QA Associate

Quality Assurance Associate

Join a team dedicated to quality, compliance, and clinical trial excellence to make a meaningful impact in the pharmaceutical industry. This role supports quality assurance activities and ensures compliance with EU GMP/GDP standards. You will work closely with internal teams and external stakeholders to maintain high-quality standards in pharmaceutical operations, playing a key role in supporting clinical trials and ensuring the integrity of processes and documentation.

Key Responsibilities

• Assist the Qualified Person in preparing QP Declarations and Certificates, including supply chain diagrams, product specification files, and regulatory document reviews.
• Participate in client and departmental meetings.
• Support recall processes by gathering information, preparing documentation, and performing accountability checks.
• Generate, revise, and review Standard Operating Procedures (SOPs), Data Capture Forms, and other GMP/GDP documents.
• Manage SOPs, forms, work instructions, and training materials within electronic systems.
• Conduct internal SOP training, track employee training, and maintain training records.
• Create and deliver periodic GXP training sessions.
• Perform or participate in internal, supplier, client, and regulatory audits.
• Review and archive preventative maintenance documentation.
• Manage instrument calibration, maintenance, and related investigations.
• Maintain GMP/GDP documentation, including scanning, filing, and archiving.
• Provide QA support for GMP/GDP activities such as receiving, storing, distributing, and processing products.
• Conduct incoming quality control inspections and packaging room activities as needed.
• Verify returns for accountability and oversee inventory control system data entry.
• Approve material specifications and batch record-related documents.
• Release products and clinical labels, monitor expiration dates, and authorize material destruction.
• Review logbooks weekly and investigate operational discrepancies and complaints.
• Maintain supplier approval records and support CAPA program development and tracking.
• Ensure proper change control procedures for documentation and systems.
• Oversee GMP/GDP risk assessments and validation activities.
• Generate quality metrics and review new products for handling suitability.
• Approve packing configurations and qualification reports for insulated shipping containers.
• Review and approve materials for interoffice shipping requests.

Key Skills and Requirements

• Strong understanding of GMP and GDP standards in the pharmaceutical industry.
• Familiarity with GCP in clinical trials.
• Excellent communication, reading, writing, and problem-solving skills.
• Proficiency in computer literacy and attention to detail.
• Effective time management and adaptability to changing workloads and deadlines.
• Ability to work collaboratively in a diverse team environment.
• Experience in a GMP environment supporting global clinical trials.
• Previous QA manufacturing support experience, particularly with sterile, biotech, or vaccine products.
• Bachelor's degree or equivalent in a relevant field.