Sr QA Associate

Purpose & Scope:

Review and approve batch records, deviation investigations, and reports. Provide inter- and intradepartmental support in the preparation and review of documentation related to and including manufacturing processes, equipment, and computer systems that affect GMP-related activities.

Administers the QA deviation and CAPA system, internal audit system, supplier audit system, and all other necessary quality systems. Provides GMP guidance to other departments and project teams.

Essential Job Responsibilities:

• Assist in the investigation, reporting, and resolution of major deviations
• Review and approval of validation protocols and reports
• Review and approval of all GMP document revisions including SOP's, MPR's, specifications, test methods, etc.
• Administration of the deviation and CAPA system
• Administration of the internal audit and supplier audit program
• Performance of internal and external audits
• Host and support for audits of APT by third parties, Avara corporate, and all regulatory bodies
• Review and approval of CAPA plans and completion
• Follow up on CAPA and deviation to ensure effectiveness
• Representation of QA on site-wide and regional and global project teams
• Provide GMP guidance to all affected departments at APT
• Development and preparation of all QA metrics and reporting the results to APT and regional and global management (Q10)
• Development and administration of APT OJT and GMP training program
• Use of statistical analysis tools to evaluate data
• Development and use of risk assessment tools

Quantitative Dimensions:

This position has direct impact on batch processing and release, disposition of materials and components, approval and disposition of minor and major level deviations, the compliance state of APT, and site wide project support. This position has direct interaction with international regulatory agencies, APT suppliers and vendors, and other Avara affiliates and departments. This position has an indirect impact on Avara-wide compliance and other company-wide projects.

JOB DESCRIPTION

Organizational Context:

• Reports to the Manager of Quality Assurance
• No direct reports

Qualifications:

Required

• 3-5 years previous experience with GMP within the pharmaceutical industry
• 3-5 years direct QA experience
• Good verbal and written communication skills with basic computer skills.
• Attention to detail and accurate record keeping.
• Able to multi-task.
• Basic understanding and knowledge of GMPs and the pharmaceutical industry, quality practices and standards
• Experience with statistical data analysis preferred
• Must be able to read, write and understand the English language (statement common to all Job Descriptions)
• Must be able to work independently with some supervision.
• Must be able to gather and evaluate data to make sound decisions.
• Must be able to exercise judgment in the resolution of problems.
• Office environment; must be able to sit at a desk for extended periods of time.
• Occasionally requires ability to climb stairs and the ability to perform while wearing required personal protective equipment, such as respiratory protection, eye protection, hearing protection and safety shoes.
• Knowledge of CFR parts 210 &211
• Experience with Microsoft programs (Excel, Word, etc.)

Preferred

• Bachelor’s degree