Quality Lab Associate at Rose International

Requirement Number:26045

Duration: 6-8 week assignment

Required Education and Experience:
• Bachelor''s degree in science or engineering; advanced degree in the life sciences, physical sciences or engineering, with 2-3 years of experience in root cause evaluation, interpreting regulations and quality systems.
• Minimum of 5-8 years of experience in Manufacturing Operations and or Quality, or related field in the medical products industry.

Job Responsibilities
• Determine scope, product impact, root cause and corrective actions for deviations from manufacturing procedures. Determine appropriate preventive actions to avoid reoccurrence of the deviation.
• Conduct personnel interviews to determine root cause of the deviation.
• Foster collaborative relationships focused on high quality investigations, meaningful corrective actions and the reduction of deviation generation rate.
• Set up and run meetings with cross functional teams.
• Close deviations in a timely manner to meet business and compliance needs.
• Work with minimal supervision to drive deviations to closure.
• Work with Subject Matter Experts and Quality Approvers to determine the breadth and scope of the investigation to identify the appropriate root cause, implement corrective and preventive actions, complete trending analysis, and recommend product disposition.
• Present and defend investigations during regulatory inspections, as required.
• Sustain a clean and sale work area using 6S principles
• Learn, understand and apply rigorous quality standards, Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP)

Knowledge, Skill and Abilities:
• Strong communication and project management skills. Must have a thorough understanding of pharmaceutical manufacturing process and equipment, preferably parenteral solutions, and current Good Manufacturing Practices (cGMPs).
• Must have good analysis, troubleshooting, and investigation skills. Must be able to put complex thoughts and issues into writing in such a manner than an educated, but uninformed reader can understand and make decisions based on the written investigation report.
• Must be able to interact with, and influence others at various levels in multiple departments.
• Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawings.
• Must have basic English written and oral communication skills adequate to communicate with other team members.

Benefits:

For information and details on employment benefits offered with this position, please visit here .Should you have any questions / concerns, please contact our HR Department via our secure website .

California Pay Equity:
For information and details on pay equity laws in California, please visit the State of California Department of Industrial Relations' website here.

Rose International is an Equal Opportunity Employer.All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender(expression or identity), national origin, arrest and conviction records, disability, veteran status or any other characteristic protected by law.Positions located in San Francisco and Los Angeles, California will be administered in accordance with their respective Fair Chance Ordinances.

If you need assistance in completing this application, or during any phase of the application, interview, hiring, or employment process, whether due to a disability or otherwise, please contact our HR Department.

Rose International has an official agreement (ID #132522), effective June 30, 2008, with the U.S. Department of Homeland Security, U.S. Citizenship and Immigration Services, Employment Verification Program (E-Verify). (Posting required by OCGA 13/10-91.).