Quality Assurance Analyst 1

Job Description

Primary responsibilities: 

Providing quality disposition on materials, performing product retention exams, and providing quality reviews of documentation at contract warehouse/distribution center. Interfacing directly with the contractor, the Candidate must be highly motivated and be able to work autonomously, requiring little supervision for most assignments. They must take initiative to identify and resolve product related issues and procedural deficiencies to improve productivity. Attend of routine meetings with Contractor ensure quality system alignment.

Other responsibilities include: Using compliance knowledge base and risk assessment capabilities to provide routine quality oversight of contractor, working directly with the Contractor, Third Party QA and the Supply Chain to assure rapid/appropriate response to quality related matters. Provides first response for Quality and Compliance issues noted at the Contract Warehouse, and escalation as appropriate. Providing the Contractor guidance regarding interpretation of Regulatory requirements. Performs incoming quality checks and batch release activities. Verifies transport conditions of incoming materials. Releases product for distribution. Prepares protocols for specials projects, supervises the protocol execution, and writes reports. Provides feedback for deviations and change controls. Conducts risk-based quality assessments and makes risk-based decisions for quality issues. Assist with resolving issues and initiating process improvements. Participates in product launches, site audits/inspections, as needed. Performs other duties as assigned.

Skills:

This candidate will also need to be flexible in their schedule as well as occasional weekends/off shifts will be required

3-5 years Pharmaceutical experience (including Quality/Compliance/Regulatory/Auditing experience) Experience in warehouse and distribution systems quality role preferred. The ideal candidate will have great customer service relations skills and pay close attention to detail and have overall quality focus.

Supervisory experience is a plus NOT required

Qualifications

Education:

Required: BS in Science/Pharmacy/ or related field

Additional Information

For more information, Please contact

Akriti Gupta

(973) 967-3409

Morristown, NJ 07960