Medical Engineering Consultants (MEC)
QC Chemistry Data Reviewer
Medical Engineering Consultants (MEC), Lexington, Kentucky, us, 40598
Overview
Medical Engineering Consultants (MEC) support medical device and pharmaceutical companies by providing expertise and resources to improve efficiency and productivity. Our vision is to align client needs with the best available marketplace resources. We proactively create roadmaps that validate processes, ensure compliant quality systems, and close gaps between current and FDA expected stages. Role Responsibilities
Conduct thorough and timely review of raw data, laboratory notebooks, and other documentation related to testing of raw materials, in-process samples, finished products, and stability samples. Verify calculations, chromatograms (HPLC, GC), and other test results for accuracy, completeness, and adherence to applicable test methods and protocols. Ensure all documentation complies with ALCOA+ and Good Documentation Practices (GDP). Collaborate directly with chemists to resolve data inaccuracies and documentation issues. Review audit trails for computerized systems (e.g., Empower) to verify data integrity and proper system usage. Basic Qualifications
Bachelor’s degree in a life science field such as Chemistry or Biochemistry. 2–5 years of experience in a pharmaceutical analytical laboratory or quality control environment with laboratory data review responsibilities. Strong knowledge of analytical techniques including HPLC, GC, UV‑Vis, and FTIR. Proficiency with chromatographic data systems such as Empower. Thorough understanding of cGMP, GDP, and data integrity principles. Knowledge of relevant regulatory guidelines (FDA, ICH). Preferred experience with medical device testing. Exceptional attention to detail and strong written and verbal communication skills. Effective organizational and time‑management skills to handle multiple priorities. Ability to work independently and collaboratively. Physical Demands
Regular use of hands to handle materials and supplies. Extensive computer use and electronic communication. Regular standing and walking for extended periods. Occasional lifting or moving up to 20 pounds. Following proper PPE and site safety procedures. MEC does not accept unsolicited resumes from search firms or staffing agencies. All unsolicited resumes are considered the property of MEC and no placement fees will be paid. Reasonable accommodations may be made for individuals with disabilities. MEC is an equal opportunity employer. AAP/EEO DFWP.
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Medical Engineering Consultants (MEC) support medical device and pharmaceutical companies by providing expertise and resources to improve efficiency and productivity. Our vision is to align client needs with the best available marketplace resources. We proactively create roadmaps that validate processes, ensure compliant quality systems, and close gaps between current and FDA expected stages. Role Responsibilities
Conduct thorough and timely review of raw data, laboratory notebooks, and other documentation related to testing of raw materials, in-process samples, finished products, and stability samples. Verify calculations, chromatograms (HPLC, GC), and other test results for accuracy, completeness, and adherence to applicable test methods and protocols. Ensure all documentation complies with ALCOA+ and Good Documentation Practices (GDP). Collaborate directly with chemists to resolve data inaccuracies and documentation issues. Review audit trails for computerized systems (e.g., Empower) to verify data integrity and proper system usage. Basic Qualifications
Bachelor’s degree in a life science field such as Chemistry or Biochemistry. 2–5 years of experience in a pharmaceutical analytical laboratory or quality control environment with laboratory data review responsibilities. Strong knowledge of analytical techniques including HPLC, GC, UV‑Vis, and FTIR. Proficiency with chromatographic data systems such as Empower. Thorough understanding of cGMP, GDP, and data integrity principles. Knowledge of relevant regulatory guidelines (FDA, ICH). Preferred experience with medical device testing. Exceptional attention to detail and strong written and verbal communication skills. Effective organizational and time‑management skills to handle multiple priorities. Ability to work independently and collaboratively. Physical Demands
Regular use of hands to handle materials and supplies. Extensive computer use and electronic communication. Regular standing and walking for extended periods. Occasional lifting or moving up to 20 pounds. Following proper PPE and site safety procedures. MEC does not accept unsolicited resumes from search firms or staffing agencies. All unsolicited resumes are considered the property of MEC and no placement fees will be paid. Reasonable accommodations may be made for individuals with disabilities. MEC is an equal opportunity employer. AAP/EEO DFWP.
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