Quality Assurance Lead Investigator
Location: Andover
Posted on: June 23, 2025
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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
Keywords: , Chicopee , Quality Assurance Lead Investigator, Science, Research & Development , Andover, Massachusetts
