Quality Assurance Specialist (1083)

Description

Performs Quality Assurance activities and evaluates systems and processes to ensure compliance with regulatory requirements. Writes, reviews and maintains cGMP documents such as Standard Operating Procedures (SOPs) and Forms. Reviews and approves Batch Production Records (BPRs), Investigational Reports, validation documentation, and draft contract manufacturing documentation. Reviews, revises and processes product specification changes. Establishes and maintains cGMP compliant product storage facilities. Establishes and maintains an internal label control system. Performs internal audits within the pilot plant facility and may conduct investigations related to manufactured products. Reviews and approves documents such as Deviations, Change Controls, CAPAs, and OOSs. Performs QA related training and conducts meetings in support of EDMS, CRB and NCMR.

 Required Skills

Ability to discuss fundamental technical and regulatory issues within a multidisciplinary environment. Prior experience preparing, reviewing and submitting regulatory compliance documents. Excellent writing and communication skills. Ability to perform mathematical calculations involving fractions, decimals and percentages.

 Required Experience

Bachelor?s degree in Chemistry, Biochemistry, Microbiology, Immunology or related technical field preferred, with five to eight years of experience in the pharmaceutical, biotechnology or medical device industry. Minimum four years experience in FDA/CBER regulated industry.