Job Description

Role: Quality Assurance

**Location: Wayne, PA

Duration: 12 Months Contract**

Job Summary:

• Perform audits of basic records and reports and inspections of routine processes to assure compliance with applicable regulatory requirements, international standards, and corporate policies and procedures.

ESSENTIAL DUTIES AND RESPONSIBILITIES:- Assure client's compliance with applicable federal, state, and local regulations as well as corporate policies to avoid any business interruptions.

• Communicate all identified compliance and quality risks to supervisor.

• Perform data audits to assess that records are attributable, legible, contemporaneous, original, accurate, and in compliance with regulations, international standards, SOPs, protocols/batch records, and corporate policies and procedures.

• Review SOPs, protocols/batch records, reports, and other quality and regulated records for accuracy, completeness, and compliance with atl applicable regulations, international standards, and corporate policies and procedures.

• Maintain written and signed records of all audits and inspections as required and may sign records documenting the performance of audits and inspections and reporting to management.

• Participate in the preparation and review of study/batch record and QA files in preparation for sponsor/client site visits; assure that QA audit files are retained.

• May participate in the hosting of client site visits and support regulatory inspections.

• Participate in the development of corrective and preventative actions to respond to client visit and regulatory inspection findings.

• Identify, document, and report deviations from regulations, protocols/batch records, SOPs, and specifications.

• Review protocols and batch records and reports to assure accuracy, completeness, and compliance with regulations, international standards, and company policies and procedures.

• Independently perform inspections and audits to monitor processes, facilities, equipment, personnel, materials, methods, practices, records, and controls to assure compliance with regulations and international standards.

• Participate in inspections and audits of subcontractors, vendors, and suppliers of products and services.

• Inspect materials and supplies for compliance with specifications.

• Assist in providing basic regulatory training to operations personnel.

• Assist in scheduling and tracking QA audits, inspections and procedures as requested.

• Maintain written records for all statistical sampling and testing of product if tested in manufacturing areas.

• Participate in manufacturing line clearances and verification of room acceptability prior to product manufacture.

• Participate in Regulatory Affairs and Compliance projects.

**Additional Requisition Requirements : **

QUALIFICATIONS

• Bachelors degree (B.A./B.S.) or equivalent, preferably in a life science or related discipline.

• Experience: 1-2 years' experience in QA role An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above. 

• Knowledge of Microsoft Office applications (e.g. Word, Access, Excel).

• Must be able to comprehend regulations and guidance documents and apply critical thinking skills to evaluate requirements

• Must be detail oriented and able to effectively communicate findings verbally and in writing.

• Expereince in GMP, Manufacturing, Laboratory