Job Title: Specialist Manufacturing-Remote (JP9903)
Location: Thousand Oaks, CA 
Employment Type: Contract
Business Unit: Medical Device Supply & Raw Materials
Duration: 12 months with likely extensions
Job posting date: 3/2/2022
Note: Remote

​3 Key Consulting is hiring a Specialist Manufacturing-Remote for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.

Job Summary:
Responsibilities include, but are not limited to the following:

• 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.
• 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 Amgen 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

Top Must have Skill Sets:

• Project management skills and use of project management software tools
• Understanding of biopharmaceutical or pharmaceutical manufacturing
• Knowledge of Good Manufacturing Processes (GMPs)
• Bachelors in biology or chemistry related field (Biology, Biochemistry, Chemistry, etc.)

Day-To-Day Responsibilities:
Initiate and own quality records (Deviations, CAPAs and Change Controls) that are generated from defects with our raw materials

Employee Value Proposition:
Growth and opportunity


Red Flags:
Excessive job hopping with short durations at each position

Interview Process:
One interview which will be virtual through WebEx with manager and one of his group leads


 
We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.