What are the responsibilities and job description for the Quality Control Analyst - Bioassay and Virology (Contract) position at CEDENT?
About the job:
The QC Analyst – Bioassay & Virology contractor will be responsible for routine and non-routine QC testing according to Standard Operating Procedures (SOPs). This contract position is based at Client’s new state-of-the-art facility in Lexington, MA. This role will support the execution of analytical testing, bioassay testing and Quality Systems. This includes but is not limited to in-process testing, lot release testing, and stability testing. Execution of quality systems entails deviations, corrective and preventive actions (CAPAs), investigations, Out of Specifications (OOS), and change controls. These activities are all performed in accordance with cGMP guidelines and are supported by departmental and inter-departmental policies and standard operating procedures.
The QC Analyst – Bioassay & Virology contractor will be responsible for routine and non-routine QC testing according to Standard Operating Procedures (SOPs). This contract position is based at Client’s new state-of-the-art facility in Lexington, MA. This role will support the execution of analytical testing, bioassay testing and Quality Systems. This includes but is not limited to in-process testing, lot release testing, and stability testing. Execution of quality systems entails deviations, corrective and preventive actions (CAPAs), investigations, Out of Specifications (OOS), and change controls. These activities are all performed in accordance with cGMP guidelines and are supported by departmental and inter-departmental policies and standard operating procedures.
- Cell culture experience using various cell lines such as Huh-7, HeLaRC32, HEK293 and SF9/SF
- Perform routine/non-routine testing and review of in-process, DS and DP release and stability samples in accordance with Standard Operating Procedures (q-PCR, Potency Assay, TCID50 and other Cell based assays)
- Performs peer review as SME of assay data with minimal errors.
- Able to work effectively in internal/cross-functional teams as an active member. Train and execute on assays cross-functionally to support deadlines for release.
- Participate in equipment validation, method transfer/validation, and special protocol execution
- Establish, revise, review and maintain standard operating procedures Responsible for Quality Systems related to QC Operations such as identifying a deviation to procedure, perform an investigation, Change Controls, CAPAs, OOSs, OOTs.
- Responsible for protocol and report generation/revision/review, as required.
- Strong understanding of regulations, able to apply to any situation, and identify deficiencies w/ some guidance.
- Promptly and proactively communicates gaps to key stakeholders and recommends solution w/minimal guidance.
- Supports internal and external audits as required.
- BA or BS in Cell Biology, Molecular Biology or other related science
- Minimum 6-10 years of laboratory base experience within QC testing capacity, preferably in cGMP environment.
- High proficiency in mammalian and insect cell culture.
- Follow procedures trained on and complete documentation applying cGMP/GDP/ALCOA .
- Thorough understanding of industry testing requirements/standards.
- Computer literacy (MS Word, Excel, and LIMS)
- Good/effective communication and organizational skills with the ability to work well with others and independently.
