Investigator Initiated Research (IIR) Associate

Pioneer Data Systems; Andover (MA); Sur place; USD 85 000 - 115 000; Temps partiel

Avantages offerts par ce poste

Medical insurance

Dental insurance

Vision insurance

Résumé du poste

SmartRecruiters, Inc. is seeking an Investigator Initiated Research (IIR) Associate in Andover, MA.

This 12-month contract role with potential extension involves leading investigations for GMP manufacturing, including bio process suites, and generating high-quality reports under the Site Investigations group. The candidate will collaborate with quality and operational teams, apply continuous improvement methods, and bring a strong background in quality systems and regulatory compliance.

Qualifications

• BS or MS in a scientific or engineering discipline with 2–6 years in pharma manufacturing.
• BS + 4-6 years experience or MS + 2-4 years experience in pharmaceutical/biological manufacturing.
• Experience with cGMP and Quality environment.
• Strong coordination, facilitation and writing skills.
• Experience in investigations and ongoing improvement methodologies.

Responsabilités

• Have a fundamental understanding of the investigation process as it applies to manufacturing issues.
• Understand processes and systems involved in biologics manufacture to investigate deviations and root causes.
• Work with quality and operations to develop corrective actions.
• Ensure investigations adhere to quality and compliance standards.
• Develop practices, techniques and evaluation criteria for obtaining results.

Connaissances

Investigations

Quality Assurance

GMP/cGMP

Root Cause Analysis

Cell Culture

Chromatography

Writing Skills

Facilitation

Coordination

Collaboration

Formation

BS or MS in scientific/engineering

Description du poste

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.
You may participate in the company group medical insurance plan which includes dental and vision.
Job Description:
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 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. The candidate will be responsible for performing thorough, detailed and timely investigations and generation of high quality and timely investigation reports. This position 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 and timely investigation reports.
The individual will be expected to develop collaborative relationships with the operational leadership and staff in each suite and the appropriate Quality and Functional Area representatives 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 the appropriate regulations. Experience with and in depth understanding of cell culture and chromatography is highly desirable. They will be expected to assist in continually defining and improving the philosophy and justifications involved in investigations and to continually evolve to meet changing business needs.
Additional responsibilities and expectations include:
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 bio pharmaceutical. 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 their 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
A BS or MS, preferably in a scientific or engineering discipline preferable. A minimum qualifications to BS + 4-6 yrs experience or MS + 2-4 yrs experience in a pharmaceutical and/or biological manufacturing operation with a strong technical background in a cGMP and Quality environment is required. Prior experience with investigations including conducting and writing investigations and in use of continuous improve methodology preferred. The incumbent must be a collaborative team player with strong coordination, facilitation and writing skills.

732-947-3452

By clicking the link above or any third-party link within this posting, you are leaving this site and going to a third-party website where the third-party website's terms and privacy policy apply