QA Specialist II

Description

 

• HS Diploma Required, Degree preferred
• Pharmaceutical or Biotech GMP experience and Supplier Quality
• MUST have experience in review and release of GMP batch documentation (a minimum of 2 years of work experience) in the pharma/biotech industries.
• This role is responsible for the review and approval of GMP documentation to ensure compliance in operational areas. Through their fundamental knowledge, assists manufacturing associates by providing Quality Assurance support for operational areas involved in the execution of GMP-related activities. Participates in deviations and root cause investigations. Focused responsibilities include batch record review, and review of QA Operations related SOPs to meet local, Global and Regulatory requirements.
• Responsible for the review and approval of cGMP documentation against Standard Operating Procedures in order to ensure compliance in Manufacturing processes.
• Raise deviations as needed in order to capture potential impacts to product quality.
• Revise or review standard operating procedures and submit procedural changes as needed to meet local, Global and Regulatory requirements.
• Co-represent QA in meetings or on project teams, learning decision making as a QA representative conferring with senior staff.
• Participates in deviations and root cause investigations.
• Identify areas of non-conformance. Complete minor deviations and support root cause investigations.
• Perform other duties as assigned.
  
   

Required Skills -

 

• Effective interpersonal communication.
• Must have effective verbal and written communication skills.
• Effective organizational skills and ability to plan and suggest resolutions to technical problems.
• Ability to handle multiple tasks concurrently and complete tasks in a timely manner. TrackWise, SAP, Excel.