Senior Validation Analyst – 2nd Shift, GMP Compliance

PCI TRGR Penn Pharmaceutical Services Ltd

Rockford (IL)

Hybrid

USD 37,000 - 43,000

Full time

14 days+
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Benefits offered by this job

Paid time off
Health insurance (including dental and
Vision coverage)
401(k) plan
Flexible spending account

Job summary

PCI is hiring a Validation Analyst III in Rockford, IL. The role focuses on managing validation projects for major customers, drafting protocols and validation plans, and coordinating with teams and clients to meet regulatory standards.

The position emphasizes accurate documentation, audit support, and timely issue resolution, with additional responsibilities as needed. A 2nd shift with 10% premium is noted in the posting.

Qualifications

  • Associate degree or related experience required; college math skills essential.
  • Proficiency with business software and data handling tasks.
  • Fluent English, strong problem solving and communication abilities.
  • Ability to present information clearly to diverse audiences.

Responsibilities

  • Manage validation projects for large customer accounts with minimal supervision.
  • Prepare validation protocols, statements, and master plans for launches.
  • Coordinate internal and customer approvals and audit support.
  • Investigate deviations and document CAPAs to close validation activities.
  • Communicate progress to Validation Supervisor/Manager and customers.

Skills

Math skills
Computer skills
English fluency
Reasoning skills
Presentation skills

Education

Associate degree

Job description

PCI is hiring a Validation Analyst III in Rockford, IL. The role focuses on managing validation projects for major customers, drafting protocols and validation plans, and coordinating with teams and clients to meet regulatory standards.

The position emphasizes accurate documentation, audit support, and timely issue resolution, with additional responsibilities as needed. A 2nd shift with 10% premium is noted in the posting.

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