QA MANAGER, DOCUMENTATION & TRAINING Job

QA MANAGER, DOCUMENTATION & TRAINING is needed to perform the following duties:

Daily QA Documentation and Training Activities (40%):

• Compile and report metrics for Quality Assurance Documentation and Training.
• Evaluates quality processes for alignment with cGMPs and evolving regulatory expectations.
• Assist with investigations and review/approve as needed.
• Review all controlled documents through Document Change Request (DCR) process.
• Implements and enforces systems, policies, and procedures.
• Assist HR with the creation and delivery of New Hire Orientation (NHO).
• Assist with audits, both internal and external.
QA Documentation & Training Department managing activities (40%):
• Oversee Quality compliance of the documentation and training programs throughout site.
• Responsible for the overall direction, coordination, and evaluation of the Document Control and Training departments.
• Lead and assist with maintaining the electronic Document Management System (DMS).
• Lead and assist with maintaining the electronic Learning Management System (LMS) for training.
• Maintain training curricula for positions at the site.
• Responsible for organizing and archiving cGMP documents on site.

Additional Activities (20%):

• Responsible for performance reviews, goal setting, and personnel development plans for Supervisor, QA Documentation Systems and QA Technicians - Documentation
• Providing regular performance feedback (praise and developmental) to members of QA Quality Operations team.
• Assists in recruiting, interviewing, and hiring qualified employees to fill open positions.
• Addressing complaints and resolving personnel problems within the department(s).
• Maintaining confidentiality of information.

Bachelor’s degree is required in Pharmaceutical Science or Pharmacy or Drug Regulatory affairs or Regulatory Affairs