job 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.
location : Milwaukee, Wisconsin
job type : Contract
salary : $35 - 40 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 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 documentationManage the Data Integrity Program for Quality ControlPerform Good Documentation Practices (GDP) Audits
Familiarize oneself with the Corporate Data Integrity guidelinesInteract with the metrologist and digital liaison to determine compliance to CorporateData Integrity guidelinesRespond to customer complaints and audit findingsOversee 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 expectationsLead investigation and resolution for quality complaints, that require direct interaction with customersRespond to quality-related customer questionsAssist with complaint handling and investigationsGatekeeper for Local Quality Control Change ControlUnderstand the current change management system including change request submissions
Understand global, local and customer requirements for change control processingReview local changes for compliance to change control policiesAssist external departments with change control queriesWrite and modify proceduresReview local quality procedures for accuracy and compliance to Corporate policy
Oversee 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 changesSupport local Quality System projectsIn compliance with change control procedures, improve processes through application of scientific knowledge, experience, and principles
Provide 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 CoordinatorSupport investigation of non-conforming processes and productsKeep management informed of potential and / or existing concerns or roadblocksParticipate in customer / internal auditsInterface with internal / external customers
Provide complete and accurate records consistent with quality guidelinesParticipate in governmental regulatory audits as neededProvide logical explanations and potential solutionsParticipate in functional process improvementsActively participate in Quality Systems implementations, upgrades and improvementsParticipate in project or process improvement initiatives
Routinely 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 neededTrain local Quality Control employees on new or updated policies and proceduresTrain new QA liaisons within the department
Supply 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 basisqualifications : Required :
High School Diploma or 1-2 year vocation training / Associates degree and at least 6 years work experience OR Bachelors degree in Chemistry, or Other Life / Physical Science and 3-6 years of work experiencePrior experience with Mango, SAP, and TrackWise (or equivalent systems)Experience with ISO 9001Proficiency with Microsoft OfficeExperience dealing with auditorsOther Skills : Troubleshooting, Organizational, Project Management, and Communication (oral and written)Preferred :
Experience with SAP QM or Power AppsExperience with GMP or ISO 14001ISO 9001 : 2015 familiarity#LI-KH1
skills : Corrective and Preventive Actions (CAPA), 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.