Quality System Analyst Promega
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JOB OBJECTIVE: This position will support both existing and future Quality System processes that are managed by EtQ Reliance, SAP and other non-product software. Serves as EtQ Reliance system administrator. Leads projects to support the ongoing extension and improvement EtQ Reliance (EtQ) and other non-product software.
Electronic Quality Management System
Serves as QA Lead to implement, improve, and maintain the electronic quality management system by performing the following:
1. Serves as overall EtQ Reliance system administrator.
2. Leads cross-functional projects to implement the electronic quality management system including user requirements, design specifications, traceability matrixes, software configuration, testing, verification, and validation.
3. Ensures project documentation is complete and compliant with site procedures.
4. Participates in continuous improvement activities aimed at reducing activity delays, eliminating redundancies, and increasing throughput.
5. Aids in quality system monitoring and continuous improvement activities by developing and maintaining reports utilizing report writing tools such as Business Objects, Crystal Reports, or Cognos to present quality data and analyze data for trends and opportunities for improvements.
6. Acts as liaison between internal departments and third-party vendors for electronic quality management implementation and maintenance activities.
Serves as QA Lead to support Quality Assurance and Regulatory Affairs by performing the following functions in SAP:
1. Creates and maintains criteria for inspection lot management for new products and for changes to existing products.
2. Implements changes to information maintained by QA and Regulatory Affairs, such as regulatory information, product acceptance criteria and product shelf life.
3. Conducts SAP queries to support quarantine of nonconforming materials, complaint investigation change control, deviations, Management Review metrics, customer inquiries and customer audits.
4. Monitors product quality data and investigate discrepancies, assist with driving corrective action to resolution.
1. Represents Quality Assurance on cross-functional teams for ongoing extension and improvement of SAP, EtQ, NICE and other software.
2. Creates standard operating procedures, training plans and other user documentation.
3. Understands and complies with ethical, legal and regulatory requirements applicable to our business.
1. Supports new product release process through expertise in software system to gather new product requirements.
2. Runs queries on complaints for complaint investigation, product teams and CAPA/Management Review.
3. Represents Promega in discussions/interactions with partners, vendors, or customers during external audits.
4. Provides support to Promega?s quality system by assisting QA/RA and other departments in quality system improvement activities.
5. Other duties as assigned.
1. Bachelor's degree in computer science, engineering or information technology.
2. 5 or more years experience in a formal software development role, preferably supporting a Quality System.
3. Knowledge of regulations and standards affecting IVDs or other regulated products.
4. Project Management experience including planning/managing resources and applying project management principles and techniques for software project planning, implementation, and tracking.
5. Experience configuring, implementing, and maintaining electronic quality management systems such as EtQ Reliance or Pilgrim SmartSolve.
6. Experience utilizing report writing tools such as Business Objects, Crystal Reports, or Cognos.
7. Adept at solving problems and recommending possible solutions.
8. Effective written and verbal communication skills.
9. Excellent interpersonal and leadership skills.
10. Work in a team environment. Assist team members in accomplishing assigned tasks/projects.
1. Professional certification in software quality e.g. American Society for Quality (ASQ) Software Quality Engineer Certification.
2. Professional certification in project management.
3. Experience with SAP and EtQ Reliance.
1. Ability to use computer programs (Microsoft Office Suite), office tools, equipment.
2. Ability to sit for prolonged periods of time.
Promega Corporation is an Affirmative Action/Equal Opportunity Employer
Madison, Wisconsin, United States
||2800 Woods Hollow Road |
Madison, WI 53711
THIS JOB HAS EXPIRED