Job Title: Technical Specifications Specialist – 95% remote (JP9616) Location: Thousand Oaks, CA. Employment Type: Contract Business Unit: Raw Material Specifications Duration: 12+ months (with likely extensions) Notes: Remote until covid restriction are lifted then once a month onsite. Posting Date: 1/11/2022
3 Key Consulting is hiring a Technical Specifications Specialist for a consulting engagement with our direct client, a leading global biopharmaceutical company.
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).
Other responsibilities include Quality System record ownership including change control, master data change control, deviation, and CAPA.
Own Material Specification activities:
Draft specifications based on raw material attributes, where they are used in the Amgen process and how they should be controlled
Facilitate specification development meetings
Generate meeting minutes/action items to partners to ensure completion of task
Own Master Data onboarding activities:
Create and own Master Data Changes in Trackwise
Determine master data strategy for inclusion on BOMs
Ensure Animal Derived Material tissue and origin correctly identified in SAP
Manage material creation workflows by ensuring SAP data agents complete all tasks on time to meet onboarding need-by date
Coordinate with site warehouse, purchasing and accounting teams
Ensure material status is updated for use at manufacturing sites
Why is the Position Open? Planned Project.
Top Must-Have Skill Sets:
Background in Life Science or Engineering (Biochemistry, Analytical Chemistry
Bio-Manufacturing, Process development, Chemistry, Biology, Engineering).
Basic Qualifications: Degree in Life Science or Engineering (Biochemistry, Analytical Chemistry, Bio-Manufacturing, Process development, Chemistry, Biology, Engineering).
Employee Value Proposition: This role is very versatile and will require you to communicate to different levels of the organization.
Interview process: Phone screening followed by panel interview.
We invite qualified candidates to send your resume to firstname.lastname@example.org. If you decide that you’re not interested in pursuing this position, please feel free to take a 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.