7904 Analyst, QC I
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.
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 agencies.
Develop, optimize, validate and troubleshoot 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 Company sites, CRO/CTO’s, or to in-country testing labs.
Interact directly with regulatory agency inspectors during audits.
Interface with other departments (Manufacturing, Quality Assurance, Facilities, etc.) and contractors as necessary.
Other duties as assigned.
BS or BA in Molecular Biology, Biology, Analytical Chemistry, or similar scientific background.
Experience working with adherent cell culture, qPCR, dPCR or similar technologies is highly preferred but not required.
PLEASE NOTE: Our client has mandated COVID-19 vaccination for their workforce, all external personnel providing services to our client are required to comply with this requirement.