QA Compliance Specialist


Job ID 17-00323

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.

REPORTING RELATIONSHIPS
This position reports to the Associate Director, Quality Assurance and Compliance and has no direct reports.

DUTIES & ESSENTIAL JOB FUNCTIONS
-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

OTHER FUNCTIONS AND RESPONSIBILITIES
-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.

REQUIRED
-A Bachelor's Degree in a scientific discipline
-Ability to travel 25% of the time.
-Excellent verbal and written communication skills in English.


PREFERRED
-ASQ Certification preferred but not required.