QA Specialist II
QA Specialist II shop floor is responsible for real time batch record review, execution of QA walkthroughs, removal of Out-of-Service Tags, approval of suite change-overs, line clearance, product transfers, and product shipments. according to related SOPs to meet local, Global and Regulatory requirements. Through their fundamental knowledge, assists manufacturing associates by providing Quality Assurance support for operational areas involved in the execution of GMP-related activities.
- Review and approve GMP documentation against Standard Operations Procedures to ensure manufacturing steps are appropriately documented, observations are clear, and Good Documentation Practices are followed.
- Conduct QA walkthroughs on the manufacturing floor for detection of non-compliance issues, inspection risks, and procedural or GMP non-compliances. Perform assessments by collecting and analyzing accurate, objective evidence regarding risks and their magnitude.
- Approve manufacturing suite change-overs, and line clearance activities. Verify release requirements for areas and equipment, and remove Out-of-service tags.
- Identify areas of non-conformance. Complete minor deviations and support root cause investigations.
- 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.
- Perform other duties as assigned.
Field of Study
Chemistry or Biological Sciences with Analytical Chemistry or Laboratory Work
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
your application has been submitted
Back to job search