Title: Quality Associate III
Location: Marion, NC
Duration: 6+ Month
Pay Range: $35.00/hr to $40.00/hr on W2
Candidates needed to start ASAPPosition Summary
Subject Matter Expert on qualifications related to Environmental Monitoring program and Contamination Control from the microbiological standpoint. Responsible for completion of room qualifications of controlled manufacturing areas. Responsible for completion of assessments to determine impact on the microbiological conditions related to manufacturing clean rooms.
Job 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
• Interfaces 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
Knowledge, Skills, and Abilities
• Thorough 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
Required Education and Experience
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.
Other Duties as Assigned
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. Overtime is worked as required. •
Last updated on Aug 21, 2023