QC Reagent Assoc 1

POSITION SUMMARY:

Executes the preparation and qualification of molecular diagnostic reagents.

PRIMARY RESPONSIBILITIES:

• Maintain cell lines needed for reagent production and testing. Ensure that cultures remain uncontaminated, properly curated, and maintained according to best practices.

• Maintain and improve documentation pertaining to raw material specifications, cell line maintenance, reagent qualification, and QC testing.

• 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

• 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

• Performs other duties as assigned

QUALIFICATIONS:

• 1+ year of relevant Molecular Biology experience in a laboratory setting is preferred

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

• QC and/or development background 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 team environment

• Ability to promote a positive team environment

• Adaptability in a frequently changing environment

• Maintain a high level of professionalism a