Investigator Initiated Research; IIR Associate

Investigator Initiated Research (IIR) Associate

• Contract

Position Details:
Job Title:
Quality Assurance Analyst / Pharma Manufacturing
Duration: 12 months contract, extendable up to 18 months

Location:

Andover, MA
Note: Client has the right-to-hire you as a permanent employee at any time during or after the end of contract.
Participate in the company group medical insurance plan which includes dental and vision.

The Andover Site Operations Management group is looking for an individual to fill a Lead Investigator position within the Andover Site Investigations group. The Andover Site Investigation group oversees investigations for all GMP manufacturing suites in Andover, including both mammalian and bacterial based processes in support of commercial and clinical Drug Substance manufacture. The candidate will report to the Manager of Investigations within the Site Operations Management Function.

The candidate will be responsible for performing thorough, detailed and timely investigations and generation of high quality investigation reports. The individual will develop collaborative relationships with operational leadership and staff in each suite and the appropriate Quality and

Functional Area

representatives to facilitate investigations using continuous improvement techniques. The candidate has experience in the area of quality and compliance and a working knowledge of the appropriate regulations. Experience with and in depth understanding of cell culture and chromatography is highly desirable. The candidate will assist in continually defining and improving the philosophy and justifications involved in investigations and continually evolve to meet changing business needs.

• Have a fundamental understanding of the investigation process as it applies to manufacturing issues
• Have detailed understanding of the processes and systems involved in the manufacture of biopharmaceutical. Be able to use that knowledge to investigate process deviations and atypical results and identify root cause
• Work with the appropriate people from both the quality and operational organizations develop a corrective action
• Ensure investigations are conducted with a strict adherence to appropriate quality and compliance standards
• Exercise judgment in developing practices, techniques and evaluation criteria for obtaining results

• BS or MS, preferably in a scientific or engineering discipline
• Minimum qualification:
  
  BS + 4-6 years experience or MS + 2-4 years experience in a pharmaceutical and/or biological manufacturing operation with a strong technical background in a cGMP and Quality environment
• Prior experience with investigations including conducting and writing investigations and use of continuous improvement methodology preferred
• Collaborative team player with strong coordination, facilitation and writing skills