Quality Assurance Specialist

This role provides day-to-day technical, quality, and operational support to pharmaceutical manufacturing operations. The Quality Assurance Specialist ensures production activities comply with cGMP standards, regulatory expectations, and safety requirements while supporting efficient, high-quality output in a fast-paced, highly regulated environment.

Responsibilities

• Provide floor-level technical support to manufacturing operators and supervisors during 3rd shift operations.
• Troubleshoot equipment issues, process deviations, and workflow bottlenecks to maintain consistent production performance.
• Monitor production activities and assist with implementing corrective and preventive actions to address quality and operational concerns.
• Prepare, revise, and maintain GMP documentation, including standard operating procedures (SOPs), batch records, and logbooks.
• Ensure adherence to FDA and other global regulatory requirements across all manufacturing processes.
• Support investigations, develop CAPAs, and participate in change control processes to drive continuous improvement and compliance.
• Perform data collection, review, and analysis to verify compliance with cGMP and to identify opportunities for process optimization.
• Partner with Process Control teams to support equipment qualification and validation activities.
• Assist with process improvements, optimization initiatives, and technology transfers within manufacturing operations.
• Support coordination of preventive and corrective maintenance activities with Engineering and Maintenance departments.
• Train manufacturing personnel on procedures, new equipment, and process changes to promote consistent and compliant operations.
• Act as a subject matter liaison between Production, Quality, and Maintenance teams to ensure alignment on quality and operational standards.
• Uphold and promote a strong culture of safety and compliance on the production floor and within controlled environments.
• Support environmental monitoring and compliance activities as needed to maintain cleanroom and controlled area standards.
• Perform quality checks, inspections, and audit-related activities to verify product and process conformance to established specifications.

Requirements

• 1–3+ years of experience in pharmaceutical, biotech, or other regulated manufacturing environments.
• Working knowledge of cGMP, GDP, and applicable regulatory guidelines.
• Strong analytical and problem-solving skills for technical troubleshooting and issue resolution.
• Excellent communication skills for clear interaction with cross-functional teams and documentation of activities.
• Strong documentation skills for accurate completion and maintenance of GMP records and reports.
• Ability to work effectively in a fast-paced, highly regulated manufacturing environment.
• Demonstrated attention to detail and accuracy in all quality-related tasks.
• Technical troubleshooting capabilities for equipment, process, and workflow issues.
• Collaboration and cross-functional communication skills to work effectively with Production, Quality, Engineering, and Maintenance.
• Effective time management and prioritization skills to handle multiple tasks and shifting priorities.
• Continuous improvement mindset focused on enhancing quality, efficiency, and compliance.
• Strong compliance and quality focus, with commitment to regulatory and safety standards.
• Experience with quality assurance, quality control, quality checks, inspection, and environmental monitoring.

Qualifications

• Experience in sterile or aseptic operations and biologics manufacturing is preferred.
• Knowledge of Six Sigma or other continuous improvement methodologies is an advantage.
• Familiarity with batch records, inventory management systems, and laboratory information management systems (LIMS) is beneficial.
• Experience supporting audits and participating in quality-related inspections.
• Ability to train and coach manufacturing personnel on procedures and process changes.
• Comfort working in cleanrooms and controlled environments with strict compliance requirements.

Work Environment

This role is primarily on-site in pharmaceutical manufacturing areas, including cleanrooms and controlled environments that require appropriate gowning in classified areas. The position supports 3rd shift operations and works within a highly regulated, safety-focused setting that emphasizes compliance with cGMP and regulatory standards.

Typical production schedules follow extended shifts, with standard hours for 1st shift noted as 6:00 AM to 4:30 PM over four 10-hour days. Availability may be required on various days of the week and for a 5-day schedule as indicated. The work involves close collaboration with Production, Quality, Engineering, Maintenance, and Process Control teams, frequent interaction with manufacturing equipment and monitoring systems, and adherence to cleanroom protocols and documentation requirements.

Pay

The pay range for this position is $52,000.00 - $62,400.00 per year.

Benefits

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Parental leave
• Referral program
• Tuition reimbursement
• Vision insurance

This is a permanent, fully onsite position based in Syracuse, NY.