PDS Tech Inc QC Chemist I in Pleasanton, California
PDS Tech, Inc. is seeking QC Chemist I
Responsible to perform activities necessary to maintain and operate the Specialty Chemical QC laboratory during assigned shift. Responsible to carry out technical tasks and support production operations; perform routine and non-routine chemical testing of raw materials, bulk products, finished goods, and validation samples; and evaluate and implement chemical analysis procedures. The QC Chemist will be responsible for ensuring that samples are collected, tested, and reviewed according to quality requirements, and results reported are valid, accurate, and documented per applicable regulatory and corporate requirements. QC Chemist may be required to perform or participate in tasks associated with method validation and transfers.
Performs HPLC, UPLC, GC, NMR, Mass Spec and other chemical testing for QC samples of raw materials, bulk products, finished goods, and validation samples using approved procedures.
Resolve problems with instruments, test methods, lab chemicals, and samples with direct support from Management.
Assure calibrations, standards, logbooks and other compliance activities are performed in the laboratory.
Independently write experiment summaries, laboratory investigations, technical reports, operation and test method procedure documents, and review documents comprising, but not limited standard operating procedures, standard test methods, validation protocols and reports.
Ensure adherence to highest quality and efficiency standards in laboratory operations, foster morale and teamwork.
Complies with policies and procedures in order to maintain compliance with legal regulations, health and safety, and regulatory requirements as written.
Participates in lean lab operation, 5S laboratory layout, preventive action & continuous improvement programs.
Participates and performs in cross-training to support staff availability within QC department.
Perform other duties as assigned.
Possess a thorough understanding of laboratory safety requirements and the MSDS system.
Possess a thorough understanding of chemical test methods and chemical instrumentation, preferably some combination of HPLC, GC, UV/VIS, NMR, Mass Spec and intermediate wet chemistry techniques.
Possess effective interpersonal, leadership and organizational skills.
Possess the ability to use personal computers for word processing and data manipulation.
Possess the ability to work on many tasks simultaneously with minimal support from Manager.
Possess the ability to use common sense and good judgment when faced with decisions during testing.
Demonstrated success at writing, revising, and complying with SOPs, protocols/reports, and QC methods.
Education and/or Experience
Bachelors degree (BS) in Analytical Chemistry or a closely related major. Must have 4+ years of chemical laboratory experience.
Strong background in organic chemistry and experience troubleshooting analytical results preferred.
Experience in the isolation and enrichment of product- and process-related impurities required. .
Experience in a biotech environment preferred.
SAP experience preferred.
Method development and method verification/validation experience preferred.
All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.