Reviews Manufacturing batch records in accordance with current Good Manufacturing Practices (cGMP). Consults with QA Management to resolve quality issues in a timely manner.
* With guidance from Quality Specialists, compiles and reviews manufacturing batch records in accordance with cGMP and internal procedures in an efficient and timely manner.
* Assures that nonconformance/deviations are properly investigated and closed
* Compiles finished documents including testing records, nonconformance and animal-derived statements in order to generate COA's for shipments of finished product or cell bank vials
* Generates Manufacturing labels from approved label specifications
* Interacts with MFG staff to provide batch record comment resolution
* Signs changeover and line clearances documentation
* Enters batch record data into tracking database
* Ability to work in a team environment and independently as required
* Maybe required to work Holidays and weekends
* Maybe required to work Overtime
* Contributes to the overall operations and to the achievement of departmental goals
* Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures.
* Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices
* Performs other duties as assigned
Experience / Education
* 0-2 years of relevant experience
* Bachelors' degree in a science related field or equivalent experience Developing professional expertise, applies company policies and procedures to resolve a variety of issues
* Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.