Manufacturing Senior Associate SOP Technical Writing JP9811
Manufacturing Senior Associate SOP Technical Writing JP9811
Posted on :
11-04-2025
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1 Vacancy
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Monthly Salary
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Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
11-04-2025
Job Description
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 Associatefor 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:
Why is the Position Open
Supplement additional workload on team.
Top Must Have Skills:
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 sendyour resume to. Ifyou decide that youre not interested in pursuing this position please feel free to look at the other positions on our websitewww.3keyconsulting/careers. You are welcome to also sharethis opportunity withanyone you think might be interested in applying for this role.
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 Associatefor 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 crossfunctional 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 crossfunctionally across the site to ensure maturity and 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.
- Bachelors degree and 12 years of Manufacturing or Operations experience OR
- Associates degree and 4 years of Manufacturing or Operations experience OR
- High school diploma / GED and 7 years of Manufacturing or Operations experience
- 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 crossfunctional/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 fastpaced 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 riskbased 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 sendyour resume to. Ifyou decide that youre not interested in pursuing this position please feel free to look at the other positions on our websitewww.3keyconsulting/careers. You are welcome to also sharethis opportunity withanyone you think might be interested in applying for this role.
Regards
3KC Talent Acquisition Team
Required Experience:
Senior IC
Employment Type
Full Time
Key Skills
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