QC Analyst I (Swing Shift -1:00pm-9:30pm) PC 637

Miltenyi Biotec•San Jose, CA

13d•$32 - $37•Onsite

About The Position

Your Role: This position is primarily responsible for supporting day-to-day Quality Control activities which may include but is not limited to GMP activities, Assay Development, or supporting client and/or internal company projects while following applicable SOPs. Essential Duties and Responsibilities: Work on diverse client projects with different test methods and analysis of data. Communicate and collaborate effectively with colleagues, management and departments (i.e. Quality and Manufacturing). May act as a point person for client QC assays. Support execution of Quality Control Method Development and GMP release testing (i.e. molecular biology, immunology and tissue culture assays). Conduct routine and non-routine testing while compiling accurate and valid results. Maintain inventory of QC materials and lab supplies, including monitoring and ordering. Assist with developing methods and procedures for Quality Control. Perform timely completion of QC test methods flow cytometry analysis, Nucleic Acid Extraction, qPCR, ELISA, SDS-PAGE, Restriction Digests and Agarose Gels, cytotoxicity assay, under supervision. Accurately execute project test methods and procedures following defined SOPs and compliance practices (GDP, GMP,GTP). Maintain, monitor, and troubleshoot pertinent equipment, performing testing under supervision when needed. Perform and assist in equipment qualification and method validations with supervision, as needed. Participate in continuous improvement projects, as needed, and other duties as assigned.

Requirements

Bachelor’s degree in the life sciences or related from a four-year college or university with 0-2 years relevant experience and/or training in a laboratory or a 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.
Must have hands on experience in flow cytometry and working in biopharmaceutical Quality Control.
Experience fulfilling material needs and supplies for a laboratory and effectively communicating cross functionally.
Knowledge and experience with 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

Work on diverse client projects with different test methods and analysis of data.
Communicate and collaborate effectively with colleagues, management and departments (i.e. Quality and Manufacturing).
May act as a point person for client QC assays.
Support execution of Quality Control Method Development and GMP release testing (i.e. molecular biology, immunology and tissue culture assays).
Conduct routine and non-routine testing while compiling accurate and valid results.
Maintain inventory of QC materials and lab supplies, including monitoring and ordering.
Assist with developing methods and procedures for Quality Control.
Perform timely completion of QC test methods flow cytometry analysis, Nucleic Acid Extraction, qPCR, ELISA, SDS-PAGE, Restriction Digests and Agarose Gels, cytotoxicity assay, under supervision.
Accurately execute project test methods and procedures following defined SOPs and compliance practices (GDP, GMP,GTP).
Maintain, monitor, and troubleshoot pertinent equipment, performing testing under supervision when needed.
Perform and assist in equipment qualification and method validations with supervision, as needed.
Participate in continuous improvement projects, as needed, and other duties as assigned.