Description:
SUMMARY OF POSITION:
The Quality Assurance Technician II performs a variety of review process with the intent to correct record errors in manufacturing process documentation that includes batch record review and documentation issue resolution. This role is also responsible for return good inspections, (current Good Manufacturing Practices) cGMP area inspections and product inspections. This role ensures QA compliance and that cGMP principles are adhered to.
ESSENTIAL FUNCTIONS:
• Execute batch record review and document deficiencies in a computerized system
• Identify exceptions and report exceptions to production
• Resolve documentation discrepancies and issues with manufacturing operations personnel in a timely manner to allow for material release
• Perform batch record accountability and Iron Mountain box reconciliation
• Execute line clearances and assist in inspection of returned goods
• Follow all internal and basic cGMP guidelines for pharmaceutical operations
• Perform GMP walkthroughs with production on a routine basis
• Participate in cross-functional teams to improve review efficiency and support
• Adhere to all safety rules and maintain 100% completion of all safety required training
• Maintain 100% on time compliance wire training
MINIMUM REQUIREMENTS:
Education:
HS Diploma is required; Associates or Bachelor’s degree is preferred.
Experience:
• Minimum of 1-3 years of document review experience in a cGMP environment preferred. Proven knowledge of FDA and cGMP regulations preferred. Proficiency in MS Word and Excel. LIMS and BPCS experience preferred.
Knowledge/Skills/Qualifications:
• Ability to communicate at a high level of written and oral skills
• Ability to read and comprehend complex calculations and formulas
• Ability to focus and review batch records for an extended period of time
• Knowledge of GMPs for APIs
• Ability to quickly identify, communicate and/or resolve issues
• Ability to read and understand complex batch records
• Ability to keep batch records organized and easily retrievable at all times
• Excellent verbal and written communication skills
• Ability to understand and apply good documentation practices
• Ability to build relationships with partners