: Sr Associate- Data Engineer (JP7669)
Thousand Oaks, CA
: 12 months with likely extensions
Job posting date
: 9 September 2020
Remote until COVID-19 restrictions are lifted.
3 Key Consulting is hiring a Sr Associate
for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.
- Candidate will be working remotely until the site reopens.
- Candidate will be working PST.
- Must have Pharma or Biotech experience.
- Purpose of role: support method and product trending, levitate quality system heavy work & supporting product control limits.
The Attribute Sciences Data Engineering (ASDE) group provides scientific and technical engineering expertise in support of Client’s pipeline and commercial portfolio. This team applies advanced data & computational analytics to advance products across all stages of therapeutic development.
This position will provide support to Client’s’s pipeline through support of Client’s quality systems as it relates to commercial product quality data monitoring. This position will support the quality related activities within the ASDE group. Responsibilities will include Quality Record ownership, SOP revision, authoring of GMP reports, ad-hoc data transcription and data verification support as well as collaboration with a cross-functional team to understand the scope and needs of product quality leads within the product data monitoring program.
- Use Client’s quality systems (e.g., Trackwise) to document and coordinate the investigation into product data signals.
- Own and revise SOP’s related to product data monitoring.
- Author and revise reports summarizing the calculation of product data monitoring limits within Client’s Document Management system.
- Provide data transcription and data verification support as needed for documents (e.g., Excel files)
Master’s degree OR Bachelor’s degree and 2 years of scientific or engineering experience OR Associate’s degree and 6 years of scientific or engineering experience OR High school diploma / GED and 8 years of scientific or engineering experience
Top Must have Skill Sets:
- Experience and understanding of cGMP.
- Experience in quality systems.
- Experience with SOP authoring and revision.
- Able to adapt to changing business needs and operational requirements.
- Ability to deliver high quality results in a timely manner.
- Excellent written and verbal communication.
- Strong leadership skills and decision-making abilities
- Demonstrated ability to work under minimal direction.
- Ability to multi-task and function in a dynamic environment.
- Ability to solve difficult, non-routine analysis problems, applying advanced analytical methods as needed
Employee Value Proposition:
- Experience and understanding of cGMP
- Experience in quality systems
- Experience with SOP authoring and revision, 2+ years
Opportunity to join a fast-paced team that applies advanced data & computational analytics to advance products across all stages of therapeutic development.
No computer experience
initial phone screen followed by video interview with additional team members.
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 look at other positions on our website www.3keyconsulting.com
. You are welcome to also share this posting with anyone you think might be interested in applying for this role.