With minimal supervision, support the execution of manufacturing/quality systems such as non-conformances and CAPAs. Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations.
Applied Process Expertise
Initiate, revise, and approve manufacturing investigations. Serve as a investigation owner.
Assess process performance by observation of floor operations and review of performance data. Evaluate, plan, and implement solutions for process improvement opportunities
Assist in generation of corrective and preventive actions and may assist in providing guidance on technical aspects of the process
Support establishment of process monitoring for non-conformance trends
Provide support of timely execution of the NC trending monitoring quarterly reports
Non-Conformance and CAPA
Ensure that all Non-conformances are triaged within the
Responsible for authoring investigation reports.
Responsible for execution of corrective actions.
Responsible for managing NC/CAPA closure within established goal.
Monitor and communicate incidents trends.
Review equipment/system Root Cause Analysis investigations and support trend evaluations.
** Other functions may be assigned.
Basic Education & Experience
Bachelor’s degree in Biology/Life Science/Engineering & 5 years of directly related experience
Master’s degree & 3 years of directly related experience
Detailed technical understanding of bioprocessing 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.
Basic project management skills.
Basic knowledge of control charting.
Amgen - 14 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...