US - Quality Assurance Expert 3

Title : Quality Assurance Project Specialist (internal - QA Liasson)

Pay : $30 / HR

15 month, likely temp only

6 / 9am start time - 8.5 hours (including break from that start time)

Starting 100% on-site and could move to a 2-3 day hybrid

On-site Interviews

GMP experience - preferred

Not afraid to take on new challenges

Self-Driven

Experience dealing with auditors

Mandatory system's experience :

Mango

Trackwise

SAP

MS Suite

ISO - 9001

Preferred : Power Apps

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.

• Oversee the instrument calibration program

o Maintain the schedule for instrument calibration

o Assure that instrument onboarding, IQ / OQ activities and retirement documentation is

complete, accurate, appropriate, and archived per departmental policies

o Ensure LIMS accuracy for equipment calibration task completion

o Coordinate the execution of calibration tasks and confirm completion due dates are

met

o Support and assist with out-of-calibration investigation and completion of quality

incident reporting documentation

o Collaborate with laboratory staff / metrologist on new equipment and technology

o Review quality-supporting documentation, such as calibration records, instrument

initiation / retirement documentation, and quality incident reporting documentation

o Perform Good Documentation Practices (GDP) Audits

o Familiarize oneself with the Corporate Data Integrity guidelines

o Interact with the metrologist and digital liaison to determine compliance to Corporate

Data Integrity guidelines

o Oversee the CAPA system to ensure appropriate investigations are performed and

resolution is achieved in a timely manner

o Lead CAPA investigation to ensure appropriate actions are performed and resolution is

achieved to meet internal / external customer expectations

o Lead investigation and resolution for quality complaints, that require direct interaction

with customers

o Respond to quality-related customer questions

o Assist with complaint handling and investigations

o Understand the current change management system including change request

submissions

o Understand global, local and customer requirements for change control processing

o Review local changes for compliance to change control policies

o Assist external departments with change control queries

o Review local quality procedures for accuracy and compliance to Corporate policy

o Oversee the operating procedure review system

o Identify opportunities for process improvements and develop project plans

o Develop improvement ideas, review impact of changes and document work.

o Maintain positive proactive approach toward quality compliance, productivity

improvement, act as a proven agent of change

o Have a strong grasp of the business needs / requirements and processes; use

understanding of how relevant areas integrate to achieve objectives

o Technical and regulatory reviewer for documentation and protocol changes

o In compliance with change control procedures, improve processes through application

of scientific knowledge, experience, and principles

o Provide technical support to personnel to assist in problem solving

o Coordinate activities / experiments performed by Quality Control personnel as directed

by the Validation Coordinator and communicate updates / results back to the Validation

Coordinator

o Support investigation of non-conforming processes and products

o Keep management informed of potential and / or existing concerns or roadblocks

o Interface with internal / external customers

o Provide complete and accurate records consistent with quality guidelines

o Participate in governmental regulatory audits as needed

o Provide logical explanations and potential solutions

o Participate in functional process improvements

o Participate in project or process improvement initiatives

o Routinely support ongoing process improvements with the department and the

organization, ensuring efficient and value-added processes

o Provide technical support to cross-functional teams or other business units

o Interact with other departments as needed

o Train new QA liaisons within the department

o Supply information based on experience and knowledge

o Train personnel on processes and procedures by supplying sufficient demonstration,

theory and support

o Mentor personnel within the team

o Present various quality system training topics such as updated operating procedures

and quality requirements to laboratory and quality personnel on a monthly basis

Education :

Work Experience :

Job Specific Competencies and Skills :