QC EM Analyst II (Monday - Friday 8:30AM - 5:00PM) PC 641
About The Position
Your Role: This position is primarily responsible for coordinating and conducting day-to-day Quality Control activities for in-process and final product release testing including GMP release testing and execution of Quality Control Method Development with minimal to no supervision. This role may also be responsible for performing all GMP activities to support client and internal company projects while following applicable SOPs with precision and accuracy and demonstrating a high level of documentation accuracy and clarity. Essential Duties and Responsibilities: Facilitate, coordinate, and conduct tasks (i.e. setting schedules to ensure timely completion of Tissue Culture / Transduction; Nucleic Acid Extraction; qPCR; ELISA; SDS-PAGE; Restriction Digests; and Agarose Gels). Execute QC release, in-process and stability testing of raw materials, in-process and final products with flexible schedule. Strictly follows test procedures and SOPs. Support and participate in development of QC methods and procedures. Responsible for the accuracy and validity of testing results. Maintain accurate and complete records per cGMP. Supports assay optimization and qualification. Partner and collaborate with Quality to address QC assay issues. Support assay execution and training in areas where qualified. May assist with equipment qualification and validation activities. May support other functional areas or duties as necessary or assigned. Shift: Monday - Friday 8:30AM - 5:00PM
Requirements
- Bachelor’s degree in the life sciences or related from a four-year college or university with a minimum of 2 years relevant experience and/or training in a laboratory or cGMP/cGTP environment (clinical, microbiology, hematology, immunology or Quality Control)
- Working knowledge of quality systems, including but not limited to change controls, deviations, CAPA's, GxP regulations and standards
- Hands on experience with biopharmaceutical Quality Control, flow cytometry and proactively managing laboratory materials
- Demonstrated ability to effectively communicate with cross functional groups
- Experienced and knowledgeable in laboratory techniques including pH, Osmolality, qPCR, ELISA and Cell-based assays
- Experienced with MS Office (Word, Excel and PowerPoint)
- Proficient in QC test methods/procedures and use of the QC lab equipment
- Proficient in Flow Cytometry, qPCR, ELISA, and cell-based assays
Responsibilities
- Facilitate, coordinate, and conduct tasks (i.e. setting schedules to ensure timely completion of Tissue Culture / Transduction; Nucleic Acid Extraction; qPCR; ELISA; SDS-PAGE; Restriction Digests; and Agarose Gels)
- Execute QC release, in-process and stability testing of raw materials, in-process and final products with flexible schedule
- Strictly follows test procedures and SOPs
- Support and participate in development of QC methods and procedures
- Responsible for the accuracy and validity of testing results
- Maintain accurate and complete records per cGMP
- Supports assay optimization and qualification
- Partner and collaborate with Quality to address QC assay issues
- Support assay execution and training in areas where qualified
- May assist with equipment qualification and validation activities
- May support other functional areas or duties as necessary or assigned
Benefits
- health, vision, and dental insurance
- 401(k) plan
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
501-1,000 employees
