Analytical Validation Chemist
Company: nxtgen search
Location: Torrance
Posted on: June 21, 2022
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Job Description:
Overview:
- 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
Requirements:
--- BSc. in Biotechnology, Chemistry, Pharmacy, Chemical
Engineering or Pharmaceutical Technology. Desirable MSc in the
above or equivalent--- Minimum of 2 years in Pharmaceutical,
Biological or Biotech industry; hands-on experience in
pharmaceutical validations, or extensive laboratory experience in
wet chemistry/microbiology highly desired.---Thorough experience in
computerized systems, data management, process control and
fundamental understanding of applied statistics (MS-office,
etc.).--- Fluent in English
Keywords: nxtgen search, Torrance , Analytical Validation Chemist, Other , Torrance, California
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