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Job Requirements of Quality Assurance Project Specialist:
-
Employment Type:
Contractor
-
Location:
Milwaukee, WI (Onsite)
Do you meet the requirements for this job?
Quality Assurance Project Specialist
Careers Integrated Resources Inc
Milwaukee, WI (Onsite)
Contractor
Support the maintenance, development and improvement of Quality Systems for the department such as auditing, training, process validation, vendor management, equipment qualification, change control, complaint handling, and documentation control while remaining compliant with Corporate policies and initiatives. Thorough understanding of Quality System regulations and ISO Quality Systems.
Oversee the instrument calibration program
o Maintain the schedule for instrument calibration
o Assure that instrument onboarding, IQ/OQ activities and retirement documentation is
complete, accurate, appropriate, and archived per departmental policies
o Ensure LIMS accuracy for equipment calibration task completion
o Coordinate the execution of calibration tasks and confirm completion due dates are
met
o Support and assist with out-of-calibration investigation and completion of quality
incident reporting documentation
o Collaborate with laboratory staff/metrologist on new equipment and technology
o Review quality-supporting documentation, such as calibration records, instrument
initiation/retirement documentation, and quality incident reporting documentation
Manage the Data Integrity Program for Quality Control
o Perform Good Documentation Practices (GDP) Audits
o Familiarize oneself with the Corporate Data Integrity guidelines
o Interact with the metrologist and digital liaison to determine compliance to Corporate
Data Integrity guidelines
Respond to customer complaints and audit findings
o Oversee the CAPA system to ensure appropriate investigations are performed and
resolution is achieved in a timely manner
o Lead CAPA investigation to ensure appropriate actions are performed and resolution is
achieved to meet internal/external customer expectations
o Lead investigation and resolution for quality complaints, that require direct interaction
with customers
o Respond to quality-related customer questions
o Assist with complaint handling and investigations
Gatekeeper for Local Quality Control Change Control
o Understand the current change management system including change request
submissions
o Understand global, local and customer requirements for change control processing
o Review local changes for compliance to change control policies
o Assist external departments with change control queries
Write and modify procedures
o Review local quality procedures for accuracy and compliance to Corporate policy
o Oversee the operating procedure review system
o Identify opportunities for process improvements and develop project plans
o Develop improvement ideas, review impact of changes and document work.
o Maintain positive proactive approach toward quality compliance, productivity
improvement, act as a proven agent of change
o Have a strong grasp of the business needs/requirements and processes; use
understanding of how relevant areas integrate to achieve objectives
o Technical and regulatory reviewer for documentation and protocol changes
Support local Quality System projects
o In compliance with change control procedures, improve processes through application
of scientific knowledge, experience, and principles
o Provide technical support to personnel to assist in problem solving
o Coordinate activities/experiments performed by Quality Control personnel as directed
by the Validation Coordinator and communicate updates/results back to the Validation
Coordinator
o Support investigation of non-conforming processes and products
o Keep management informed of potential and/or existing concerns or roadblocks
Participate in customer/internal audits
o Interface with internal/external customers
o Provide complete and accurate records consistent with quality guidelines
o Participate in governmental regulatory audits as needed
o Provide logical explanations and potential solutions
o Participate in functional process improvements
Actively participate in Quality Systems implementations, upgrades and improvements
o Participate in project or process improvement initiatives
o Routinely support ongoing process improvements with the department and the
organization, ensuring efficient and value-added processes
o Provide technical support to cross-functional teams or other business units
o Interact with other departments as needed
Train local Quality Control employees on new or updated policies and procedures
o Train new QA liaisons within the department
o Supply information based on experience and knowledge
o Train personnel on processes and procedures by supplying sufficient demonstration,
theory and support
o Mentor personnel within the team
o Present various quality system training topics such as updated operating procedures
and quality requirements to laboratory and quality personnel on a monthly basis
Education:
High school diploma or
1-2 year vocation training/associates degree or
Bachelor s degree in Chemistry, or Other Life/Physical Science
Work Experience:
High school diploma and minimum of 6 years work experience or
1-2 year vocation training/associates degree and minimum 6 years work experience
Job Specific Competencies and Skills:
Requires knowledge of Microsoft Office
SAP experience (QM specifically) preferred
Computer skills
Troubleshooting skills
Organizational skills
Project Management skills
Communication skills, oral and written
ISO 9001:2015 familiarity
ISO 14001
Oversee the instrument calibration program
o Maintain the schedule for instrument calibration
o Assure that instrument onboarding, IQ/OQ activities and retirement documentation is
complete, accurate, appropriate, and archived per departmental policies
o Ensure LIMS accuracy for equipment calibration task completion
o Coordinate the execution of calibration tasks and confirm completion due dates are
met
o Support and assist with out-of-calibration investigation and completion of quality
incident reporting documentation
o Collaborate with laboratory staff/metrologist on new equipment and technology
o Review quality-supporting documentation, such as calibration records, instrument
initiation/retirement documentation, and quality incident reporting documentation
Manage the Data Integrity Program for Quality Control
o Perform Good Documentation Practices (GDP) Audits
o Familiarize oneself with the Corporate Data Integrity guidelines
o Interact with the metrologist and digital liaison to determine compliance to Corporate
Data Integrity guidelines
Respond to customer complaints and audit findings
o Oversee the CAPA system to ensure appropriate investigations are performed and
resolution is achieved in a timely manner
o Lead CAPA investigation to ensure appropriate actions are performed and resolution is
achieved to meet internal/external customer expectations
o Lead investigation and resolution for quality complaints, that require direct interaction
with customers
o Respond to quality-related customer questions
o Assist with complaint handling and investigations
Gatekeeper for Local Quality Control Change Control
o Understand the current change management system including change request
submissions
o Understand global, local and customer requirements for change control processing
o Review local changes for compliance to change control policies
o Assist external departments with change control queries
Write and modify procedures
o Review local quality procedures for accuracy and compliance to Corporate policy
o Oversee the operating procedure review system
o Identify opportunities for process improvements and develop project plans
o Develop improvement ideas, review impact of changes and document work.
o Maintain positive proactive approach toward quality compliance, productivity
improvement, act as a proven agent of change
o Have a strong grasp of the business needs/requirements and processes; use
understanding of how relevant areas integrate to achieve objectives
o Technical and regulatory reviewer for documentation and protocol changes
Support local Quality System projects
o In compliance with change control procedures, improve processes through application
of scientific knowledge, experience, and principles
o Provide technical support to personnel to assist in problem solving
o Coordinate activities/experiments performed by Quality Control personnel as directed
by the Validation Coordinator and communicate updates/results back to the Validation
Coordinator
o Support investigation of non-conforming processes and products
o Keep management informed of potential and/or existing concerns or roadblocks
Participate in customer/internal audits
o Interface with internal/external customers
o Provide complete and accurate records consistent with quality guidelines
o Participate in governmental regulatory audits as needed
o Provide logical explanations and potential solutions
o Participate in functional process improvements
Actively participate in Quality Systems implementations, upgrades and improvements
o Participate in project or process improvement initiatives
o Routinely support ongoing process improvements with the department and the
organization, ensuring efficient and value-added processes
o Provide technical support to cross-functional teams or other business units
o Interact with other departments as needed
Train local Quality Control employees on new or updated policies and procedures
o Train new QA liaisons within the department
o Supply information based on experience and knowledge
o Train personnel on processes and procedures by supplying sufficient demonstration,
theory and support
o Mentor personnel within the team
o Present various quality system training topics such as updated operating procedures
and quality requirements to laboratory and quality personnel on a monthly basis
Education:
High school diploma or
1-2 year vocation training/associates degree or
Bachelor s degree in Chemistry, or Other Life/Physical Science
Work Experience:
High school diploma and minimum of 6 years work experience or
1-2 year vocation training/associates degree and minimum 6 years work experience
Job Specific Competencies and Skills:
Requires knowledge of Microsoft Office
SAP experience (QM specifically) preferred
Computer skills
Troubleshooting skills
Organizational skills
Project Management skills
Communication skills, oral and written
ISO 9001:2015 familiarity
ISO 14001
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