POSITION SUMMARY:

Support the activities for reagents used in the Operations Department’s Clinical Laboratories, which includes but is not limited to incoming material inspections to assure product safety and compliance to specifications, GMP’s, and ISO requirements

PRIMARY RESPONSIBILITIES:

• Coordinate labeling and prep for reagents following standard operating procedures with little to no errors

• Receive, verify, label, store reagents according to department procedures

• Responsible for ensuring reagents are stored in appropriate conditions

• Ensures all dispenses are qualified and accounted for

• Verify that data is properly entered into laboratory inventory system

• Stock laboratory with qualified reagents and consumables

• Performs routine incoming inspection and documentation for product release

• Able to perform work with little to no supervision.

• Works intra and inter departmentally to provide support and solutions for workflow

• Communicates with team and other departments on various platforms (including via e-mail)

• Assists teammates in completing daily tasks

• Ensures work is completed in a timely manner

• Work cross-functionally with other departments to ensure timelines are met

• Provides feedback on day-to-day schedule and tasks to lead/supervisor/manager

• Follows/Ensures GLP (good laboratory practices) and GMP (good manufacturing practices) compliance

• Recognizes, documents, and escalates protocol deviations in lab to lead/supervisor/manager

• Reports Non-Conformity of SOPs to supervisor/manager

• Submit Non-Conformance Report (NCR) when applicable

• Document all corrective actions taken when test systems deviate from the established performance specifications

• Maintains clean and organized workspace

• Dispose of waste in compliance with Safety & Environmental procedures

• Keeps team morale up and maintains professionalism of team members

• Offers suggestions/ideas for improvement and assists with developing team’s troubleshooting and judgement skills

• Maintains equipment and instruments in good operating condition (such as calibration and expiration date)

• Recognizes, escalates, and troubleshoot equipment malfunctions and most processing errors according to the laboratory’s standard operating procedures

• Escalates issues and team concerns and suggests possible solutions to supervisor and/or manager

• Provides guidance and constructive feedback to team members

• Meet expected performance metrics within role

• Assist in training/implementation of new process changes

• Assist in planning workflow and day-to-day schedule

• Assist in training new hires

• Assist with internal audits and inspection preparation

• Maintain and update QC Records, QC documentation (raw material specification, reagent qualification, and QC testing), Cleaning and Maintenance Records as needed

• Assist with reagent preparation and qualifications as needed

• Assist with internal audits and inspection preparation as needed

• Compile data and prepares reports as needed

• Participate in Continuous Improvement Projects as needed

Conducts himself/herself in a professional manner

• Adheres 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
• Performs other duties as assigned

QUALIFICATIONS:

• High School Diploma or GED or equivalent

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

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

• Relevant Molecular Biology experience in a laboratory setting is preferred

• Experience with writing of SOP’s and QC documentation is preferred

KNOWLEDGE, SKILLS, AND ABILITIES:

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

• Ability to promote a positive team environment

• Adaptability and Flexibility in a frequently changing environment

• Maintain a high level of professionalism and responsibility

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

• Excellent oral and written communication skills

• 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

• Willingness to learn

• Actively seeks ways to improve quality and workflows

• Strong time management skills

• Punctual and consistent attendance

• Ability to speak, read, and write in English