We are currently looking to fill a QA Investigation Specialist position. This position performs all compliance related tasks vital to complete investigations and implementation of robust corrective actions for supporting manufacturing 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.