Quality Assurance Associate II

Quality Assurance Associate II

Requirements

• Bachelor’s degree with any years of experience, or an Associate’s degree with 4 years of relevant experience, or a high school diploma (or equivalent) and 6 years of relevant experience
• Experience in the pharmaceutical industry and Quality administered systems
• Sound knowledge of current Good Manufacturing Practices (part of GxP)
• Ability to work effectively in a team environment, both within one’s own team and interdepartmental teams
• Effective written and oral communication skills
• Ability to manage day-to-day workload with minimal oversight
• Basic knowledge of continuous improvement principles and practices
• Excellent written and oral communication skills
• Highly organized and detail oriented

Responsibilities

• Evaluate and review clinical and commercial drug batches to ensure quality
• Issue and reconcile GMP forms and logbooks
• Execute on defined and established procedures, work instructions and templates
• Process documents in Electronic Document Management System (EDMS)
• Maintain and distribute documents to Controlled Document Locations (CDLs)
• Identify and address deviations from manufacturing and packaging standards
• Manage the Records Management Job function, archiving and off-site storage process
• Responsible for receiving and logging GMP records, cataloging, physical or electronic filing, and retrieval as needed
• Work with GMP personnel submitting and retrieving records to ensure records are maintained and tracked in compliant manner and are readily available
• Scans and digitizes GMP records and verifies as true copies
• Participates in cross-functional teams to implement, update, or upgrade systems or processes related to the management of GMP records. Collects and assists with reporting on relevant metrics
• Contribute to project tasks and milestones, organizing work to meet deadlines
• Learn and apply basic team effectiveness skills within the immediate work team
• Make decisions within limited options to resolve basic problems under supervisor’s direction
• Ensure manufacturing and packaging records conform to Pfizer policy and cGMP standards
• Maintain inspection readiness, support regulatory and customer inspections, and improve quality assurance systems
• Assist manufacturing/packaging staff in real-time compliance error detection and resolution, and lead or participate in Quality Risk Management assessments
• Participates in continual improvement activities within Document Control and GMP Records management

Preferred Qualifications

• Experience at a cGMP manufacturing site
• Managing and writing deviations
• Experience in production batch record review, Enterprise Resource Planning system, investigation of non-conformance, root cause analysis and change control management
• Strong problem-solving skills
• Ability to work independently and as part of a team
• Excellent time management and multitasking abilities