise standard operating procedures (SOP’s) as needed
• Assist with the reporting and presentation of department metrics includes input into reports to Management, annual product quality reviews and process monitoring
• Assign part and lot numbers and maintain logs
• Periodic review of validated systems
• Review validation deliverables for compliance with Seattle Genetics policies and procedures

Skills:

• Demonstrated experience in a biotechnology manufacturing or laboratory environment
• cGMP

Education/Experience:

• High School

Job Tags

Similar Jobs