Lead Quality Investigator
About this role
Company Description
Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.
Job Description
Job Description & QUALIFICATIONS:
- 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
- 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
Qualifications
Additional Information
Regards,
Anuj Mehta
973-967-3402
Frequently Asked Questions
Is the salary disclosed for the Lead Quality Investigator position at artechinformationsystemllc?
The salary for this Lead Quality Investigator role at artechinformationsystemllc is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the Lead Quality Investigator position at artechinformationsystemllc located?
This Lead Quality Investigator role at artechinformationsystemllc is based in Andover, Andover, MA, United States, MA, us. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the Lead Quality Investigator role at artechinformationsystemllc full-time or part-time?
This is listed as a Contract position. It is posted as a Lead Quality Investigator role at artechinformationsystemllc.
How do I apply for the Lead Quality Investigator position at artechinformationsystemllc?
Click the "Apply Now" button on this page. You will be redirected to artechinformationsystemllc's official application portal hosted on smartrecruiters where you can submit your application directly.
When was the Lead Quality Investigator job at artechinformationsystemllc posted?
This Lead Quality Investigator position at artechinformationsystemllc was posted on Aug 18, 2016. Apply as soon as possible — early applications are often reviewed first.
Lead Quality Investigator
artechinformationsystemllc
You'll be redirected to artechinformationsystemllc's official application page on SmartRecruiters.