Position Summary:

This role acts as a document specialist and administrative support for the Final QC and Quality Assurance departments. Utilize database for production lots and prepares weekly folders and instrument schedules to ensure efficient processing of production lots. Facilitates procedure updates and change controls in documentation systems. Performs all duties using safety conscious and cGMP practices.

Position Duties:

• Maintains Disposable Manufacturing Lot Status database that QC utilizes for lot schedules for company use.
• Support tape test for incoming raw material and trains QC on the process (as applicable).
• Ensures proper inventory levels for laboratory and office area.
• Maintain organization and department Quality Procedures.
• Create and revise QC procedures into appropriate format for submittal through CR process.
• Design and maintain departmental forms.
• Support manual data to generate additional reports as requested.
• Support QC department metric outputs as applicable.
• Perform any additional specialized tasks/skills as defined by Quality Department.
• Support the storage or retrieval of QC records, perform monthly DHR audit review as applicable
• Act as liaison between QC and other departments for software updates and validations.
• Temporary modification to daily tasks to provide reasonable accommodations do not waive any essential functions of the job requirements.
• Reasonable, reliable attendance and punctuality is an essential job function required for this position.
• Laboratory assistance as needed (i.e. lot status labeling, physical inspections, instrument checks).
• Supports QC and other projects as requested by management.

Position Requirements:

• High School Diploma with 4 years of document control and coordination experience
• Requires strong computer skills including Microsoft Office Package (Access, Excel, Word, etc.).
• Must be able to demonstrate flexibility in responding to unexpected demands. Must also be able to work in a team environment, building effective working relationships.
• Requires effective written and oral communication skills.