Senior Quality Assurance Associate

Job Description:

• Bachelors or Master’s degree in a scientific discipline or relevant equivalent knowledge and experience
• 10+ years Quality Assurance experience in a GMP manufacturing environment or equivalent experience
• Six Sigma or ASQ certification preferred

Knowledge/Skills Requirements:
• Use existing procedures and established literature to solve routine and non-routine problems
• Utilize all elements of the quality system to identify, classify and control the status of finished products produced
• Based on broad technical skills and QA experience, anticipates and identifies unmet customer needs
• Proactive to address work issues at the individual, team and department level
• Ability to follow and provide a variety of instructions furnished in written, oral, diagram or schedule form
• Ability to identify and provide guidance/mitigation for aberrant data and potential quality/compliance concerns escalating to management
• Lead by example according to Company’s values and culture
• Able to lead difficult discussions with customers and drive them to an acceptable resolution
• Provides reliable/defendable interpretations of regulatory guidance for the customer and is capable of defending these positions to regulatory agencies
• Ability to collaborate with peers and demonstrate leadership capabilities in a matrix environment.

The San Diego Clinical and Specialty Services (CSS) Quality Assurance Senior Specialist supports clinical trial projects, ensuring all work is performed in compliance with regulatory requirements, good manufacturing practices (cGMP) and standard operating procedures (SOPs). The Senior Specialist provides regulatory expertise to the investigation and deviation management process. Participates in and maintains site audit readiness by working closely with all departments within the business unit. They ensure that testing methods are validated, equipment is calibrated, and results are accurate and reliable.

• Ensures that products are manufactured, packaged, tested and released
• Performs document generation and review
• Participates in CI projects with risk-based approach
• Ensures that products are manufactured, packaged, tested and released according to applicable procedures
• Perform product release applicable procedures
• Lead investigator for deviations and complaints
• Performs document generation and review
• Participates in CI projects with risk-based approach
• Support functions associated with the packaging of clinical and commercial drug material
• Perform batch record review
• Participates in CI projects with risk-based approach
• Lead investigator for deviations and complaints
• Performs in-process audits, line clearance, verification of line clearance.
• Performs shipment verification
• Assesses incoming damaged material
• Participate in document generation and review
• Performs annual retain inspections
• Lead investigator for deviations and complaints
• Participates in CI projects with risk-based approach
• Reviews/approves model protocol, randomizations
• Performs label approval, print requests, label release
• Participates in document generation and review
• Lead investigator for deviations and complaints
• Tracks metrics for label control.
• Participates in CI projects with risk-based approach
• Reviews and tracks investigations/ deviations and corrective actions
• Participating in reported incidents to support quality compliance and business needs
• Assist in data compilation and management support of client business and quality review meetings
• Participates in CI projects with risk-based approach