Quality Assurance Specialist - Pharmaceuticals

Quality Assurance Specialist

The Quality Assurance Specialist provides hands-on quality support focused on Document Control, Learning Management System (LMS) administration and training delivery, on-the-floor QA oversight, and deviation/CAPA investigation and approval support. This role will start at the building stage that helps establish and maintain core quality processes, documentation, and training as the site advances toward routine GMP operations for Oral Solid Dosage (OSD) and related manufacturing, and transitioned to system maintenance and improvement after project go-live.

The Associate works with limited precedent, exercises independent judgment on quality issues of moderate to diverse scope, and partners closely with manufacturing and operations to embed Right First Time practices.

Document Control

• Own and execute document control activities within the electronic document management system (e.g., Veeva Vault), including drafting, reviewing, routing, approving, issuing, revising, and retiring controlled documents (SOPs, work instructions, forms, job aids, and related quality documentation).
• Ensure documents meet Good Documentation Practices, data-integrity (ALCOA+) expectations, and applicable GMP requirements.
• Maintain document hierarchies, version control, training linkages, and archival in accordance with site procedures.
• Support document change control processes and periodic review schedules.

Learning Management & Training

• Administer and support the Learning Management System (LMS), including curriculum assignment, training record maintenance, completion tracking, and reporting.
• Develop, revise, and deliver GMP, quality-system, and job-specific training materials and sessions for operations and quality personnel.
• Coach colleagues on quality principles and Right First Time behaviors; track training effectiveness and identify gaps.
• Ensure training is completed prior to task performance and that training records are complete, accurate, and inspection-ready.

On-the-Floor QA Oversight

• Provide independent, real-time on-the-floor quality assurance support to manufacturing and operations, including presence during production activities, line clearance, and process monitoring.
• Perform real-time or near-real-time batch record review and support timely resolution of quality issues arising during manufacturing.
• Conduct readiness checks and release of manufacturing areas, equipment, and processes; identify and escalate quality risks.
• Partner with manufacturing, engineering, and other functions to integrate quality requirements into daily operations and promote Right First Time execution.

Deviation / CAPA Investigation & Approval Support

• Support ownership and management of quality events, including deviations, investigations, root-cause analysis, CAPAs, and effectiveness checks.
• Assist in drafting, reviewing, and approving investigation reports and CAPA plans using structured problem-solving approaches.
• Track deviation/CAPA metrics, ensure timely closure, and support effectiveness verification.
• Escalate significant or recurring issues and contribute to trend analysis and continuous improvement.

Additional Responsibilities

• Support internal, client, and regulatory inspections as needed (including document retrieval and subject-matter support).
• Maintain accurate, contemporaneous records consistent with GDP and ALCOA+ principles across electronic quality and document systems.
• Contribute to continuous improvement of document control, training, and quality-event processes as the site quality system matures.

Required

• Bachelor's degree in a scientific, technical, or related discipline, or equivalent combination of education and relevant experience.
• At least 2-3 years of pharmaceutical or biopharmaceutical quality assurance or quality systems experience, including hands-on GMP manufacturing environment exposure.
• Demonstrated experience with Document Control processes and electronic document management systems (experience with Veeva Vault strongly preferred).
• Experience supporting or administering a Learning Management System (LMS) and delivering or coordinating GMP/quality training.
• Hands-on…