36361865 Principal Specialist, Analytical Method Validation – Athens, GA (12-Month Contract)
Location: Athens, GA (Onsite)
Schedule: Monday – Friday, 9:00 AM – 5:00 PM (no shift work)
Duration: 12 Months
Company: Sigma Inc.
📌 About the Role
Sigma Inc. is seeking a Principal Specialist, Analytical Method Validation to support our client’s operations in Athens, GA . This role requires strong expertise in analytical method validation, regulatory compliance (FDA, USDA, EU, ICH), and scientific reporting . You will lead validation projects, coordinate with laboratory teams, and prepare regulatory documentation to ensure compliance with industry standards.
⚡ Key Responsibilities
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Write analytical method validation protocols in compliance with FDA, EU, and USDA regulations as well as corporate procedures.
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Provide oversight of validation projects and coordinate with laboratory staff on experimental test execution.
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Summarize laboratory validation test results into detailed validation reports .
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Collaborate with area managers on project management, regulatory documentation, timelines, and final USDA submissions .
✅ Requirements
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Bachelor’s degree in Biology, Microbiology, Chemistry, Biochemistry, or related scientific field.
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Hands-on experience with analytical method validation and regulatory requirements (USDA, ICH, FDA).
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Strong written and verbal communication skills for technical documentation and reporting .
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Working knowledge of scientific principles (microbiology, biological chemistry, biochemistry).
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Basic knowledge of pharmaceutical quality standards.
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Understanding of GLP/GMP regulations and compliance requirements.
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Preferred: Experience with writing change controls, conducting impact assessments, and IFA (Indirect Fluorescent Antibody) test methodology.
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Preferred: Laboratory and/or production facility experience.
Employment Type: CONTRACTOR