Quality Assurance Specialist II

Job Summary

A Quality Assurance Specialist II will provide hands-on support for production and quality operations, ensuring product quality, regulatory compliance, and adherence to GMP requirements within a biopharmaceutical manufacturing environment.

Roles & Responsibilities

• Perform Quality Assurance activities including batch record review, line clearance, and on-the-floor production support.
• Provide QA oversight and approval of Quality Control activities, including method transfers, Certificates of Analysis (CoA), and stability data.
• Support and approve product shipments and packaging operations.
• Ensure timely review and closure of deviations, discrepancies, CAPAs, change controls, and laboratory investigations.
• Manage and resolve batch and material hold events in a timely manner.
• Communicate lot disposition status and pending issues to management.
• Conduct walkthroughs and process observations to ensure compliance with GMP standards.
• Provide real-time QA oversight to ensure manufacturing operations adhere to regulatory and quality requirements.
• Perform document control activities, including record archival and training documentation updates.
• Support regulatory inspections and audits, including preparation and execution support.
• Identify compliance risks and escalate issues as needed.
• Author and update SOPs, procedures, and forms.
• Perform additional duties as required to support quality and operational goals.

Education & Experience

• Relevant experience in quality assurance, quality control, or GMP manufacturing environments.
• Experience supporting deviation management, CAPA, and change control processes.
• Familiarity with batch record review, product release, and QA oversight activities.
• Experience working in regulated biopharmaceutical or life sciences environments.
• Background in analytical, virological, or microbiological Quality Control testing.
• Working knowledge of GMP standards aligned with U.S. and EU regulations.
• Experience with systems such as Veeva, Smartsheet, and LIMS.
• Bachelor's degree with 2+ years of experience, OR Master's degree, OR Associate degree with 4+ years of experience, OR High school diploma with 5+ years of relevant experience in biological sciences or a related field required.
• Strong understanding of GMP compliance and quality systems.
• Excellent attention to detail with a focus on accuracy and completeness.
• Strong organizational and time management skills.
• Effective communication and interpersonal skills in a collaborative environment.
• Ability to identify risks and proactively escalate issues.
• Strong problem-solving skills with the ability to manage complex quality scenarios.
• Flexibility to support weekend and off-hours work during manufacturing campaigns.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).