Lead Investigator (Quality Assurance Specialist) Position Available In Essex, Massachusetts

Job Description:

Job Title:

Lead Investigator (Quality Assurance Specialist)

Location:

Andover, MA, 01810

Duration:

9 months (Possibilities ofExtension)

Work Shift:

Monday

• Friday 9 am
• 5 pm

Pay Range:

$96.55

• $103.

44/Hour on W2

Job Description Summary:

The AndoverSite Production Operations Team is looking for an individual tofill a Senior Lead Investigator Position within the Investigationsgroup. The Andover Site Investigation group is responsible foroverseeing investigations for all GMP manufacturing suites inAndover, including both mammalian and bacterial based processes insupport of commercial and clinical Drug Substance manufacture. As asenior level position within the Site Investigation group theresponsibilities of this position will be multi-faceted. Theyinclude serving as the primary lead investigator on complexinvestigations related to all production operations, laboratory,and production support areas. The candidate will be responsible forperforming thorough, detailed and timely investigations andgeneration of high quality and timely investigation reports. Inaddition, this position will be responsible for assisting themanager of investigations in transforming the investigation processon site including development and implementation of continuousimprovement techniques. Duties of this position may also includecoaching and mentoring to staff members to enable them to meettheir established timelines, work commitments and further theirprofessional development. This position will report to theInvestigations Team Manager.

Role Responsibilities:

• The candidatewill be responsible for performing thorough, detailed, and timelyinvestigations and for the generation of high-quality investigationreports.
• The individual will be expected to develop collaborativerelationships with the operations, laboratory, quality, and othersupporting groups in order to facilitate investigations usingcontinuous improvement techniques.
• The incumbent will be expectedto have experience in the area of quality and compliance and aworking knowledge of GMPs.
• Experience with and in depthunderstanding of cell culture and chromatography is highlydesirable.
• The candidate will be expected to assist incontinually defining and improving the philosophy tools forinvestigations to meet changing business needs.