Validation Analyst 1 Job at PCI Pharma Services (Rockford)

Job Description

The Validation Analyst I is responsible for overall validation project management of small customer account(s) under heavy supervision. Responsible for generation and execution of validation protocols, assistance in customer audits, and determination of customer validation needs. This job has no supervisory responsibilities.

Job Responsibility

Performs validation activities to assure compliance to government and customer requirements
Prepares validation protocols, validation statements, and master validation plans for new customer / product / system project launch and maintaining existing validated processes / programs at multiple sites as well as organizing and coordinating internal and customer approvals as needed
Ensures validation package documentation completion, accuracy, and closure including organizing and coordinating internal and customer approvals
Prepares change control and validation history report for customer audits
Attends conference calls and customer meetings and effectively communicates project goals and progress to Validation Supervisor / Manager
Investigates validation deviations, documenting in formal reports, and assuring resolution of corrective action to complete project
Customer contact for quality validations activities and manage customer expectations
Reviews and interprets customer standards, procedures and specifications for dissemination relative to process and cleaning validation protocols
Reviews production jacket and issuance to ensure that documents meet internal requirements for standards and procedures
Knowledge of and adherence to all PCI, cGMP, GCP, GAMP, 21CFR, 21CFR Part 11 and Annex 11 policies, procedures, rules, and requirements
This position may require overtime and/or weekend work
Attendance to work is an essential function of this position
Performs other duties as assigned

Requirements

High School Diploma or GED and/or 1-3 years related experience and/or training
Basic Mathematical Skills
Basic Computer Skills: Ability to perform basic computer tasks and has the ability to operate common computer programs
Minimum Professional Proficiency: 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
Required to pass and complete a “Documentation Boot Camp” course

Nice to have

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

What we offer

paid time off
health insurance coverage (including dental and vision)
flexible spending account
401(k)
eligibility for an annual performance bonus

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Validation Analyst 1

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