Quality Assurance Associate

Role Summary

Quality Assurance Associate at Pfizer. Responsible for maintaining GMP records, document control, and supporting quality systems to ensure compliant, retrievable documentation and ongoing process improvement within GMP records management and related activities.

Responsibilities

• Execute on defined and established procedures, work instructions and templates
• Process documents in electronic Document Management System
• Answer basic questions and send routine notifications
• Issue and reconcile batch records, forms, and logbooks
• Maintain and distribute documents to Controlled Document Locations
• Back-up the Records Management job function as required
• 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 a compliant manner and are readily retrievable
• Participate in cross-functional teams to implement, update, or upgrade systems or processes related to the management of GMP records
• Support GMP regulatory audits and inspections ensuring timely retrieval of both physical and electronic records
• Scan and digitize GMP records and verify as true copies
• Perform reconciliation of completed records issued for GMP activities
• Collect and assist with reporting on relevant metrics
• Work with off-site storage facilities to ensure compliant submission and retrieval of GMP records
• Contribute to milestones related to specific projects
• Participate in continual improvement activities within Document Control and GMP Records management

Qualifications

• Required: Bachelor's degree with any years of experience, or an Associate's degree with 3 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

Preferred Qualifications

• Experience at a manufacturing site
• Managing and writing deviations, Change Control and CAPA
• Experience in production batch record issuance, reconciliation, 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

Education

• Not specified beyond the minimum requirements listed in Qualifications

Additional Requirements

• Work Location: On Premise