Technologist III – Qc

Technologist III – Qc

Requirements

• High school diploma required; Bachelor’s degree in Science or equivalent experience preferred.
• A minimum of four (4) years previous Quality Control lab (QC) and/or Quality Assurance (QA) experience required; previous experience within a regulated medical device manufacturing or In-Vitro Diagnostic Device (IVDD) strongly preferred.
• Thorough understanding of Good Laboratory Practices (GLP) required.
• Practical experience with laboratory controls, internal audits, and lab training/maintenance.
• Knowledge of FDA-GMP/QSR and ISO standards for quality.
• Excellent written and verbal communication skills.
• Ability to work independently and as part of a team.
• Proficiency with common laboratory techniques, such as pipetting and use of balances.
• Proficiency with Microsoft Office suite.

Responsibilities

• Perform and organize testing of biological raw materials and finished goods per relevant SOP with minimal supervision; subject matter expertise in at least one product line.
• Assist with planning of method, product and process validations on existing products; perform and organize testing as needed.
• Perform testing and prepare reports as required for environmental monitoring or investigation of out-of-specification results, as required.
• Perform testing and assist with preparation of reports for various special projects as deemed necessary by technical review team.
• Responsible for tracking relevant trends.
• Maintain proper laboratory housekeeping and supply levels in the QC laboratory, including submission of purchase requisitions and inventory adjustments.
• Document all test results and maintain product release records (including electronic records).
• Document existing product/process validation test results (including electronic records).
• Maintain product testing database and perform relevant statistical analyses associated with product specifications as specified in laboratory SOPs.
• As required, coordinate and assist with investigation and resolution of complaints, non-conforming material and product performance issues.
• Submit complex change orders to update procedures as required.
• As required, work cross-functionally to investigate and resolve issues deriving from finish product testing.
• Ensure and maintain compliance with the Company’s quality system requirements through training and adherence to policies, procedures and processes.
• Other duties as assigned.

Preferred Qualifications

• Phlebotomy certification a plus.
• Proficiency with Large Enterprise Resources Planning (ERP) and Laboratory Information Management (LIMS) systems preferred.