QC Reagent Assoc 1

POSITION SUMMARY:

Support the activities for reagents used in the Operations Department’s Clinical Laboratories. Executes the preparation and qualification of molecular diagnostic reagents. Performs Quality Control tests on new incoming shipments of raw materials and small-scale manufacturing procedures (formulations and dispensing) reagent. Reviews data obtained for compliance to specifications and reports abnormalities. Maintains and improves QC documentation pertaining to raw material specification, reagent qualification, and QC testing. Support Incoming Quality Control activities as needed.

PRIMARY RESPONSIBILITIES:

• Perform incoming inspection and reagent release: Receive, verify, label, store reagents according to department procedures • Coordinate labeling and prep for reagents following standard operating procedures

• Perform routine Quality Control tests on new incoming shipments of raw materials and manufacturing procedures (formulations and dispensing) reagents following the standard methods and procedures

• Recognize and escalate equipment malfunctions/processing errors according to the laboratory’s standard operating procedures

• Optimize QC workflows by providing suggestions/ideas for improvement

• Escalate issues/concerns and suggest possible solutions• Support QC documentation updates• Work intra- and inter-departmentally to support workflows• Work cross-functionally with Team and other departments on various platforms

• Follow/Ensure GLP (good laboratory practices) and GMP (good manufacturing practices) compliance

• Escalates Non-Conformity

• Conduct self in a professional manner

• Able to perform work with minimal supervision

• Perform other duties as assigned• Adhere to Departmental Expectations

• This role works with PHI on a regular basis both in paper and electronic form and have access to various technologies to access PHI (paper and electronic) in order to perform the job• Employee must complete training relating to HIPAA/PHI privacy, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire• Must maintain a current status on Natera training requirements

• Employee must pass post offer criminal background check

QUALIFICATIONS:

• BS/BA degree (or equivalent) in Biological Sciences, Biology, Chemistry or a related field

• 1+ years of QC experience or equivalent in a Clinical laboratory environment is preferred

• Relevant Molecular Biology and/or Cell Culture experience in a laboratory setting is strongly preferred

KNOWLEDGE, SKILLS, AND ABILITIES:

• Adaptability and Flexibility in a frequently changing environment

• Able to multi-task and work independently in a fast-paced Team environment

• Excellent interpersonal, communication, computer (MS word, Excel, PowerPoint, etc.), troubleshooting, organizational, problem-solving, and technical skills

• Strong time management skills

• Actively seeks ways to improve quality and workflows

• Willingness to learn

• Ability to promote a positive Team environment

• Maintain a high level of professionalism and responsibility

• Basic knowledge in Data management, Google Docs, LIMS, and Continuous Improvement

• Takes initiative and ownership of projects/assignments with attention to detail

• Accepts and incorporates feedback

• Punctual and consistent attendance

• Ability to speak, read, and write in English

PHYSICAL DEMANDS & WORK ENVIRONMENT:

• Must be able to lift up to 50lbs and perform laborious tasks

• Standing or sitting for long periods of time may be necessary

• Duties require exposure to cold air due to frequent accessing of refrigeration/freezer units

• This position requires the ability to use a computer keyboard, handheld scanning device, communicate via electronics, read materials, and use equipment in reagent preparation

• Duties are performed in a laboratory setting (ie. BSL-1, BSL-2, etc.) with potentially hazardous material and in an office se