Overview

Applicants invited to apply for Senior QA Associate I/II role in Quality assurance department. Reporting in the first instance to the QA Manager of Sterile Operations, the successful candidate will have the key responsibilities as outlined below.

Responsibilities

• Ensures compliance to internal procedures, policies, and standards, as well as all relevant State, Federal and International regulations during oversight of the operations.
• Approve complaints, change controls, deviations, CAPA, batch records, validation reports and other controlled documents
• Identifies compliance risks and develops sound rationale as basis for audit observations.
• Supports the coordination activities and assists with interactions during regulatory agency inspections
• Perform internal audits. 
• Participates in the review and revision of Compliance-related controlled documents

*Skills / Qualifications  *

• 6-8 years' experience in the pharmaceutical quality function for a Sr. QA Associate I
• 8+ years' experience in the pharmaceutical quality function for a Sr. QA Associate II
• Thorough knowledge of FDA and EU cGMPs and pharmaceutical manufacturing requirements
• Experience in quality systems for drug product manufacturing and quality control operations
• Experience in Pharmaceutical aseptic operations
• Project management experience including scheduling, tracking and auditing
• Technical expertise and understanding of cGMP sterile filling manufacturing processes
• Strong problem analysis (root cause analysis, risk assessment, and CAPA development) skills are preferred
• Experience in document and change control review/ approval and auditing
• Familiarity with Validation documentation, qualification of facilities, utilities, equipment and processes
• Ability to effectively plan, organize and prioritize work

Education

• Bachelor's degree in a scientific discipline or related field

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