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Job description
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
2nd Shift: Additional 10% Shift Premium
Summary of Objective
The Validation Analyst III is responsible for overall validation project management of large customer accounts under minimal 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.
Required to pass and complete a "Documentation Boot Camp" course.
Essential Duties and Responsibilities
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.
Performs other duties as assigned.
This position may require overtime and/or weekend work.
Attendance to work is an essential function of this position.
Qualifications
Required
Associate's Degree in a related field and/or 1-3 years related experience and/or training.
College Level Mathematical Skills
Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs.
Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms.
Preferred
Ability to effectively present information to various people as the job requires.
Ability to follow instructions and respond to management direction.
Ability to identify and resolve problems in a timely manner.
Ability to display a willingness to make decisions.
Ability to display excellent time management skills.
Ability to set and achieve challenging goals.
The hiring rate for this position is $27.27-$30.68 plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise.
PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and a 401(k) plan.
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Join us and be part of building the bridge between life changing therapies and patients. Let's talk future
Equal Employment Opportunity (EEO) Statement
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We ar
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Worksite address
rockford, IL, 61103, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.