job summary: 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 calibrationAssure that instrument onboarding, IQ/OQ activities and retirement documentation is complete, accurate, appropriate, and archived per departmental policiesEnsure LIMS accuracy for equipment calibration task completionCoordinate the execution of calibration tasks and confirm completion due dates are metSupport and assist with out-of-calibration investigation and completion of quality incident reporting documentationCollaborate with laboratory staff/metrologist on new equipment and technologyReview 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) AuditsFamiliarize oneself with the Corporate Data Integrity guidelinesInteract with the metrologist and digital liaison to determine compliance to Corporate Data Integrity guidelinesRespond to customer complaints and audit findings Oversee the CAPA system to ensure appropriate investigations are performed and resolution is achieved in a timely mannerLead CAPA investigation to ensure appropriate actions are performed and resolution is achieved to meet internal/external customer expectationsLead investigation and resolution for quality complaints, that require direct interaction with customersRespond to quality-related customer questionsAssist with complaint handling and investigations Gatekeeper for Local Quality Control Change Control Understand the current change management system including change request submissionsUnderstand global, local and customer requirements for change control processingReview local changes for compliance to change control policiesAssist external departments with change control queries Write and modify procedures Review local quality procedures for accuracy and compliance to Corporate policyOversee the operating procedure review systemIdentify opportunities for process improvements and develop project plansDevelop improvement ideas, review impact of changes and document work.Maintain positive proactive approach toward quality compliance, productivity improvement, act as a proven agent of changeHave a strong grasp of the business needs/requirements and processes; use understanding of how relevant areas integrate to achieve objectivesTechnical 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 principlesProvide technical support to personnel to assist in problem solvingCoordinate 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 productsKeep management informed of potential and/or existing concerns or roadblocks Participate in customer/internal audits Interface with internal/external customersProvide complete and accurate records consistent with quality guidelinesParticipate in governmental regulatory audits as neededProvide logical explanations and potential solutionsParticipate in functional process improvements Actively participate in Quality Systems implementations, upgrades and improvements Participate in project or process improvement initiativesRoutinely support ongoing process improvements with the department and the organization, ensuring efficient and value-added processesProvide technical support to cross-functional teams or other business unitsInteract with other departments as needed Train local Quality Control employees on new or updated policies and procedures Train new QA liaisons within the departmentSupply information based on experience and knowledgeTrain personnel on processes and procedures by supplying sufficient demonstration, theory and supportMentor personnel within the teamPresent 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 SAPExperience with ISO 9001 Preferred: SAP QM experienceExperience with ISO 14001 #LI-KH1 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.