Quality Assurance Specialist

Job Title: Quality Assurance Specialist The Quality Assurance Specialist provides day‑to‑day technical, quality, and operational support to pharmaceutical manufacturing operations. This role ensures that all production activities comply with cGMP standards, regulatory expectations, and safety requirements while supporting efficient, consistent, and high‑quality output. The specialist works closely with cross‑functional teams on the production floor to troubleshoot issues, maintain compliant documentation, and drive continuous improvement across processes and equipment. Responsibilities Provide floor‑level technical support to manufacturing operators and supervisors to ensure smooth and compliant production activities. Troubleshoot equipment issues, process deviations, and workflow bottlenecks to minimize downtime and maintain product quality. Monitor production performance 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, logbooks, and related quality records. Ensure adherence to FDA and other global regulatory requirements by supporting daily operations and documentation practices. Support investigations into deviations and non‑conformances, assist with CAPA development, and participate in change control processes. Perform data collection, analysis, and review to support compliance, trend monitoring, and continuous improvement initiatives. Partner with process control teams to support equipment qualification and validation activities in accordance with regulatory and internal standards. Assist with process improvements, optimization initiatives, and technology transfers to enhance efficiency and product quality. Support coordination of preventive and corrective maintenance activities with Engineering and Maintenance departments to maintain equipment reliability. Train manufacturing personnel on procedures, new equipment, and process changes to ensure consistent understanding and execution. Act as a subject matter liaison between Production, Quality, and Maintenance teams to facilitate clear communication and alignment. Communicate production issues, progress updates, and risks to leadership in a timely and accurate manner. Uphold and promote a strong culture of safety and compliance on the production floor, reinforcing best practices and expectations. Participate in internal and external audits, walkthroughs, and safety reviews to support inspection readiness and continuous improvement. Support environmental monitoring and compliance activities as needed to maintain controlled manufacturing environments. Perform quality assurance activities such as in‑process quality checks, inspections, and oversight of quality control practices. Contribute to audit preparation and response efforts to ensure quality systems and processes remain robust and inspection‑ready. Essential Skills 1–3+ years of experience in a pharmaceutical, biotech, or other regulated manufacturing environment. Working knowledge of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP). Understanding of applicable regulatory guidelines and expectations for regulated manufacturing. Strong analytical and problem‑solving skills with the ability to troubleshoot technical and process issues. Excellent communication skills, both written and verbal, to support documentation, training, and cross‑functional collaboration. Strong documentation skills with attention to accuracy, completeness, and compliance. Demonstrated ability to work effectively in a fast‑paced, highly regulated environment. Experience supporting quality assurance activities such as quality checks, inspections, and audits. Familiarity with environmental monitoring and quality control concepts in manufacturing settings. High attention to detail and accuracy in all aspects of work. Technical troubleshooting skills related to processes, equipment, and production workflows. Strong collaboration and cross‑functional communication skills to work with Production, Quality, Engineering, and Maintenance teams. Effective time management and prioritization skills to handle multiple tasks and deadlines. A continuous improvement mindset with a strong focus on compliance and quality. Additional Skills & Qualifications Experience in sterile or aseptic operations and biologics manufacturing. Knowledge of Six Sigma or other continuous improvement methodologies. Familiarity with batch records, inventory management systems, and Laboratory Information Management Systems (LIMS). Experience participating in or supporting internal and external audits. In quality assurance, including quality control, quality checks, and inspection activities. Exposure to environmental monitoring programs within cleanroom or controlled environments. Ability to serve as a trainer for manufacturing personnel on procedures, equipment, and process changes. Comfort working with cross‑functional teams to support equipment qualification, validation, and process optimization. Work Environment This role is primarily on‑site within pharmaceutical manufacturing areas, including cleanrooms and other controlled environments. Work in classified areas requires appropriate gowning and adherence to strict hygiene and contamination control procedures. The typical first‑shift production schedule consists of four 10‑hour days, with standard hours from 6:00 AM to 4:30 PM. Candidates must be available for various days of the week and may be scheduled on a 5‑day workweek as needed. Occasional off‑shift or weekend support may be required during critical operations. The environment is highly regulated and safety‑focused, with close collaboration between Production, Quality, Engineering, and Maintenance teams and regular use of GMP documentation, electronic systems, and monitoring tools. Job Type & Location Permanent position based out of Syracuse, NY. Pay and Benefits The pay range for this position is $52,000.00–$62,400.00/yr. Benefits Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan – Pre‑tax and Roth post‑tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long‑term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type Fully onsite position in Syracuse, NY. Application Deadline This position is anticipated to close on Aug3, 2026. Equal Opportunity Employer Statement The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. Accommodations If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interview process due to a disability, please View email address on click.appcast.io for other accommodation options. Legal Notices San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records. Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. #J-18808-Ljbffr