RFD_Validation Analyst 3

pciservices; Rockford (IL); On-site; USD 38,000 - 42,000; Full time

Benefits offered by this job

Annual performance bonus

Health insurance

Dental and vision coverage

401(k) plan

Paid time off

Job summary

PCI Pharma Services is seeking a Validation Analyst III to manage validation projects for large customer accounts with minimal supervision. You will generate and execute validation protocols, assist in customer audits, and determine validation needs across multiple sites.

The role requires completing a Documentation Boot Camp and entails overtime/weekend work. You will interact with Validation Supervisors/Managers and handle change control, deviation investigations, and customer communications

Qualifications

• Associate's Degree in a related field and/or 1-3 years related experience and/or training.
• College level mathematical skills.
• Intermediate computer skills with ability to perform complex tasks.
• Full professional proficiency in speaking, reading, and writing.
• High reasoning to solve practical problems with limited standardization.

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 projects.
• Maintains validated processes across multiple sites and coordinates internal and customer approvals.
• Prepares change control and validation history reports for customer audits.
• Attends conference calls and customer meetings; communicates goals and progress.
• Investigates deviations, documents reports, and ensures corrective action completion.
• Serves as customer contact for quality validation activities and manages expectations.
• Reviews customer standards and specifications for dissemination related to validation protocols.
• Reviews production jackets and issuances to ensure documents meet internal standards.
• Performs other duties as assigned.

Skills

Math skills

Intermediate computer skills

Full professional proficiency

High reasoning

Education

Associate's degree in a related field

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