Quality Assurance Data Review Scientist

Responsibilities

• Reviews chromatographic/other data and related notebooks as specified by Standard Operating Procedures (SOPs).
• Evaluates data to ensure compliance with analytical methods, client criteria, SOPs, and Good Manufacturing Practices (GMP).
• Must be able to understand analytical data (chromatographic and other) and scrutinize routine and non-routine testing results to ensure compliance, accuracy, and completeness of work based on documented data.
• Must be able to critically and in detailed fashion review/verify Reports, SOPs, Specifications, Analytical procedures, etc.
• Example: Reviews sample results tables and analytical reports for completeness and accurate representation of the data and report findings.
• Must be able to solve practical problems and deal with a variety of concrete variables in situations where limited standardization exists.
• Must be able to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
• Organizes workflow and tasks to maximize efficiency (e.g., prioritize review/writing based on client/business needs, etc.).
• Demonstrated ability to work with others at all levels of the organization and have basic knowledge of computers and industry-related software.
• Able to work effectively under pressure to meet deadlines.
• Ensures compliance with company policies and SOPs as well as FDA and other applicable guidelines.

Qualifications/Skills

• Fundamental understanding (experience is not required) with the following analytical technologies: Titrations (manual and automated), Basic wet chemistry, FTIR, NMR, XRPD, DSDS, CHPLC, GCMS.
• Working knowledge of other analytical equipment common to the pharmaceutical industry.
• BS or MS in Chemistry (or closely related discipline).
• Relevant background in GXP/QC-compliant pharmaceutical laboratory environment.
• Excellent verbal and written communication and interpersonal skills, problem-solving, and organizational skills.
• Demonstrated ability to work in a diverse team environment.
• Proficiency with Microsoft software (Word, Excel and PowerPoint).