Entry Level Quality Control Analyst
Company: Planet Pharma
Posted on: May 16, 2022
*Shift note- Shifts available: (M-TH or T-F; starrting at
The QC Analyst is an entry level role and is responsible for
providing support to the on-time release, stability and non-routine
testing of the pharmaceutical drug substances and drug product in a
cGMP environment. The QC Analyst is responsible for providing
support to activities related to sample and/or lab equipment
management. The QC Analyst is responsible for supporting analytical
method development, assisting with troubleshooting work and
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. Key Responsibilities
- 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, 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
- Develop, optimize, validate and troubleshoot analytical test
- 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
- Support sample and record management for testing within the
group and at CRO/CTO's
- Manage shipment of materials and samples to other company
sites, CRO/CTO's, or to in-country testing labs
- Interact directly with regulatory agency inspectors during
- Interface with other departments (Manufacturing, Quality
Assurance, Facilities, etc.) and contractors as necessary
- Other duties as assigned
Keywords: Planet Pharma, Novato , Entry Level Quality Control Analyst, Professions , Novato, California
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