Job Information
VTI Life Sciences Analytical Method Validation Chemist in Greater Los Angeles Area, California
VTI Life Sciences (VTI) is seeking forward-thinking and ambitious engineers looking to accelerate their career in the pharmaceutical, biotechnology and medical device industries. We offer an opportunity to help support our teams of industry subject matter experts and thought leaders while consulting with some of the biggest companies in the Life Sciences industries.
We are looking for Three (3) Chemists for analytical test method transfer/validation to develop protocols and final reports for a variety of analytical test methods at our client's pharmaceutical facility in the Greater Los Angeles area.
Duties and Responsibilities:
Generate, review and execute phrase appropriate method validation/verification/transfer protocols
Translate technical information and requirements into experimental design
Prepare documentation in support of the sampling, analysis, and reporting of method validation results
Perform troubleshooting during method validation and transfer
Perform data analysis, interpretation and review using statistical methods
Prepare summaries and reports
Author, compile and track deviations or issues encountered during analytical method validations or transfers
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 to write risk analysis (or statistical analysis) as part of validation activities;
Monitoring and tracking of validation/verification/transfer activities
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 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
Perform other duties as assigned
Qualifications:
BS or MS in Analytical Chemistry or equivalent
3+ years experience in a cGMP pharmaceutical/biotechnology laboratory
Strong technical knowledge KF titrators, HPLC, and protein analysis (Coomassie Stain, Western Blots), etc.
Strong working knowledge of analytical instruments/software and analytical validation and method transfer principles
Proficient use of Microsoft Office suite of applications (Outlook, Excel, Word, PowerPoint, Teams, etc.)
KNEAT Validation Management System experience preferred
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
Excellent organizational, multitasking, and communication skills
SALARY RANGE FOR THIS ROLE IS $80,000 - $115,000 ANNUALLY FOR A W2 EMPLOYEE
VTI Life Sciences strives to maintain and inspire professional excellence by providing Commissioning, Qualification, Quality Engineering, Automation and Validation Services to the Pharmaceutical, Biotechnology, Biologics and Medical Device industries. VTI offers professional development, training, competitive compensation, excellent benefits, matching 401K plus a stimulating and collaborative work environment. We are committed to providing exciting career opportunities in a work environment that values trust, respect, openness, teamwork, creative talent, enthusiasm and diligence.
As one of the leading global Commissioning, Qualification and Validation Services organizations, VTI is always looking for innovative, talented and experienced validation professionals for our multinational and global offices. We offer some of the best salary and benefit packages in the industry for our full-time/permanent employees. www.validation.org
Powered by JazzHR