Validation Analyst 1
$19,960–$22,460 year
On-siteRockford, Illinois, United States
Rockford, Illinois, United StatesOn-siteFull Time$19,960–$22,460 yearHigh School Or EquivalentLarge
Full TimeHigh School Or EquivalentLarge
Job Summary
Execute validation protocols, prepare master validation plans, and manage documentation for customer account launches and existing programs. Coordinate internal and customer approvals, investigate deviations with formal reporting, and prepare change control history for audits. Communicate project goals to the Validation Supervisor during meetings and maintain compliance with cGMP, GCP, and 21CFR standards. This role requires overtime and weekend work as an essential function. Join PCI Pharma Services to drive operational excellence and deliver life-changing therapies to patients globally.
Required Qualifications
- High School Diploma or GED
- 1-3 years related experience and/or training
- Basic Mathematical Skills
- Basic Computer Skills
- Ability to perform basic computer tasks
- Ability to operate common computer programs
- Ability to speak in a way that allows one to participate effectively in various conversations
- Ability to read various types of standard items addressed to general readers
- Intermediate Reasoning
- Ability to apply common sense understanding to carry out instructions that may be furnished in written, oral, or diagram form
- Ability to deal with problems that involve several concrete variables in standardized situations
- Knowledge of and adherence to all PCI, cGMP, GCP, GAMP, 21CFR, 21CFR Part 11 and Annex 11 policies, procedures, rules, and requirements
- Ability to pass and complete a Documentation Boot Camp course
- Availability for overtime and/or weekend work
Desired Qualifications
- Ability to demonstrate attention to detail
- Ability to work independently and/or part of a team
- Ability to follow instructions and respond to management direction
- Ability to adapt to changing work environments
- Ability to display a willingness to make decisions
- Ability to effectively communicate information to various people as the job requires
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