Senior Specialist, Quality Assurance Technical Operations

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Summary: Quality Assurance Operations, Laboratory Operations Support is responsible for managing Quality Assurance aspects related to Quality laboratory operations. This includes quality oversight on laboratory-based initiatives such as technical transfers, equipment and method changes, investigations, and periodic trending and reporting. This role will liaise with internal partners (e.g. Quality control, analytical technology functions) in support of daily operations and conflict resolution, and act as a QA representative on associated projects related to Quality laboratory operations.

Major Duties and Responsibilities 

• Provides quality support through quality review and approval of investigations or change controls.  

• Reviews and approves discrepancy reporting, investigations and CAPAs associated with all areas of laboratory operations including, incoming, in-process, release, and stability testing.  

• Reviews and approves laboratory periodic trending and performance reports  

• Liaises with internal partners (e.g., Quality control, analytical technology functions) in support of daily operations and conflict resolution  

• Review and approval of validation/qualification/verification protocols and reports associated with new product or material entry. 

• Ensures clear communication on issues and timely escalation as applicable  

• Conducts quarterly walkthroughs of Quality Control laboratories 

• Represent QA in cross functional meetings 

• Provide training on QA owned procedures 

Knowledge and Skill 

• Knowledge of biotech bulk and finished product manufacturing and associated analytical testing is highly desirable.  

• Knowledge of US and EU cGMP regulations and guidance.   

• Knowledge of electronic systems including any of the following: LIMS, Veeva, LES, Empower, Maximo desirable 

• Past experience where one was required to work in a team-based environment with a diverse group of people. 

• Excellent writing and oral communication skills are required  

• Demonstrated attention to detail, and the ability to perform well in a team-based environment are required.  

• Demonstrated ability to effectively establish proper priorities and to communicate complex information clearly and concisely, and apply knowledge of subject matter expertise  

• Excellent computer skills and proficiency with MS Office is<