Quality Assurance Specialist

Responsibilities

• Perform daily quality assessments of facilities, personnel practices, and documentation in both classified and non-classified areas to identify errors or deficiencies and ensure compliance with cGMP and site procedures.
• Interact daily with production employees to assist with troubleshooting process and equipment issues, correct and annotate documentation, and provide guidance on aseptic technique.
• Champion a strong quality culture by helping personnel understand and apply quality policies, procedures, and controls in their daily work.
• Participate in RAPID event responses and provide quality guidance during deviation events to support timely and compliant resolution.
• Advance deviation events to the appropriate operational area and quality management for further investigation and decision-making.
• Perform quality review and approval of procedures, training documents, and forms of moderate to high complexity to ensure clarity, accuracy, and compliance.
• Conduct quality review and approval of deviation records and change controls of moderate to high complexity, ensuring appropriate risk assessment and documentation.
• Serve as the quality assurance representative in Root Cause Analysis activities to support deviation investigations of moderate to high complexity.
• Identify opportunities for continuous improvement in processes and documentation, and actively participate in practical process improvement initiatives.
• Capture and analyze data related to process performance and equipment issues, collaborating with production leadership to troubleshoot and implement corrective actions.
• Support, lead, and empower peers and cross-functional teams to maintain high standards of quality and operational excellence.
• Prepare and contribute to technical writing activities, including quality-related reports, procedures, and investigation documentation.
• Maintain a consistent presence on the production floor, adhering to aseptic and non-aseptic gowning requirements while monitoring operations for quality and compliance.
• Follow all applicable safety practices, including the use of required personal protective equipment, while working in manufacturing and laboratory environments.

Requirements

• Bachelor’s degree, preferably in technology, engineering, microbiology, or a related scientific or technical field, or an equivalent combination of education, training, and relevant work experience.
• Minimum of 4 years of experience in Quality Assurance, Quality Control, or Operations/Manufacturing.
• Previous experience in the pharmaceutical industry, with a strong preference for aseptic or sterile processes; experience in other regulated environments such as ISO 9001 may be considered.
• Demonstrated ability to capture data, analyze results, and troubleshoot process issues and equipment problems in collaboration with production leadership.
• Prioritization of quality and operations with a hard-working and proactive approach.
• Strong sense of ownership and responsibility, with a hard-working and proactive approach to quality and operations.
• Technical writing experience, including preparation or review of procedures, reports, and quality documentation.
• Knowledge and application of cGMP principles and quality assurance practices in pharmaceutical or similarly regulated environments.
• Capability to perform primary responsibilities on the production floor, requiring physical fitness for prolonged standing, walking, repetitive bending, and aseptic and non-aseptic gowning.

Qualifications

• Professional certifications in quality, such as Certified Quality Auditor (CQA), are a plus.
• Training or experience in Six Sigma or other continuous improvement methodologies is advantageous.
• Experience with CAPA (Corrective and Preventive Action) processes and documentation.
• Familiarity with qualification activities in a cGMP environment.
• Strong interpersonal skills to effectively interact with cross-functional teams and production staff.
• Ability to promote and sustain a culture of quality and continuous improvement.
• Comfort working within structured quality systems, including GMP, QA, and related regulatory frameworks.

Skills

• Ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Strong sense of ownership and responsibility, with a hard-working and proactive approach to quality and operations.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Strong sense of ownership and responsibility, with a hard-working and proactive approach to quality and operations.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing