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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
Job Title: Quality Assurance Project Specialist
Location: Milwaukee, WI
Duration: 15 Months+ (Temp to Perm)
Shift Details: 6/9am start time - 8.5 hours (including break from that start time) Starting 100% on-site and could move to a 2–3-day hybrid On-site Interviews GMP experience - preferred Not afraid to take on new challenges Self-Driven Experience dealing with auditors
Mandatory system's experience:
Power Apps
Summary:
Education:
Work Experience:
Job Specific Competencies and Skills:
#sczr2
Location: Milwaukee, WI
Duration: 15 Months+ (Temp to Perm)
Shift Details: 6/9am start time - 8.5 hours (including break from that start time) Starting 100% on-site and could move to a 2–3-day hybrid On-site Interviews GMP experience - preferred Not afraid to take on new challenges Self-Driven Experience dealing with auditors
Mandatory system's experience:
- Mango
- Trackwise
- SAP
- MS Suite
- ISO – 9001
Power Apps
Summary:
- 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
- Maintain the schedule for instrument calibration
- Assure that instrument onboarding, IQ/OQ activities and retirement documentation is complete, accurate, appropriate, and archived per departmental policies
- Ensure LIMS accuracy for equipment calibration task completion
- Coordinate the execution of calibration tasks and confirm completion due dates are met
- Support and assist with out-of-calibration investigation and completion of quality incident reporting documentation
- Collaborate with laboratory staff/metrologist on new equipment and technology
- 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
- Perform Good Documentation Practices (GDP) Audits
- Familiarize oneself with the Corporate Data Integrity guidelines
- Interact with the metrologist and digital liaison to determine compliance to Corporate Data Integrity guidelines
- Respond to customer complaints and audit findings
- Oversee the CAPA system to ensure appropriate investigations are performed and resolution is achieved in a timely manner
- Lead CAPA investigation to ensure appropriate actions are performed and resolution is achieved to meet internal/external customer expectations
- Lead investigation and resolution for quality complaints, that require direct interaction with customer
- Assist with complaint handling and investigations
- Gatekeeper for Local Quality Control Change Control
- Understand the current change management system including change request submissions
- Understand global, local and customer requirements for change control processing o Review local changes for compliance to change control policies
- Actively participate in Quality Systems implementations, upgrades and improvements
- Participate in project or process improvement initiatives
- Routinely support ongoing process improvements with the department and the organization, ensuring efficient and value-added processes
- Provide technical support to cross-functional teams or other business units
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
#sczr2
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