Reagent QC Associate I

Essential Duties and Responsibilities

• Captures and submits manufacturing QC data and batch records for QA review and approval
• Maintains records and clean room environment to comply with good manufacturing practices and standard operating procedures
• Aids in inventory management and material ordering
• Aids in the development of reagent manufacturing QC processes and documentation
• Aids in maintaining production and laboratory equipment
• Aids in the development of physical quality specifications and tests
• Aids in testing raw materials for reliability and stability
• May assist in process scaleup to transition from pilot lots to full productionscale manufacturing
• Complies with ISO 13485 and cGMP standards
• Supports continuous quality improvement

Qualifications

• Proven ability to deliver productivity to plan
• Excellent communication skills (listening, written, verbal, presentation)
• Strong technical skills, including a working understanding of molecular biology and biochemistry
• Demonstrated analytical, troubleshooting, and problem-solving skills
• Proven math skills
• Experience with Microsoft Word and Excel
• Demonstrated attention to detail
• Strong written and verbal communication skills
• Proven ability to meet deadlines and work under aggressive timelines
• Accurate and precise manual pipetting and measuring techniques
• Experience working with automated dispensing equipment is preferred, but not required

Education and Experience

• BS in molecular biology or related field with at least 2 years of hands-on experience in reagents manufacturing
• Master’s degree in one of the related fields is preferred

Language Skills

• Must be proficient in writing and communicating in the English language including presentation of data and results
• Computer literate with a working knowledge of Microsoft Word and Excel

Mathematical Skills

• Must be consistent with level education

Reasoning Ability

• Good problem solving, judgment and decision-making skill are required
• High degree of organizing skill, planning skill, prioritization skill
• Multitasking ability

Physical Demands

• Regularly performs tasks while working at a computer, desk, laboratory bench or automated machine
• Occasional lifting and/or moving up to 25 pounds
• Occasionally requires travel between buildings

Work Environment

• The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job
• This position will involve a combination of office and biotechnology laboratory environments
• While performing the duties of this job, the employee may be exposed to hazardous chemicals, blood-borne pathogens, automated equipment, and high levels of noise and vibration