Scientist, Quality Control Analytical Data Reviewer
GENERAL SUMMARY (FUNDAMENTAL PURPOSE OF THE POSITION)
This Quality Control Scientist, Analytical Data Reviewer is a subject matter expert on review of documentation associated with the operation of a cGMP QC laboratory. Responsibilities include the application of uniform practices for review of analytical raw data and electronic data in the analytical laboratory supporting batch release, stability, cleaning verification, raw materials release, method qualification and method transfer activities. Routine inspection of laboratory documentation for compliance with current industry standards is also within scope.
ESSENTIAL JOB FUNCTIONS* (PRIMARY RESPONSIBILITIES)
• Reviews cGMP microbiology data generated during testing to support product release, stability and facilities monitoring using HPLC, UPLC, Capillary Electrophoresis and wet chemistry methods. Ensures that standards for documentation and comply with SOPs (analytical methods and Good Documentation Practices) and industry standards.
• Strong technical knowledge including an understanding of laboratory procedures, methodology and standards. A minimum of three years of QC analytical laboratory experience is preferred.
• Review laboratory logbooks, labeling and other documentation to ensure conformations with SOPs and industry guidelines. Provides technical support for monitoring and evaluating the performance of analytical methods to demonstrate ongoing method suitability.
• Compile and summarize analytical raw data in various physical and electronic report formats.
• Reviews protocols, analytical reports and certificates of analysis.
• Provides guidance and training to QC personnel to support company training in the procedures used to effectively execute testing.
• Participates in compliance-focused teams working towards the goal of continuous improvement of laboratory documentation practices.
• May coordinate and track progress of analytical testing internally or at CROs.
• May participate in regulatory agency audits and inspections
CORE COMPETENCIES (KNOWLEDGE, SKILLS, AND ABILITIES)
• Thorough knowledge of SOPs and Federal Regulations to include GLP and GMP.
• Familiarity with regulatory guidance documents from FDA, EMEA and ICH.
• Ability to operate independently where appropriate, yet escalate issues as appropriate, establish effective cross functional working relationships.
• Strong attention to detail is essential. Well-developed organizational, interpersonal communications, writing, and strong listening skills are required.
• Must have ability to prioritize and manage multiple, concurrent projects with often long-life cycles.
• Must be able to recognize the impact beyond a single site, project or collaboration.
• Must have strong verbal, technical writing and presentation skills.
EDUCATION/ EXPERIENCE (MUST INCLUDE MINIMUM REQUIREMENTS NECESSARY TO PERFORM ESSENTIAL JOB FUNCTIONS; ADDITIONAL PREFERENCES OPTIONAL)
• M.S. degree in Biochemistry, Molecular Biology or a related field, and three (3) years relevant experience or B.S. degree and five (5) years of relevant GMP lab experience with biotherapeutics. Experience in a regulated biopharmaceutical environment with analysis of biological molecules is preferred.
• Three to five years of experience testing pharmaceutical products in a GMP-regulated QC laboratory. Experience with HPLC / UPLC, spectrophotometers, and capillary electrophoresis is preferred.
• Knowledge of QC laboratory test procedures, cGMP requirements, ICH/USFDA guidelines, raw material analysis, method validation guidelines, analytical method transfers, finished products, and stability testing.
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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