Job Title: Quality Assurance Senior Associate

Job Description

The Quality Assurance Senior Associate will work fully onsite in a shift-based role, partnering closely with manufacturing and support teams to oversee bulk drug substance production and new product introductions across development, clinical, and commercial operations. This plant quality assurance, on-the-floor position facilitates real-time decision making to ensure strict adherence to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and applicable regulations. The role offers a unique opportunity to strengthen collaboration between Manufacturing and Quality by providing coaching, guidance, and direction on manufacturing events, deviations, quality systems, and compliance.

Responsibilities

• Provide ongoing quality oversight to ensure products are manufactured, tested, stored, and distributed in accordance with cGMP, GDP, and other applicable regulations.
• Ensure that facilities, equipment, materials, organizational structures, processes, and procedures comply with applicable regulations and internal requirements related to Good Manufacturing Practices, Good Documentation Practices, safety, and other controls.
• Drive closure and completion of cGMP processes, procedures, documents, and records, including reviewing and approving deviations, investigations, and corrective and preventive actions (CAPAs).
• Verify that production and testing records and results are complete, accurate, and documented according to established procedures, GDP, and cGMP requirements.
• Oversee and provide guidance during on-the-floor analytical testing to ensure compliance with quality standards.
• Ensure that changes with potential impact on product quality are assessed and documented according to established procedures.
• Confirm that deviations from established procedures are properly investigated and documented in line with procedural requirements.
• Alert Senior leadership to quality, compliance, supply, and safety risks in a timely and clear manner.
• Provide project management support by leading efforts to achieve tasks on schedule and developing strategies for system implementation.
• Identify and implement continuous improvement opportunities within quality-related processes and systems.
• Support and represent plant quality assurance during audits and inspections, and directly interact with regulatory agencies during on-site inspections as needed.

Essential Skills

• Strong understanding and demonstrated behaviors aligned with current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).
• Experience working in a biotechnology or similarly highly regulated manufacturing environment.
• Knowledge and hands-on process experience within a cGMP manufacturing facility.
• Technical understanding of upstream and/or downstream manufacturing operations in biotechnology production.
• Proficiency with Microsoft Office applications.
• Experience with electronic systems such as Electronic Batch Records/Manufacturing Execution Systems (EBR/MES), DeltaV, and electronic quality systems.
• Ability to make real-time quality decisions on the manufacturing floor in alignment with regulatory and procedural requirements.
• Strong attention to detail and accuracy in reviewing and approving cGMP documentation, deviations, investigations, and CAPAs.
• Effective communication skills to provide guidance, coaching, and clear escalation of quality and compliance risks.

Additional Skills & Qualifications

• High school diploma or GED with at least 4 years of relevant work experience, or
• Associate degree with at least 2 years of relevant work experience, or
• Bachelor’s degree with at least 6 months of relevant work experience, or
• Master’s degree in a relevant field.
• Experience supporting audits and inspections, including direct interaction with regulatory agencies.
• Background in project management or leading implementation of quality or manufacturing systems.
• Demonstrated ability to identify and drive continuous improvement initiatives within quality or manufacturing processes.

Work Environment

This role is fully onsite in a plant manufacturing environment and follows a shift work schedule that includes weekends and may include night shifts. The specific shift will be determined during the hiring process, and once assigned, the schedule remains stable. The position is primarily on the manufacturing floor, working closely with production and analytical testing teams in a cGMP