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Specialist Manufacturing, Biopharma - Remote (JP10101)

Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title:  Specialist Manufacturing, Biopharma - Remote (JP10101)
Location: Thousand Oaks, CA. (Remote work)
Employment Type:  Contract
Business Unit: Medical Device Supply and Raw Materials
Duration: 1+ years with likely extensions or conversion to FTE
Posting Date:  04/19/2022

3 Key Consulting is hiring a Specialist Manufacturing for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
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:
  • 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 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:
  • 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

Why is the Position Open?
Supplement additional workload on team.

Top Must-Have Skill Sets:
  • 1.Project management skills
  • 2.Understanding of Good Manufacturing Practices in the Biophamacuetical, Pharmacuetical, or Medical Device industries.
  • 3. Experience or knowledge of operations in the three industries listed above

Day to Day Responsibilities:
  • Manage and close quality records such as ENs. SICARs, CAPAs, and change controls by working with a crosso-functional team at client
  • Lead or participate in investigations

Red Flags:
  • Cannot have jumped from job to job over a short period of time.
  • Does not have a technical degree from a four year accredited university

Interview process:
Phone screening followed by in-person interview.

We invite qualified candidates to send your resume to resumes@3keyconsulting.com.  If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
Remote position
3KC Talent Acquisition Team
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