Quality Assurance Associate

Role Summary

Quality Assurance Associate

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
• Works with GMP personnel submitting and retrieving records to ensure records are maintained and tracked in a compliant manner and are readily retrievable.
• Participates in cross-functional teams to implement, update, or upgrade systems or processes related to the management of GMP records.
• Supports GMP regulatory audits and inspections ensuring timely retrieval of both physical and electronic records.
• Scans and digitizes GMP records and verifies as true copies.
• Performed reconciliation of completed records issued for GMP activities.
• Collects and assists with reporting on relevant metrics.
• Works with off-site storage facilities to ensure compliant submission and retrieval of GMP records.
• Contribute to milestones related to specific projects.
• Participates 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

Skills

• Experience at a manufacturing site (Preferred)
• Managing and writing deviations, Change Control and CAPA (Preferred)
• Experience in production batch record issuance, reconciliation, investigation of non-conformance, root cause analysis and change control management (Preferred)
• Strong problem-solving skills (Preferred)
• Ability to work independently and as part of a team (Preferred)
• Excellent time management and multitasking abilities (Preferred)

Education

• As listed in Qualifications (Bachelor's/Associate's/high school with experience)

Additional Requirements

• Work Location Assignment: On Premise