Quality Assurance Project Specialist QA Liasson

randstadlifesciences; Milwaukee (WI); On-site; USD 60,000 - 80,000; Full time

Job summary

A leading company is seeking a Quality Systems Specialist to oversee and improve their Quality Systems in Milwaukee. This contract role will involve responsibilities like managing calibration programs and responding to quality-related inquiries while ensuring compliance with regulatory standards. Ideal candidates will have a strong foundation in quality assurance, project management skills, and relevant educational background, with the potential for a rewarding salary and benefits package.

Benefits

Comprehensive benefits package including medical, dental, and vision

401K plan

Short-term disability

Qualifications

• High school diploma and minimum of 6 years work experience, or associates degree with the same experience.
• Familiarity with ISO 9001:2015 and ISO 14001.

Responsibilities

• Support the maintenance and improvement of Quality Systems including auditing and training.
• Oversee the instrument calibration program and ensure compliance with change control.
• Respond to customer complaints and manage the CAPA system.

Skills

SOP

Quality Assurance

CAPA

GMP (Good Manufacturing Practice)

Education

High school diploma or associates degree in Chemistry

Bachelor's degree in Chemistry or Other Life/Physical Science

Tools

Microsoft Office

SAP (QM specifically)

Job description

Job Description

Job Description

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: $30.00 - 33.65 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:

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

#LI-SB2

skills: SOP, Quality Assurance, CAPA, GMP (Good Manufacturing Practice)

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 [e-mail].

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.