Sr. QA Specialist

Description

* Comply with all company policies and procedures, current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA) and other regulatory requirements.
* Support manufacturing and laboratory processes, investigations, change controls and quality improvement efforts.
* Perform routine quality audits of manufacturing and laboratory environments, equipment and procedures.
* Collaborate cross-functionally to solve issues and implement quality improvements impacting manufacturing and laboratory operations.
* Perform assigned tasks and work to achieve company goals and department objectives.
* Collaborate with management to establish and meet targets and timelines.
* Identify, design and implement process and system improvements.
* Apply advanced quality system theory and detailed knowledge of U.S. and European regulatory requirements to make sound quality decisions.
* Represent Quality Assurance (QA) on cross-functional teams.

General Duties

* Monitor and proactively manage trends in quality performance using advanced database tools and statistics to identify and implement continuous improvements within the quality systems.
* Review and approve complex quality system data and documentation.
* Write and revise standard operating procedures (SOP) and related documents.
* Investigate and resolve quality system discrepancies with minimal direction.
* Recognize quality system deficiencies and implement improvements.
* Support quality system audits, as required.
* Manage tracking and reporting databases and the associated metrics.
* Provide mentoring to other QA staff members, as required.
* Develop and deliver quality and compliance related training presentations, as required.

Requirements

* Bachelor's Degree in science, engineering or related field and at least six (6) years related experience, preferably in a quality assurance environment.
* Some supervisory and/or laboratory experience is preferred.
* Solid investigation, root cause analysis and problem solving skills.
* Ability to develop plans for implementation of corrective and preventive action measures.
* Strong organizational, time management and communication skills.
* Ability to negotiate through controversial issues with a balanced and diplomatic approach.
* Ability to handle multiple tasks simultaneously.
* Proficient with standard office software programs.

To find out more about Real Staffing please visit www.realstaffing.com