
Analytical Instrumentation Specialist
3 weeks ago
They play a vital part in verifying that instruments meet regulatory requirements and industry standards.
"Key Responsibilities: " "" "Conduct qualification assessments on analytical instruments to ensure they meet regulatory and industry standards.
" "Develop and execute qualification protocols for analytical instruments, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
" "Collaborate with cross-functional teams to align on qualification processes and requirements.
" "Maintain accurate documentation and records of qualification activities.
" "Troubleshoot issues during qualification and implement corrective actions.
" "Stay updated on industry trends, regulations, and best practices related to analytical instrumentation qualifications.
" "Provide technical expertise to internal teams on instrument qualification and maintenance.
" "Continuously improve qualification processes to enhance efficiency, accuracy, and compliance.
" "Requirements: " "" "Bachelor's or master's degree in chemistry, Analytical Chemistry, or a related field with 10+ years of experience.
" "Solid understanding of analytical instrumentation principles and technologies.
" "Proven experience in qualifying and validating analytical instruments like HPLC, GC, UV, FTIR, KFT, Balances, etc.
" "Knowledge of software validation, software operation of CDS like Empower, Chromeleon, etc.
" "Familiarity with relevant regulatory requirements and standards, such as FDA regulations and GMP guidelines.
" "Strong analytical and problem-solving skills with ability to troubleshoot and resolve issues.
" "Excellent documentation and record-keeping abilities with attention to detail.
" "Effective communication and interpersonal skills with ability to collaborate and liaise with cross-functional teams.
" "),
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