Specialist Manufacturing

Description:

REMOTE

The Specialist Manufacturing is expected to own and execute Change Controls, Supplier Investigations, Corrective Action and Preventative Action Plans and corrective verification along with Supplier event notifications. Responsibilities include, but are not limited to the following:

General:
Mentoring and leading of peers in functional areas and Quality Operations in the implementation of investigations of varying complexity
Facilitation of cross-functional teams (internal and external to the site) with the goal of achieving robust and detailed investigation performance
Communication of Quality System status to Senior Leadership in multiple forums (as requested); maintaining the metric reporting for site performance
Partner cross-functionally across the site to ensure maturity and execution of robust NC/CAPA process
Support regulatory inspections by directly collaborating with inspectors to present NC/CAPA process overviews as well as individual investigations
Prepare defense strategies in support of regulatory inspections and internal audits
Provide timely and comprehensive process and investigation status updates to senior management
Build and present investigation summaries for Senior Management review
Identify and coordinate an investigation team to include all Our Client key partners and subject matter experts vital for a complete investigation
Develop and lead the implementation of investigation plans for nonconformances
Lead investigation teams to identify meaningful root causes and robust corrective and preventative actions by effectively utilizing advanced root cause analysis tools (Causal Factor Analysis, Fault Tree Analysis, Kepner-Tregoe, etc.)
Basic Qualifications:
Doctorate degree, OR
Master's degree and 3 years of Manufacturing or Operations experience, OR
Bachelor's degree and 5 years of Manufacturing or Operations experience, OR
Associate's degree and 10 years of Manufacturing or Operations experience, OR
High school diploma / GED and 12 years of Manufacturing or Operations experience

Preferred Qualifications:
Scientific degree in Life Sciences or Physical Sciences, Applied Engineering or Manufacturing Technologies
Biotechnology or Pharmaceutical experience
Project Management and/or Quality Management skills and experiences
Experience leading cross-functional/site investigation teams in complex deviations including determination of potential product impact, root cause, and corrective and preventative actions
Experience in leading multiple, contending priorities in a fast-paced environment with minimal direction
Proven leadership traits
Excellent communication skills, both written and verbal (including technical writing and presentations) with ability to collaborate productively with technical and senior management staff
Ability to solve complex problems and make scientific risk-based decisions
Experience presenting to and interacting with representatives of regulatory agencies
Trackwise database experience
Direct bulk and fill and finish manufacturing experience
Aseptic processing knowledge and/or practical experience
Competencies:
Passion for Operational Excellence
Communications skills, both oral and written, including presentation skills
Interpersonal and facilitation skills necessary to forge consensus among challenging client interests while ensuring objectives are met
Ability to tactfully negotiate and positively influence peers and executive leadership
Analytical skills to identify potential improvement opportunities