Spray/Particulate Lab - Auditor
Company: Renaissance LLC
Location: Lakewood
Posted on: September 3, 2020
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Job Description:
Renaissance LLCAll 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.
Overview
The Spray Auditor will provide technical support for routine data
integration and reviewing activities of raw materials, finished
product, bulk in-process and component documentation. Identify
basic technical problems, a typical test results or methodology and
assist in the investigation to correct them. Remediate complicated
technical issues related to the collection of data. Other important
duties include ensuring notebooks and reports are in compliance
with regulatory guidelines, completing projects' data review within
time limits, and verifying mathematical calculations, interpreting
results, recording observations and responding to and assisting in
audits and investigations.
Responsibilities
--- Accurately review data using validated test methods and SOPs in
a cGMP environment.
--- Demonstrate technical competence in the data review that is
related analytical data integration. Review methods that is related
to use of instrumentation & data processing to the job including,
but not limited to:
o HPLC High Pressure Liquid Chromatography
o UPLC Ultra High Pressure Liquid Chromatography
o IR Infra-Red Spectroscopy
o Spray Characterization Tests
o Particulate Matter Tests
--- Support regulatory submission information gathering.
--- Identify opportunities to improve processes/systems.
--- Responsible for analyzing data, maintaining accurate and
detailed written records and notebooks and thoroughly reviewing lab
notebooks ensuring compliance to test methods and
specifications.
--- Perform testing within the lab, when necessary.
--- Perform other duties and responsibilities as assigned such as
Trackwise deviation initiation.
Qualifications
Bachelor's degree required. Master's degree preferred. A minimum of
5 years of HPLC or UPLC experience in pharmaceutical industry
required.
Keywords: Renaissance LLC, Lakewood , Spray/Particulate Lab - Auditor, Accounting, Auditing , Lakewood, New Jersey
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