Are you a proactive and detail-oriented Quality Assurance professional with a passion for driving compliance? We're looking for a Quality Systems Specialist to be a central liaison for our Quality Control team. In this dynamic role, you will be the gatekeeper for local change control, the project lead for customer and audit investigations, and the technical expert who ensures our documentation and instrument calibration programs meet the highest standards. This is a critical opportunity for a professional who thrives on leading projects, improving processes, and ensuring quality excellence across the organization.
location: Milwaukee, Wisconsin
job type: Contract
salary: $25 - 30 per hour
work hours: 9 to 5
education: High School
responsibilities:
- 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 customers
- Respond to quality-related customer questions
- 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
- Review local changes for compliance to change control policies
- Assist external departments with change control queries
- Write and modify procedures
- Review local quality procedures for accuracy and compliance to Corporate policy
- Oversee the operating procedure review system
- Identify opportunities for process improvements and develop project plans
- Develop improvement ideas, review impact of changes and document work.
- Maintain positive proactive approach toward quality compliance, productivity improvement, act as a proven agent of change
- Have a strong grasp of the business needs/requirements and processes; use understanding of how relevant areas integrate to achieve objectives
- Technical and regulatory reviewer for documentation and protocol changes
- Support local Quality System projects
- In compliance with change control procedures, improve processes through application of scientific knowledge, experience, and principles
- Provide technical support to personnel to assist in problem solving
- Coordinate activities/experiments performed by Quality Control personnel as directed by the Validation Coordinator and communicate updates/results back to the Validation
- Coordinator
- Support investigation of non-conforming processes and products
- Keep management informed of potential and/or existing concerns or roadblocks
- Participate in customer/internal audits
- Interface with internal/external customers
- Provide complete and accurate records consistent with quality guidelines
- Participate in governmental regulatory audits as needed
- Provide logical explanations and potential solutions
- Participate in functional process improvements
- 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
- Interact with other departments as needed
- Train local Quality Control employees on new or updated policies and procedures
- Train new QA liaisons within the department
- Supply information based on experience and knowledge
- Train personnel on processes and procedures by supplying sufficient demonstration, theory and support
- Mentor personnel within the team
- Present various quality system training topics such as updated operating procedures and quality requirements to laboratory and quality personnel on a monthly basis
qualifications:
Required:
- High school diploma with 6 years of work experience OR 1-2 year vocation training/associates degree with 4 years of experience OR Bachelor's degree in Chemistry, or Other Life/Physical Science with 0-2 years of work experience
- Requires knowledge of Microsoft Office, Mango, TrackWise and SAP
- Experience with ISO 9001
- SAP QM experience
- Experience with ISO 14001
skills: Quality Assurance, GMP (Good Manufacturing Practice), Quality Assurance (QA)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
