Technical Specifications Specialist (Jp7721)
3 Key Consulting
Thousand Oaks, , CA 91320
Posted 3 weeks ago
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: Technical Specifications Specialist (JP7721)Location:
Thousand Oaks, CAEmployment Type
: 12 months with likely extensionsJob posting date
: 5 October 2020Note:
Remote until COVID-19 restrictions are lifted.3 Key Consulting is hiring aTechnical Specifications Specialist
for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.Job Summary:
Top Must have Skill Sets:
- Manage the development and implementation of clinical and commercial raw material specifications and other specification related documents.
- Have an understanding and knowledge of raw materials used in the manufacturing of biologics and small molecules (Media, Chemicals, Excipients, Single-Use Components, Filters, Resins, Primary Containers).
- Interface cross-functionally within client (with Process Development, Quality, Supply Chain and other GMP functions) and externally with the client raw material suppliers.
- Draft specifications based on raw material attributes, where they are used in the client process and how they should be controlled.
- Facilitate specification development meetings and generate meeting minutes/action items to partners to ensure completion of tasks.
- Other responsibilities include acting as a change owner and initiator as part of the Change Control Management System (CCMS) to document changes to global documents in a compliant manner.
- Skills:Degree in Life Science or Engineering (Biochemistry, Analytical Chemistry, Bio-Manufacturing, Process development, Chemistry, Biology, Engineering); preference will be given to advance degree holders and/or those who have industry and project management experience.
- Targeting PHD/Master level candidates with 6 months work experience or more.
- Knowledge of analytical methods (depends on education)
- Data Analytics experience.
- Troubleshooting experience.
- Soft skills-team player ,problem solver
Manage the development and implementation of clinical and commercial raw material specifications and other specification related documents. Facilitate specification development meetings and generate meeting minutes/action items to partners to ensure completion of tasks. Other responsibilities include acting as a change owner and initiator as part of the Change Control Management System (CCMS) to document changes to global documents in a compliant manner.Employee Value Proposition:
Huge cross collaboration for this project, working at a biotech/pharma company, technical documentation experience growth, project exposure to multiple departmentsInterview Process:
Phone interview - skype/webex interviewWe invite qualified candidates to sendyour resume email@example.com. Ifyou decide that youre not interested in pursuing this position, please feel free to look at other positions on our websitewww.3keyconsulting.com
. You are welcome to also sharethis posting withanyone you think might be interested in applying for this role.