The Quality Assurance Technical Writer is responsible for writing policies and procedures (P&P) and managing the P&P release process. In addition, this role will provide administrative assistance to the Senior Manager Quality Assurance such as tracking project deliverables, generating reports and presentations.
DUTIES
Writes and revises policies/procedures (P&P) and creates process flow charts.
Works with pharmacy operations and support personnel to fully understand and accurately document the processes.
Manages the P&P approval/release process, maintains P&P master list and compliance matrix.
Tracks deliverables for project initiatives.
Monitors adherence to complaint/incident/CAPA processes and reports overdue actions.
Conducts internal quality process audits periodically.
Prepares various reports, presentations, meeting agendas and minutes.
Analyzes operational/business metrics and trends.
Recommends process improvements.
Participates on quality improvement activities as appropriate for position.
Provides administrative support to Sr. Manager Quality Assurance as needed.
QUALIFICATIONS
Essential Physical Requirements:
Ability to operate computer, phone, copier, fax, calculator, and other office equipment as applicable.
Prolonged sitting.
Qualifications:
Bachelor of Science or Arts degree in English, Journalism, Computer Science or Industrial Engineer is required.
Education and Experience:
5+ years relevant experience.
Previous Quality Assurance experience desired.
Relevant Pharmacy Operations technical knowledge is a plus.
Exceptional verbal/written communication skills, as well as grammatical skills.
Ability to work independently in a fast paced team environment.
Conscientious with exceptional attention to detail.
Excellent organizational and time management skills.
Proficient with PC applications, including Microsoft Office Word, Excel, and PowerPoint.
Travel:
Minimal travel required.
Writes and revises policies/procedures (P&P) and creates process flow charts.
Works with pharmacy operations and support personnel to fully understand and accurately document the processes.
Manages the P&P approval/release process, maintains P&P master list and compliance matrix.
Tracks deliverables for project initiatives.
Monitors adherence to complaint/incident/CAPA processes and reports overdue actions.
Conducts internal quality process audits periodically.
Prepares various reports, presentations, meeting agendas and minutes.
Analyzes operational/business metrics and trends.
Recommends process improvements.
Participates on quality improvement activities as appropriate for position.
Provides administrative support to Sr. Manager Quality Assurance as needed.
