QC Analyst 3

Responsibilities

• writes and executes procedures for analytical method protocols, generating reports related to QC method transfer, validation, and verification.
• may write standard operating procedures (SOPs), protocols, and/or participate in instrument qualifications and analytical system validation.
• support monitoring of analytical method performance, including assessment of analytical method system suitability requirements.
• assist with data trending and aid in compilation of trend reports utilizing statistical tools.
• work with internal departments to ensure system lifecycle document readiness and support analytical instrument qualification and system validation.
• present to cross-functional teams and effectively communicate critical analytical issues and solutions.

Qualifications

• Bachelor’s degree or equivalent in Chemistry/Biochemistry, or a related discipline.
• Minimum of 5 years of relevant professional experience, including a combination of Quality Control, Analytical Development, or Microbiology. An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed.
• troubleshoot equipment and analytical testing methods.
• prior experience with analytical method validations.
• excellent technical writing skills.
• thorough understanding of industry testing requirements/standards.
• excellent time management skills; organized and able to meet company deadlines.
• familiar with FDA and EMA guidance documents relevant to gene therapy.
• experience with Analytical Instrument Qualification and System Validation in laboratory environments.
• familiarity with compendial methods including USP and EP.

Pay

TBD

Schedule

N/A

Benefits

N/A