Quality Assurance Supervisor

QUALITY ASSURANCE SUPERVISOR

An integrated Pharmaceutical Packaging and Distribution company is seeking a Quality Assurance Supervisor in their upcoming facility at Hamilton Township, New Jersey.  The successful candidate will play a key role in creating Quality system and documentations confirming to 21CFR part 11.

JOB REQUIREMENT

• Create and establish a scientific approach to the company quality system.

• Perform sampling and release of bulk products in support of Packaging.

• Establish training and audit programs, as well as the review of SOPs, investigations, specifications, methods, validation reports, cleaning verification reports, analytical reports and Batch records.

• Review and approve Master documents such as Master Batch Packaging Records, In-process forms, Method Qualification Protocols, Method Validation Protocols, test methods, reference standards and other related documents.

• Provides guidance and training for other Quality Assurance staff in the accomplishment of Quality Assurance operation activities.

• Act as company’s representative during regulatory agencies and customer inspections.

QUALIFICATIONS

• BS degree in Chemistry, Life Science or related discipline and a minimum 3– 5 years of Quality Assurance experience in an FDA regulatory industry.

• Familiar to solid dosage pharmaceutical manufacturing and Packaging process with thorough understanding in GMP.

• Strong technical writing skills and the ability to clearly express ideas in English.

• Local Candidates preferred.