Senior QC Analyst, Flow Cytometry and Molecular
About The Position
Sr. QC Analyst, Flow Cytometry & Molecular Team, will be executing analytical method transfers to Quality Control, optimize and troubleshoot assays for improvement. He/she will be responsible for authoring protocols, authoring Standard Operating Procedures (SOPs) and Test Methods. He/she will be executing various quality control methods, analyzing data, and reporting data. He/she will assist in the implementation of new assay methodologies and the associated instrumentation. Identifies and supports initiation and completion of deviations, corrective and preventative actions, and laboratory investigations in compliance with all applicable quality systems and current cGMPs. This position is highly visible in the organization and requires the ability to interface with multiple groups, and the ability to assess method suitability, interpret results, perform tasks independently, and troubleshoot.
Requirements
- Bachelor's Degree in scientific discipline.
- 4+ years of relevant experience in cGMP Quality Control Laboratory.
- Hands-on experience with various analytical techniques such as flow cytometry, qPCR, dPCR, ELISAs,cell-based assays, and scientific knowledge in the characterization and transfer of analytical methods.
- Knowledge of cGMP/ICH/FDA regulations.
- Ability to independently prioritize/manage activities.
- Ability to prioritize objectives from multiple projects and adhere to scheduled timelines while maintaining flexibility and attention to detail.
- Proficient in MS Office applications and information technologies that support documentation and data management systems.
- Strong troubleshooting, problem-solving skills, oral and written skills.
- Ability to multi-task and interact with multiple groups in a team-oriented environment.
Nice To Haves
- Experience with rapid microbiological methods is a plus (e.g. mycoplasma)
Responsibilities
- Perform routine and non-routine quality control testing on in-process samples and finished products.
- Operate and maintain laboratory equipment and instruments, ensuring proper calibration and adherence to cGMP Compliance.
- Provide support for method feasibility/transfers/qualification/validation and stability testing.
- Support analytical equipment installation and qualification
- Apply technical knowledge and abilities to ensure all testing is performed in a compliant manner.
- Review all data in accordance with applicable procedures and cGMP requirements.
- Author, review, and/or approve Protocols, SOPs, Test Methods, and other procedures required to operate a QC laboratory.
- Participate in internal and external audits, inspections, investigations, change controls and CAPAs
- Contribute to continuous improvement initiatives, identifying opportunities for efficiency gains and process optimization within the quality control function.
- Anticipate and troubleshoot problems. Communicate effectively with management regarding task completion, roadblocks, and needs.
- Become a qualified trainer on assigned assays and deliver training to analysts, documenting training per procedural and cGMP requirements.
- Provide support to QC Analytical Subject Matter Expert in Flow Cytometry.
- Work independently in a high-paced team environment, meet deadlines, and prioritize work from multiple projects.
- Communicate effectively with cross-functional peers, and department management.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
251-500 employees
