Lead Investigator (Quality Assurance Specialist)
Location: Andover
Posted on: June 23, 2025
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Job Description:
Job Title: Lead Investigator (Quality Assurance Specialist)
Location: Andover, MA, 01810 Duration: 9 months (Possibilities of
Extension) Work Shift: Monday - Friday 9 am – 5 pm Pay Range:
$96.55 - $103.44/Hour on W2 Job Description Summary: The Andover
Site Production Operations Team is looking for an individual to
fill a Senior Lead Investigator Position within the Investigations
group. The Andover Site Investigation group is responsible for
overseeing investigations for all GMP manufacturing suites in
Andover, including both mammalian and bacterial based processes in
support of commercial and clinical Drug Substance manufacture. As a
senior level position within the Site Investigation group the
responsibilities of this position will be multi-faceted. They
include serving as the primary lead investigator on complex
investigations related to all production operations, laboratory,
and production support areas. The candidate will be responsible for
performing thorough, detailed and timely investigations and
generation of high quality and timely investigation reports. In
addition, this position will be responsible for assisting the
manager of investigations in transforming the investigation process
on site including development and implementation of continuous
improvement techniques. Duties of this position may also include
coaching and mentoring to staff members to enable them to meet
their established timelines, work commitments and further their
professional development. This position will report to the
Investigations Team Manager. Role Responsibilities: · The candidate
will be responsible for performing thorough, detailed, and timely
investigations and for the generation of high-quality investigation
reports. · The individual will be expected to develop collaborative
relationships with the operations, laboratory, quality, and other
supporting groups in order to facilitate investigations using
continuous improvement techniques. · The incumbent will be expected
to have experience in the area of quality and compliance and a
working knowledge of GMPs. · Experience with and in depth
understanding of cell culture and chromatography is highly
desirable. · The candidate will be expected to assist in
continually defining and improving the philosophy tools for
investigations to meet changing business needs.
Keywords: , Marthas Vineyard , Lead Investigator (Quality Assurance Specialist), Manufacturing , Andover, Massachusetts
