Batch Record Reviewer

Proclinical is currently recruiting for a Batch record Reviewer for a medical device company located in Philadelphia, PA. Successful candidate will review manufacturing batch records in accordance with current Good Manufacturing Practices (cGMP). Consults with QA Management to resolve quality issues in a timely manner.

Job Responsibilities:

• 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

Skills and Requirements:

• 2 years of relevant experience dealing with Batch Records and Data Analysis
• Bachelors' degree in a science related field or equivalent experience

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Dominic Santoro at (+1) 215-531-5280 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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