QA Compliance Specialist

Job ID 18-00046

Industry Pharma

Job Type Permanent

Location Dayton, NJ

Description JOB SUMMARY

-Oversee Vendor Qualification Program
-Conduct External Audits of Suppliers, Contract Testing Labs, Contract Manufacturing and Packaging -Companies. Completion of audit
reports and follow up on observations in a timely manner.
-Ensure adherence to annual audit schedule. -Implementation of Quality Agreements. -Conduct Supplier Risk Assessments annually. -Completion of Vendor Assessment Forms. -Recertification of Suppliers and Vendors as per applicable procedures. -Responsible for Internal Audits -Create an internal audit schedule for the sites on an annual basis and ensure adherence to the schedule.
-Conduct internal audits of each functional area, write the reports in a timely manner and ensure observation responses are adequate and completed on time.
-Drive continuous improvement initiatives throughout the sites.
-Conduct Walkthroughs on a frequent basis to identify gaps and deficiencies.
-Participate in Regulatory Inspections and Customer Audits
-Scribe during regulatory inspections
-Provide compliance related support during inspections.
-Lead a proactive approach to regulatory inspection readiness.
-Active participation during customer visits and audits.
-Conduct training on industry trends related to ongoing compliance issues, regulatory trends and the implementation of new guidance's.
This position reports to the Associate Director, Quality Assurance and Compliance and has no direct reports.
50% - Monthly - Vendor Qualification
30% - Monthly - Internal Audits
10 % - Monthly - Regulatory and Customer Inspections
10% - Monthly - Any other tasks assigned by the Head of the Dept
Perform other duties as assigned

Qualifications QUALIFICATIONS 3 to 5 years of experience in the Pharmaceutical industry specifically in a QA & Compliance role. 4 year science degree from an accredited university. ASQ Certification preferred but not required. Strong knowledge of the Pharmaceutical Manufacturing process, particularly Oral Solids Manufacturing. R
A Bachelor's Degree in a scientific discipline
Ability to travel 25% of the time.
Excellent verbal and written communication skills in English.
ASQ Certification preferred but not required.