We are currently looking to fill multiple Investigation Specialist positions. These positions perform all compliance related tasks vital to complete investigations and implementation of robust corrective actions for supporting manufacturing operations.
Current Departments with Openings :
Manufacturing
Quality Assurance
Quality Control
Technical Operations
In this role, a typical day might include the following :
Independently investigating non conformances and preventing reoccurrences in support of manufacturing operations
Preparing investigation reports that include recommendations on investigation findings for medium / high severity non conformances
Analyzing and evaluating information captured through investigations, summarizes information and trends in investigation reports
Communicating findings and recommendations at group meetings
Reviewing completed batch records and logbooks in accordance with cGMP standards in support of investigations
Reviewing, editing, and revising controlled documents (batch records, logbooks, SOPs, etc.) in accordance with cGMP standards to ensure compliance with written procedures
Monitoring production processes to acquire vital data in support of investigations and track efficiency of changes
Participating in and / or leading cross-functional study teams to get results, support and or author investigations
Gathering, trending, and analyzing process related data to drive consistency and timeliness
Documenting all training
Training new employees on investigative processes and techniques
Coordinating and / or leading cross-functional meetings with multiple departments.
This role may be for you if you :
Excel in a quality driven organization
Have an understanding of biologics manufacturing operations
Are organized and have an attention to detail
Can prioritize multiple assignments and changing priorities
Are able to learn and utilize computerized systems for daily performance of tasks
To be considered for this role you must hold a Bachelor’s degree in Life Sciences, Engineering, or related field and the following minimum amounts of relevant experience for each level :
Associate Specialist 0-2+ years
Specialist 2+ years
Senior Specialist 5+ years
May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.
REGNEC
QA Investigation Specialist
We are currently looking to fill a QA Investigation Specialist position. Preparing investigation reports that include recommendations on investigation findings for medium/high severity non conformances. Analyzing and evaluating information captured through investigations, summarizes information and ...
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We are currently looking to fill multiple Investigation Specialist positions. Preparing investigation reports that include recommendations on investigation findings for medium/high severity non conformances. Analyzing and evaluating information captured through investigations, summarizes information...
Investigation Specialist
We are currently looking to fill multiple Investigation Specialist positions. Preparing investigation reports that include recommendations on investigation findings for medium/high severity non conformances. Analyzing and evaluating information captured through investigations, summarizes information...
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We are currently looking to fill a QA Investigation Specialist position. Preparing investigation reports that include recommendations on investigation findings for medium/high severity non conformances. Analyzing and evaluating information captured through investigations, summarizes information and ...
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