Lead Quality Investigator

Artech Information System LLC; Andover (MA); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading IT staffing company in Andover is seeking a qualified Lead Investigator to manage investigations within the site operations group. The ideal candidate should hold a BS or MS in a scientific or engineering discipline with relevant experience in pharmaceutical manufacturing and quality compliance. This role entails performing detailed investigations and generating timely reports while collaborating with operational leaders to ensure adherence to quality standards. Strong skills in continuous improvement methodologies and a deep understanding of biopharmaceutical processes are crucial for success in this position.

Qualifications

• 4-6 years of experience in pharmaceutical and/or biological manufacturing operations.
• Experience with investigations and quality compliance.
• In-depth understanding of cell culture and chromatography.

Responsibilities

• Perform thorough investigations and generate high-quality reports.
• Develop relationships with operational leadership for effective investigations.
• Ensure strict adherence to quality and compliance standards.

Skills

Collaborative team player

Strong coordination and writing skills

Continuous improvement methodology

Education

BS or MS in a scientific or engineering discipline

Job 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. A minimum qualification of 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 use of continuous improvement 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.

Role Responsibilities

• 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

• 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 biopharmaceuticals; 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 to develop a corrective action.
• Ensure investigations are conducted with strict adherence to appropriate quality and compliance standards.
• Exercise judgment in developing practices, techniques and evaluation criteria for obtaining results.