QC Reagent Associate

Natera•San Carlos, CA

7h•$27 - $34•Onsite

About The Position

Executes the preparation and qualification of molecular diagnostic reagents. 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.

Requirements

BS/BA degree (or equivalent) in Biological Sciences, Biology, Chemistry, or related field
Able to multi-task and work independently in a team environment
Ability to promote a positive team environment
Adaptability 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

Nice To Haves

1+ year of relevant Molecular Biology experience in a laboratory setting is preferred
QC and/or development background is preferred
Experience with writing of SOP’s and QC documentation is preferred

Responsibilities

Perform routine Quality Control tests on new incoming shipments of raw materials and small-scale manufacturing procedures (formulations and dispensing) reagents following the standard methods and procedures typically under supervision
Reviews data obtained for compliance to specifications and reports abnormalities/discrepancies
Receive, verify, label, store reagents according to department procedures
Coordinate labeling and dispensing for reagents following standard operating procedures with little to no errors
Stock laboratory with qualified reagents and consumables as needed
Assist with reagent preparation and qualifications
Verify that data is properly entered into laboratory inventory system
Maintain and update QC Records, QC documentation (raw material specification, reagent qualification, and QC testing), Cleaning and Maintenance Records
Document all corrective actions taken when test systems deviate from the established performance specifications as needed
Meet expected performance metrics within role as applicable
Follows/Ensures GLP (good laboratory practices) and GMP (good manufacturing practices) compliance
Reports Non-Conformity of SOPs to lead/supervisor/manager
Submit Non-Conformance Report (NCR) when applicable
Ensures work is consistently completed in a timely manner
Ensures all dispenses are qualified and accounted for
Assists in training new hires
Assists in training/implementation of new process changes, as needed
Recognizes, escalates, and troubleshoot equipment malfunctions and most processing errors according to the laboratory’s standard operating procedures
Maintains equipment and instruments in good operating condition (such as calibration and expiration date)
Recognizes, documents, and escalates protocol deviations in lab to lead/supervisor/manager
Communicates with team and other departments on various platforms (including via e-mail)
Provides feedback on day-to-day schedule and tasks to lead/supervisor/manager
Assists teammates in completing daily tasks
Assists in planning workflow and day-to-day schedule
Works intra and inter departmentally to provide support and solutions for workflow.
Perform materials, supplies, and equipment tracking and planning in the laboratory for performance of duties
Work cross-functionally with other departments to ensure timelines are met
Dispose of waste in compliance with Safety & Environmental procedures
Able to perform work with minimal supervision
Participate in Continuous Improvement Projects
Escalates issues/team concerns and suggests possible solutions to lead/supervisor/manager
Assist with internal audits and inspection preparation, as needed
Provides guidance and constructive feedback to team members
Offers suggestions/ideas for improvement and assists with developing team’s troubleshooting and judgement skills
Keeps team morale up and maintains professionalism of team members
Maintains clean and organized workspace
Conducts himself/herself in a professional manner
Adheres to Departmental Expectations