Quality Assurance Lead
Bethesda Metro Area, Maryland
This individual will be responsible for ensuring the safety, efficacy, purity, and quality of manufactured products through compliance with cGMPs, regulations and established procedures. They support the review of batch records (including aseptic process simulation batch records), assemble and review batch files, support the completion of the annual product review, maintain and utilize Quality Assurance databases, utilize the SAP System, review documentation for compliance with cGMPs, FDA, ICH and other regulatory requirements and perform administrative tasks. Second shift work will be required.
Investigational writing / reviewing
Attention to detail
Communication skills: verbal and written
Data collection, management, and analysis
Problem analysis and problem solving
Risk-based GMP decision-making
Strong computer skills, including Microsoft Office and databases
Minimum of a bachelor's degree in Biology, Chemistry, Microbiology, or related field
Experience in quality inspection, auditing, and testing
Experiance with implementation of corrective / preventive action programs.
Product or industry experience
Knowledge of tools, concepts, and methodologies of QA
Knowledge of relevant regulatory requirements