Quality Assurance Specialist

CONTRACT: 6-month extendableMUST HAVES: Bachelor’s degree in science or equivalent degree. 2-5 years’ experience in Quality with a pharmaceutical company or similarly regulated industry. Knowledge of CGMP and GDP as well as FDA trends and guidelines. Position Overview: The Quality Assurance Specialist position is responsible for Document and Training Management Programs.

This will require working with our external Safety Data Sheet Vendor, monitoring the periodic review process for controlled documents, supporting day to day activities associated with the document lifecycle, monitoring training, performing annual training assessments and supporting the change control, batch review and new product launch activities, as needed. Previous experience with document or training management in a CGMP environment is a plus. Essential Duties: Responsible for Administration of Document Management ProcessWorks in collaboration with Safety Data Sheet Vendor and contract manufacturing partners to obtain necessary documents for vendor to develop Safety Data Sheets.

Initiates, processes and monitors Controlled Documents within TrackWise Ditigal System including but not limited to Policies, Procedures, Work Instructions and Safety Data Sheets. Formats red-lined or updated Controlled Documents in collaboration with document owners, as necessaryMonitors Controlled Document periodic review cycle updates and works in collaboration with Document Owners, external vendors, and partners, as applicable, to meet review timelines. Responsible for Administration of Training Management Process for all departments. Creates new and updates exsisting Training Plans in TrackWise Digital in collaboration with department management. Creates on the Job Training in TrackWise Digital in collaboration with department management, as needed.

Creates Training Quizzes in TrackWise Digital, in collaboration with document or training owners, as needed. Assigns training within TrackWise Digital system to new employees and exsisting employees, as needed. Monitors employees training to completion ensuring training timelines are met. Prepares and Presents Annual CGMP presentation in collabration with other Quality team members. Conducts Annual Training Assessment. Conducts New Employee Training for TrackWise Digital, Adobe Sign, and Master Product Portal. Prepares training metrics for Management Review. Supports management during external inspections. Remains current in regulatory trends and requirements. Other duties as assigned.

Strong organization skills and attention to detail is a requirement. Requirements: Bachelor’s degree in science or equivalent degree. 2-5 years’ experience in Quality with a pharmaceutical company or similarly regulated industry. Knowledge of CGMP and GDP as well as FDA trends and guidelines. Strong interpersonal skills required. Must be a team player with good problem solving and good verbal and written communication skills. Must be able to handle multiple projects concurrently. Ability to manage indirect relationships and projects successfully. Strong organization skills and attention to detail required. Travel: No travel required. Computer Skills:

Microsoft Word, PowerPoint, Excel, TrackWise Digital, Adobe Sign preferred but not required