Job Description

Job Title : Quality Assurance Lead Investigator 
Location : Andover, MA
Type: Contract
 
Overview
Leading pharmaceutical company looking for an experienced Quality Assurance Lead Investigator. Ideal candidates should have a High School Diploma with 10-15 years of relevant experience, or a Bachelors degree with 5-8 years of relevant experience, or most preferably a Masters degree with 3-6 years of relevant experience. 
 
Responsibilities

• Have a fundamental understanding of the investigation process as it applies to manufacturing and laboratory issues
• Have detailed understanding of the processes and systems involved in the manufacture of bio pharmaceuticals. Be able to use that knowledge to investigate process deviations and atypical results.
• Ensure investigations are conducted with a strict adherence to appropriate quality and compliance standards
• Ability to coordinate and facilitate meetings, lead conversations, and influence teams
• Work under limited supervision, with the ability to problem solve, manage priorities, and make decisions independently.
• Act as Subject Matter Expert for the Investigations group, mentoring and providing guidance to other colleagues.
• Drive/contribute to the completion of complex projects and take responsibility for a portion of the team’s milestones/deliverables.
• Exercise positive communication techniques to maintain relationships and gain consensus in group scenarios with multiple stakeholders.
• Promote adherence to root cause analysis and human error reduction tools

Requirements

• High School Diploma with 10-15 years relevant experience
• Bachelor’s degree (preferably in Science or Engineering discipline) with 5-8 years relevant experience
• Master’s degree (preferably in Science or Engineering discipline) with 3-6 years relevant experience
• Demonstrated expertise in pharmaceutical/biological manufacturing and/or laboratory operations
• Strong technical background in a cGMP and Quality environment
• Significant experience in leading complex investigations and cross-functional project teams
• Versed in navigating deviation management systems and business processes
• Demonstrated knowledge and application of lean six sigma principles and continuous improvement methodology

Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan. 

Ref: #568-Clinical

Job Tags

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