Job Description
• Translate technical information and requirements into experimental design.• Generate, review, and execute phase-appropriate method validation/verification/transfer protocols.• Prepare documentation in support of 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. Ensure that SOPs are current.• Assist in the maintenance of validation/verification/transfer documents.• Assist in writing risk analysis (or statistical analysis) as part of validation activities.• Monitor and track 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 follow up once the actions are implemented to ensure their effectiveness.• Work closely with other departments to ensure accurate transfer of methods 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 the Regulatory Department to ensure that information pertinent to method validation is transparent to regulatory.• Offer expertise to other departments such as Production, Maintenance, Quality, Engineering, and Analytical Services.• Plan and coordinate activities required as part of the validation protocol with 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.
Hard SkillsHPLC method developmentGC/gas chromatography method developmentMass spectrometry (MS)Job Type
This is a Contract-to-Hire position with a duration of 6 Month(s).
Work Site
This is a fully on-site position in San Diego, California.
Work Environment
QC Validation Lab
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & InclusionAt Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our peopleThe company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.