Quality Assurance Specialist

Job Title: Quality Assurance Specialist Job Description The Quality Assurance Specialist plays a key role in ensuring the accuracy, completeness, and compliance of batch records for sterile medical products. This position focuses on detailed review of both electronic and paper batch records, verification of manufacturing processes, and support of quality systems to meet regulatory and internal quality standards. The role requires strong attention to detail, critical thinking, and the ability to work effectively in a fast-paced, highly regulated environment. Responsibilities Review approximately three batch records per day, with emphasis on accuracy, completeness, and compliance rather than volume. Perform detailed batch record reviews for both electronic and paper-based records to ensure they meet established procedures and specifications. Review data and manufacturing process verifications to ensure compliance with operating procedures and product specifications. Review in-process control samples, organize them, and ensure they are properly prepared and transferred according to procedures. Provide support for quality activities, including initiating and supplying supporting data for the resolution of quality issues. Provide quality oversight over the Quality System, including review of reports, data (including metadata), and records that support the manufacturing and distribution of products. Conduct timely quality reviews of associated data, including data used to support batch release, to meet business and operational timelines. Assist in complying with regulatory requirements related to product safety and quality, including applicable standards and guidelines. Ensure procedures are followed in alignment with FDA, ICH, standard methods, and internal Quality System requirements. Review records to ensure data meets industry requirements for data integrity, including completeness, consistency, and accuracy. Communicate clearly with cross-functional teams to clarify discrepancies, ask questions, and resolve issues identified during review. Work under general supervision while exercising sound judgment in resolving routine problems and escalating complex issues as needed. Essential Skills At least 2–3 years of hands-on batch record reviewing experience, with emphasis on quality and accuracy. Bachelor’s degree in a science discipline. 5–6 years of overall relevant experience in a quality-focused role within medical device, pharmaceutical, or similar regulated environments. Strong quality assurance experience in document control and batch record review. Experience supporting corrective action plans and validation activities related to quality and manufacturing processes. Ability to work under general supervision and use sound judgment to resolve routine problems. Strong attention to detail with the ability to identify discrepancies and data integrity issues. Excellent communication skills, both written and verbal, to document findings and collaborate with team members. Strong critical thinking skills to analyze data, interpret requirements, and make informed decisions. Ability to stay organized and maintain accuracy in a fast-paced and sometimes stressful work environment. Reliable and predictable on-site attendance during assigned shifts. Additional Skills & Qualifications Experience with Labware in a GMP environment, particularly in relation to batch record reviewing and data review, is highly desirable. Experience working with Manufacturing Execution Systems (MES) to review process data and electronic records is a plus. Experience in medical device or pharmaceutical manufacturing environments. Experience reviewing microbiological and chemical data generated by laboratory teams. Familiarity with FDA, ICH, and industry-standard methods and expectations for data integrity. Confidence to ask questions, seek clarification, and work independently when appropriate. Ability to support quality investigations and contribute to the resolution of quality issues. Work Environment This is an on-site role in a dynamic, fast-paced environment that supports the manufacture of sterile saline and syringe products for hospitals and clinics. The primary shift is Monday through Friday, typically 8:00 a.m. to 5:00 p.m., with some flexibility; some team members start as early as 5:30 a.m. The work involves extended periods of detailed document and data review, requiring sustained concentration and accuracy. The facility operates under Good Manufacturing Practice (GMP) standards and follows strict quality and