QC Analyst II *PC 1446

Your Tasks: 

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

Essential Duties and Responsibilities:

• Facilitate, coordinate, and conduct tasks (i.e. setting schedules to ensure timely completion of flow cytometry analysis, Nucleic Acid Extraction, qPCR, ELISA)
• 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.

Requirements: 

• Bachelor's Degree in the life sciences or related from a four-year college or university; A minimum of 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. (Required)
• Working knowledge of quality systems, including but not limited to, change controls, deviations, CAPA's, GxP regulations and standards. 
• Hand on experience with biopharmaceutical Quality Control, flow cytometry and proactively managing laboratory materials. 
• Demonstrated ability to effectively communicate with cross functional groups. Required
• Experienced and knowledgeable in laboratory techniques including pH, Osmolality, qPCR, ELISA and Cell-based assays. (Required)
• Experienced with MS Office (Word, Excel and PowerPoint). 

Physical Demands:

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.