Career Category

Job Description

SUMMARY

With minimal supervision, support the execution of manufacturing/quality systems such as deviations, CAPAs, change controls, procedures, training, and new product introductions.  Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations. 

FUNCTIONS

Deviation and CAPA

Ensure that all deviations are triaged within the established goal. Responsible for authoring investigation reports. Responsible for execution of corrective actions. Responsible for managing Deviation/CAPA closure within established goal. Monitor and communicate incidents trends. Review equipment/system Root Cause Analysis investigations and support trend evaluations. Accountable for meeting deadlines on all assigned compliance related actions.

Applied Process Expertise

Initiate, revise, and approve manufacturing procedures.  Ensure all procedures reflect current operations. Serve as a document owner. Assess process performance by observation of floor operations and review of performance data.  Evaluate, plan, and implement solutions for process improvement opportunities. Provide troubleshooting support. Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process.

Regulatory

May participate in regulatory inspections

New Product Introductions & Process or Equipment Modifications

Participate in the NPI process to assess requirements for documentation, materials, training, and equipment modifications. Assess, prioritize, justify, and provide implementation and project management support for process or equipment modification projects.

Projects and Initiatives

Participate on the assessment or implementation of special projects or initiatives.

EDUCATION

B.A./B.S. in Biology/Life Science/Engineering or the equivalent combination of education and experience.

RELEVANT EXPERIENCE

5  years' related and increasingly complex manufacturing experience

COMPETENCIES/SKILLS

• 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.
• Good project management skills.
• Basic knowledge of control charting.