Quality Lab Associate III – Sterility Assurance

Quality Lab Associate III – Sterility Assurance

Requirements

• BS degree in Biology or Microbiology.
• Five (5) or more years of professional experience in Laboratory, Quality, Manufacturing, or related field is strongly preferred.
• Strong understanding of Environmental Monitoring programs, Microbiology concepts and Good Documentation practices is preferred.
• Detailed knowledge of applicable procedures, specifications, regulations, and standards.
• Strong analytical and problem-solving skills.
• Ability to manage multiple projects/investigations/priorities.
• Good communication and leadership skills.
• Good interpersonal/communication/influencing/negotiation skills.
• Good project management skills.
• Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawings.
• Strong technical written skills.
• Knowledge of TrackWise Quality Management System.

Responsibilities

• Author and complete Environmental Monitoring Performance Qualifications (EMPQ) related to the manufacturing clean/classified rooms in compliance with local and regulatory requirements.
• Coordinate sampling activities with EM sampling team and manufacturing department as applicable.
• Perform Failure Modes and Effects Analysis, as needed.
• Prepare and present to management the trend reports related to EMPQ and contamination control activities.
• SME of EMPQ and contamination control aspects providing leadership, technical and quality support to manufacturing and during regulatory inspections or site audits.
• Understands and assures conformance to regulations.
• Works with regulators during regulatory inspections.
• Interacts frequently with functional peer group and managers, as appropriate.
• Identifies and manages continuous improvement projects with the objective of achieving quality, reliability, and cost improvements.
• Sustain a clean and safe work area using 6S principles.
• Learn, understand, and apply rigorous quality standards, Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP). Author and revise Standard Operating Procedures as needed.
• Review and approve EMPQ and contamination control procedures, protocols, and reports.
• Perform Sterility Assurance Assessments as part of the Change Control Management process.
• Assist in establishing response plans to environmental out of limits.
• May be asked to lead classroom-based training for new employees and continuous education classes for established employees.

Preferred Qualifications

• Strong understanding of Environmental Monitoring programs, Microbiology concepts and Good Documentation practices is preferred.