Perform one or more of the following duties and responsibilities in support of Amgen’s Quality Assurance program under minimal supervision
1.Review and approve product MPs.
2.Approve process validation protocols and reports for manufacturing processes.
3.Request Quality on incident triage team.
4.Approve Environmental Characterization reports.
5.Release of sanitary utility systems.
6.Approve planned incidents.
7.Represent QA on NPI team.
9.Lead site audits.
10.Own site quality program procedures.
11.Designee for QA manager on local CCRB.
12.Review Risk Assessments
13.Support Automation activities
14.Support facilities and environmental programs
15.Review and approve Work Orders
16.Review and approve EMS/BMS alarms
17.Approve NC investigations and CAPA records
18.Approve change controls
19.Provide lot disposition and authorize lots for shipment
* Other functions that may be assigned
Bachelor’s degree in Life Science & 5 years of directly related experience
Master’s degree in Life Science & 3 years of directly related experience
•Project management skills
•Strong organizational skills, including ability to follow assignments through to completion
•Initiate and lead cross functional teams
•Enhanced skills in leading, influencing and negotiating
•Strong knowledge in area of expertise
•Collaborate and coordinate with higher level outside resources
•Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QC, validation and process development
•Demonstrate ability to interact with regulatory agencies
•Strong word processing, presentation, database and spreadsheet application skills
•Strong communication (both written and oral), facilitation and presentation skills
•Strong skill in working independently and to effectively interact with various levels
•Advanced data trending and evaluation
•Ability to evaluate compliance issues
•Demonstrate the Amgen Values/Leadership Practices
Amgen - 19 months ago
Amgen is among the biggest of the biotech big'uns, and it's determined to get even bigger. The company uses cellular biology and medicinal...