Description:
Perform one or more of the following duties and responsibilities in support of Quality Assurance program under minimal supervision. Review and approve product MPs.
Approve process validation protocols and reports for manufacturing processes.
Request Quality on incident triage team.
Approve Environmental Characterization reports.
Release of sanitary utility systems. Approve planned incidents.
Represent QA on NPI team.
Lead investigations.
Lead site audits.
Own site quality program procedures.
Designee for QA manager on local CCRB. Review Risk Assessments.
Support Automation activities.
Support facilities and environmental programs.
Review and approve Work Orders. Review and approve EMS/BMS alarms.
Approve NC investigations and CAPA records.
Approve change controls.
Provide lot disposition and authorize lots for shipment.
Education:
Master’s degree in Sciences/Engineering and 3 years of directly related experience or Bachelor’s degree in Sciences/Engineering and 5 years of Manufacturing experience in a GMP regulated industry
Preferred Qualifications:
Biotechnology industry experience:
Detailed technical understanding of bio-processing unit operations
Skilled in performance of GMP production operations
Regulatory knowledge and interactions
Participate and help lead cross-functional teams
Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality
Organizational, technical writing and presentation skills
Project management skills
Knowledge of control charting
Availability to support non-standard shift
Experience in Root Cause Analysis (Fishbone, 5 Why’s, Kepner Tregoe)
ISHIHARA TEST is required
Skills:
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, QAL, 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.
