What are the responsibilities and job description for the QC Validation Support position at Tech Observer?
Job Description
Job Title: QC Validation Support (QC Expert)
Location: Carlsbad, CA
Duration: 06 months contract with possible extension
ONSITE POSITION
Summary
Carlsbad site is installing new instruments and software in the laboratory that will require validation work for the new QC l
ab.As a part of the onboarding of new QC equipment and instruments for the project, multiple QC instruments, and QC support equipment will require validation, qualification work to meet QC testing demands. Equipment including but not limited to:- UPLCs, Dose Calibrators, Air Samplers, Particle Counters, Endosafe PTS, iTLC Scanner, Balance, pH Meter.
Provide validation support which shall include but not limited to the following it
ems:Provide support for Commissioning and Qualification activities for the required additional equipment and instrume
nts.Author and execute Commissioning and Qualification documents, including, but no limited to: URS, Qualification Plans, Development Protocols, Risk Assessments, Qualification Protocol(s) including deviation support during physical execution, Qualification Repo
rts.Collaborate and work directly with team members to complete project deliverables. Ensure to stay informed on general project information including but not limited to decisions, changes, plans of work, due dates, and issues. Attend project meetings related to implementation, document reviews, and schedule reviews. Track deliverables and milestones and escalate delays to Validation Management. Escalate project or technical changes, issues, risks, and outstanding decisions to Validation Management
Education & Experience
Bachelor's degree
3-5 years of related experience required
