Quality Associate III
Our Client, one of the Largest Healthcare Corporation Company in the US is looking for a Quality Associate III onsite in Marion, NC (North Cove).
Job Title:
Quality Associate III Location:
100% onsite in Marion, NC (North Cove) Duration:
6 months with the possibility of extension/conversion Hours:
Standard business hours Position 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.
Why Work for Us Here at Experis, We care about people and the role of work in their lives.
We respect people as individuals, trusting them, supporting them, and enabling them to achieve their aims in work and in life.
We have been recognized in multiple ways for our ability to do this successfully.
if you are interested in working with us and learning more about this opportunity, Click the apply button now and start the path of a new adventure.
Recommended Skills Analytical Assessments Auditing Biology Business Process Improvement Coaching And Mentoring Estimated Salary: $20 to $28 per hour based on qualifications.
Job Title:
Quality Associate III Location:
100% onsite in Marion, NC (North Cove) Duration:
6 months with the possibility of extension/conversion Hours:
Standard business hours Position 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.
Why Work for Us Here at Experis, We care about people and the role of work in their lives.
We respect people as individuals, trusting them, supporting them, and enabling them to achieve their aims in work and in life.
We have been recognized in multiple ways for our ability to do this successfully.
if you are interested in working with us and learning more about this opportunity, Click the apply button now and start the path of a new adventure.
Recommended Skills Analytical Assessments Auditing Biology Business Process Improvement Coaching And Mentoring Estimated Salary: $20 to $28 per hour based on qualifications.
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