Preferred skills/knowledge in any of the following:

• Analytical Testing
• Laboratory OOS
• Validation Review/Approval
• Change Control Review/Approval
• Deviation Review/Approval

Purpose & Scope:

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. Review and approval of batch records.

Essential Job Responsibilities:

• Validation/Protocol documentation review and approval
• Laboratory OOS review and approval
• Site Change Control review and approval
• Assists in the investigation, reporting, and resolution of minor deviations
• Provide cGMP Training as required
• Product complaint Investigation
• Preparation of QA metrics
• Preparation of specimen samples of all packaging components and artwork
• Performance of QA line clearances and on-the-floor inspections
• Administration of ZenQMS Training Management System
• Review and approval of executed batch records and all records in support of batch release
• Participation in QA internal audit program
• Represent QA on sitewide project teams

Quantitative Dimensions:

This position has direct impact on batch processing and release, disposition of materials and components, and approval and disposition of minor level deviations. This position has indirect impact on the compliance state of APT, interaction with international regulatory agencies, and site wide project support.

Organizational Context:

• Reports to Manager Quality Assurance or Supervisor Quality Assurance
• No direct reports

Qualifications:

• Bachelor’s degree or 3 years pharmaceutical experience/applicable 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
• 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 judgement 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

• Previous experience with GMP within the pharmaceutical industry preferred.