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Reference Number:
4897MA_LdInvestigation_TK
Job Description:
Description:
? Lead investigator within the Manufacturing Investigations group.
? The investigation group is responsible for overseeing investigations for all 3 manufacturing suites in Andover, including both mammalian and bacterial based processes in support of commercial and clinical Drug Substance manufacture.
? Responsibilities include
? investigations related to all deviations including process and equipment deviations and deviations in analytical assays.
? Responsible for performing thorough, detailed and timely investigations and generation of high quality and timely investigation reports.
? The individual will be expected to establish collaborative relationships with the operational staff in each suite and the appropriate Quality and Functional Area representatives in order to facilitate investigations.
? The incumbent will ideally have a significant amount of experience in the area of quality and compliance and a detailed working knowledge of the appropriate regulations.
? Should be able to multi task and work independently.
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
? Working with the appropriate people from both the quality and operational organizations develop a corrective action
? Ensures their investigations are conducted with a strict adherence to appropriate quality and compliance standards
? Ensure all investigation they are responsible for meet regulatory/corporate standards.
? Requirements BS or MS in a scientific or engineering discipline with 3+ years. A strong technical background in a cGMP and Quality environment is required. Prior experience with investigations including conducting and writing investigations preferred.
The incumbent must be a collaborative team player with strong coordination and facilitation skill. MOST CRITICAL: Knowledge of the processes used to manufacture biologics and a understanding of the quality systems and practices used to investigate, document and correct atypical events that occur in the process
PHARMA EXPERIENCE IS REQUIRED --> Experience in the manufacture of Bio pharmaceuticals is needed.
REQUIRED PERSONALITY TRAITS: Attention to detail, ability to work on more than one issue at a time, able to handle deadlines and stress.
INITIAL 6 MONTH ASSIGNMENT WITH THE POTENTIAL OF BEING EXTENDED UP TO ONE YEAR IN LENGTH.
MUST HAVE AT LEAST 3-5 YEARS RELATED EXPERIENCE.
Experience Level:
Unspecified
Requirements:
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