Sr. Analyst, QC
Company: Careerbuilder-US
Location: Novato
Posted on: January 16, 2023
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Job Description:
The QC Analytical Technologies Senior Analyst role is
responsible for laboratory work in support of studies throughout
the lifecycles of pharmaceutical drug substances and drug products
in a cGMP environment. The role is responsible for providing
support to activities related to sample and/or lab equipment
management, ordering supplies and maintaining inventory. This role
is responsible for supporting analytical method development,
assisting with troubleshooting work, executing validation and
transfer protocols, supporting the writing and reviewing of
protocols and reports, supporting training to site QC, Contract
Test Labs, and In Country Testing Labs in new techniques and
methods and when necessary providing support in the preparation of
regulatory submission documents. This role may include overtime and
shift work. Job title may be flexible dependent on candidate's
experience.
--- Adhere and follow cGMPs guidelines and procedures. Escalate
non-compliance concerns to management.
--- Monitor lab equipment for Calibration needs, monitoring and
tracking of issues related to instrumentation.
--- Support the scheduled testing by ensuring the required reagents
and glassware are stocked appropriately.
--- Maintain the laboratory in an inspection-ready state
--- Perform Analytical testing incl: HPLC/UPLC, capillary
electrophoresis, cIEF, SDS Gels, UV Spectrophotometry, plate-based
assays including ELISAs and cell-based Bioassays, PCR, etc.
--- Testing of in-process samples, finished product, non-routine
samples, packaging and stability, etc. in a cGMP environment.
--- Assist with preparation of protocols, summaries, and
reports-often for direct submission to pharmaceutical regulatory
agencies
--- Assist with development, optimization, validation and
troubleshooting of analytical test methods
--- Act as technical resource (SME) and train other analysts in
areas of expertise
--- Evaluate results against defined acceptance criteria
--- Conduct and document laboratory investigations and deviations
to completion
--- Support sample and record management for testing within the
group and at CRO/CTO's
--- Manage shipment of materials and samples to other client sites,
CRO/CTO's, or to in-country testing labs
--- Interact directly with regulatory agency inspectors during
audits
--- Interface with other client departments (Manufacturing, Quality
Assurance, Facilities, etc.) and contractors as necessary
--- Other duties as assigned
Keywords: Careerbuilder-US, Novato , Sr. Analyst, QC, Professions , Novato, California
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