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Manufacturing Senior Associate, SOP Technical Writing  (JP9811)

Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title:   Manufacturing Senior Associate, SOP Technical Writing  (JP9811)
Location: Thousand Oaks, CA. 91320 (Hybrid, 50% onsite)
Employment Type:  Contract
Business Unit: Pilot Plant Downstream 
Duration: 12 months with likely extensions and/or conversion to permanent
Posting Date: 3/28/2022

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

Job Description:

The Manufacturing senior associate is expected to help own and execute SOP and MP revisions according to SOP revamp project. Bin items, Corrective Action and Preventative Action Plans and corrective verification items will also be paramount additions to new SOP format. Responsibilities include, but are not limited to the following:

General:
  • Working with peers and floor staff in functional areas for the implementation of best practices, streamlining of operations, and equipment handling into SOPs and MPs
  • Facilitation of cross-functional teams (internal and external to the site) with the goal of achieving robust and detailed standard operating practices
  • Communication of project status to Senior Leadership in multiple forums (as requested); maintaining the metric reporting for project performance
  • Partner cross-functionally across the site to ensure maturity and execution of robust SOPs and alignment opportunities
  • Provide timely and comprehensive progress of project scope and status updates to senior management
  • Build and present decision point summaries for Senior Management review
  • Help to identify and coordinate a team to include all company key partners and subject matter experts vital for roll out, and documentation adjustment process
  • Lead teams to identify unit op robust documentation strategies and easy ways of getting data to the data lake by effectively utilizing previous biotech experience and working with manager.
     
Basic Qualifications:
  • Bachelor’s degree and 1-2 years of Manufacturing or Operations experience, OR
  • Associate’s degree and 4 years of Manufacturing or Operations experience, OR
  • High school diploma / GED and 7 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
  • Some 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 working with 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

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

Top Must Have Skills:
  • Strong technical writing skills and versed in Microsoft office apps, SOP writing experience preferred.
  • Some biotech production experience preferred.
  • Organization. Successful candidate will show task oriented behavior in an organized fashion to allow for efficient work flow.
  • Working on production floor/ bio tech/ lab experience

Day to Day Responsibilities:
SOP and manufacturing procedure editing.


Employee Value Proposition:
Career growth / experience

Red Flags:

No science or biotech education or background
A PHD candidate would be overqualified for this role


Interview process:
Phone screen / WebEx with hiring manager

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

 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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