Duties and Responsibilities:

• Execute feasibility (pre-validation) studies to support validation experimental design
• Translate technical information and requirements into experimental design
• Generate, review and execute phrase appropriate method validation/verification/transfer protocols
• Prepare documentation in support of the sampling, analysis, and reporting of method qualification or validation results
• Perform troubleshooting during method qualification or validation.
• Perform data analysis, interpretation and review using statistical methods
• Prepare summaries and reports
• Compile and track undesirable/unacceptable problems encountered during analytical method execution
• Write, review and assist in the evaluation of the effectiveness of SOPs and identify necessary changes following validation activities. Ensures that SOPs are current
• Assist in the maintenance of validation/verification/transfer documents
• Assist to write risk analysis (or statistical analysis) as part of validation activities;
• Monitoring and tracking of validation/verification/transfer activities
• May assist with training, competency assessment, and performance evaluations of laboratory personnel as appropriate
• Investigate deviations in validation protocols, identify the root cause of the deviation, issue corrective and preventive actions, and carry out follow-up once the actions are implemented to ensure their effectiveness;
• Work closely with AD to ensure accurate transfer of methods from AD to QC.
• Work closely with QC to ensure accurate scheduling of instrumentation and validation activities
• Work closely with QA to ensure documents are reviewed and approved in a timely manner
• Work closely with Project Management and the Account Manager to ensure that customer expectations with respect to method validation and transfers are met
• Work closely with Regulatory Department to ensure that information is pertinent to method validation are transparent to regulatory
• Offer expertise to other departments of the company such as Production, Maintenance, Quality, Engineering and Analytical Services;
• Plan and coordinate the activities required as part of the validation protocol with the departments of Production, Maintenance, Quality, Engineering and Stability;
• Responsible for continuous evaluation/ optimization of test methods for efficiency and cost reduction
• Perform other duties as assigned

Qualifications:

• BS or MS in Analytical Chemistry or equivalent
• 2 years experience in a cGMP pharmaceutical/biotechnology laboratory
• Strong technical knowledge HPLC, GC and MS
• Proficient use of Microsoft Office suite of applications (Outlook, Excel, Word, PowerPoint, Teams, etc.)
• Ability to work as part of a team and also independently with minimal to no supervision
• Ability to rapidly change focus during times of shifting or changing priorities
• Impeccable technical writing skills with extreme attention to detail, specifically the lexicology and grammatology of written English text as applied to technical writing
• Excellent organizational, multitasking, and communication skills