Careers
Manufacturing Associate
Job Description:
Performs review of documents, records and procedures supporting release of clinical and commercial GMP products and participates in development of GMP operations, as assigned. Performs review of validation documentation, periodic reviews of validated systems, and/or procedures, as assigned.
Responsibilities
1. Compile and perform lot file review including assessment of manufacturing records, test method data, deviations for GMP compliance to enable lot release, specifically:
a. Review executed batch production records and test data to ensure compliance with approved procedures and GMP expectations
b. Review certificates of analysis c. Evaluate discrepancies noted during batch record reviews d. GMP incident/deviation review
2. Apply the principles of good quality systems and GMP, as assigned on a daily basis
3. Create and revise standard operating procedures (SOP’s) as needed
4. Assist with the reporting and presentation of department metrics includes input into reports to Management, annual product quality reviews and process monitoring
5. Assign part and lot numbers and maintain logs
6. Periodic review of validated systems
7. Review validation deliverables for compliance with Seattle Genetics policies and procedures
Requirements:
Knowledge of cGMP and applicable FDA regulations; Detail oriented team player; Able to independently review documentation and identify gaps; Experience reviewing GMP documentation including protocols, reports, batch records and data; Ability to maintain logs, schedules; Ability to organize lot documentation, validation plans, protocols, data, and reports in controlled document system; Must be able to organize information in a consistent and retrievable manner; Ability to work effectively in a fast paced environment
Hard Skills:
1. cGMP
2. Time Management/Organizational skills
3. Ready to hit the ground running
Soft Skills:
1. Team Player
2. Independent
3. Punctuality
4. Communication
5. Willingness to learn