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

Salary: $30-$41 per hour

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.