QC Analyst I *PC 1445

Your Tasks:

This position is primarily responsible for supporting day-to-day CGT 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. Must be able to work a flexible schedule at a fast pace.

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.
• 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 including flow cytometry analysis, Nucleic Acid Extraction, qPCR, ELISA, under supervision.
• Accurately executes 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. Performs and assists in equipment qualification and method validations with supervision, as needed.
• Participate in continuous improvement projects, as needed, and other duties as assigned.
• May support other functional areas or duties as necessary or assigned.

Requirements:

• Bachelor's Degree in the life sciences or related from a four-year college or university; 0-2 years relevant experience and/or training in a laboratory or cGMP/cGTP environment (clinical, microbiology, hematology, immunology or Quality Control); or equivalent combination of education and experience. (Preferred)
• Working knowledge of quality systems, including but not limited to change controls, deviations, CAPA's, GxP regulations and standards. 
• 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 flow cytometry, qPCR, ELISA and Cell-based assays. 
• Experienced with MS Office (Word, Excel and PowerPoint). 

Physical Therapy:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle, or feel; reach with hands and arms, talk, and hear. The employee is required to stand; climb or balance and stoop, kneel, crouch. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail.

Work Environment: 

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. This job is performed in a temperature-controlled facility without exposure to extreme hot or cold temperatures. Generally, this job is performed in a clean laboratory setting and routinely uses standard medical and research equipment such as centrifuges, biosafety cabinets, microscopes, incubators, pipettes and computers. While performing the duties of this job, the employee is exposed to viruses and bacteria. Employees entering the laboratory must wear appropriate clothing and protective equipment such as lab coats, glasses and gloves. The noise level in the work environment is usually moderate.

Miltenyi Biotec is an EO Employer – M/F/Veteran/Disability/Sexual Orientation/Gender Identity.

Miltenyi Biotec, Inc. participates in E-Verify.

Are you ready to start revolutionizing biomedical research? When you join Miltenyi Biotec, you join a family that is passionate about making a real impact – one breakthrough at a time. One integral division of that Miltenyi Biotec family is Miltenyi Bioindustry — our contract development and manufacturing organization (CDMO). As a full-scale CDMO, we provide customers with services for the development and manufacturing of lentiviral vectors and cell and gene therapy products. This crucial arm of our enterprise bridges the gap between research and mass bioproduction, ensuring that our solutions are accessible on a global scale. Miltenyi Bioindustry plays a unique role as both the producer and the service provider, relying on our instruments and reagents for each workflow step, controlling the entire supply chain and thus delivering greater security and planning clarity to our customers.