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MUST HAVE:
Experience in cleaning validation in the biologics or vaccine industry to include the following:
o Experience in authoring, reviewing, executing and approving validation documents.
o Interface with Quality organization and the ability to defend rationale in validation documents.
o Ability to d evelop cleaning cycle and l ead the investigation or trouble shooting.
o Ability to review and analyze data.
" Cleaning Validation experience
o Acceptance criteria determination
o Sampling plans and sample size determination
o Rinse and Swab sampling experience
o Bracketing and worse case rating
o QC testing requirements
o Dirty hold times and clean hold times
EXCELLENT communication skills
Ability to manage, execute and troubleshoot on their own
Strong Microsoft Suite skills (Word, Excel, Project, Outlook)
REQUIREMENTS:
BS/MS degree
2+ total years of experience working in a biologic, vaccine or pharma industry
Experience writing and revising documents (e.g. testing methods, protocols, reports)
Experience performing testing in a GMP setting
Proficiency in utilizing documentation system to author protocols and reports
Experience participating in teams and collaborative work environments.
Team environment a must
E Doc/GEODE+ experience with a working knowledge of templates, workflows and approval process
Strong root cause analysis with cGMP experience.
Mainly M-F with some flexibility in working hours. Will work some form of 8 hours within 7am and 5pm. Manager flexible. Must be open to very occasional weekend work or overtime if needed. May also need to switch a shift from morning to afternoon on occasion.
Start ASAP with possibility to extend after December 2024.
Mostly hybrid - will usually be 4 days onsite and one remote but manager prefers flexibility just in case they are needed onsite the extra day.
Date Posted: 20 May 2024
Job Expired - Click here to search for similar jobs