Site QA Specialist

Job Description

Responsibilities include:

• The On-Site QA Specialist will be introduced to the on-site QA department and associated functions and responsibilities. The individual will have prior experience in a cGMP setting similar to the items outlined below. With guidance from management this role will be responsible for learning the process and steps required to perform all functions independently. It is the expectation that the On-Site QA Specialist will quickly learn to independently provide QA support to the organization as outlined below.

• Assists all departments in the identification and evaluation of facility events. Assures proper documentation is initiated to capture the event.

• Reviews executed batch records.

• Perform inspection and disposition of raw materials on the basis of approved specifications.

• Writes deviations, investigations, change controls and/or CAPAs.

• Performs shipping release procedures.

• Assists in the preparation of Annual Product Review documentation for all SPL Marketed Products.

• Administrative support for the on-site QA department such as generation of DCR's, file organization, data compilation, training activities, etc.

Job Requirements and Qualifications:

Education: Bachelor’s degree or above required; Bachelor’s degree or above in Scientific discipline preferred

Experience: 2 plus years of experience required; 5 plus years of experience preferred