Quality Assurance Specialist

Job Responsibilities: 
• Maintain a Quality Assurance presence and verify incoming pharmaceutical shipments and materials against purchase orders, specifications, and receiving documentation in accordance with company standard operating procedures (SOPs). Review and approve documentation including, but not limited to, logbooks, material packets, specifications, packing lists, work orders, and procedures.
• Collaborate with Supply Chain, Quality Control, and Operations teams to investigate and resolve inventory, material, consumable, or component-related deviations.
• Support QA personnel and Operations with batch record reviews, documentation corrections, and production floor activities as needed.
• Inspect incoming materials and products for damage, discrepancies, or expiration and report any issues to management.
• Balance multiple priorities while ensuring compliance with timelines and quality requirements.
• Exercise sound judgment in evaluating the scope and impact of deviations, determining product segregation needs, and initiating or escalating corrective actions.
• Contribute to deviation investigations using root cause analysis and risk-based problem-solving tools; assist with documentation, report writing, and mitigation planning.
• Provide Quality Assurance oversight for material picking and Bill of Materials (BOM) verification.
• Support Supply Chain Management with critical alarm notifications related to storage equipment, such as freezers or incubators.
• Perform provisional and final material releases, as well as reject disposal activities following batch disposition.
• Promote safety and compliance by practicing proactive safety measures, positive intervention, and adherence to SOPs and regulatory standards.
• Assist with material transfer counts for both incoming and outgoing goods.
• Utilize paper-based and electronic systems (e.g., document control, building monitoring, maintenance management, or laboratory information systems) to ensure data integrity and accurate recordkeeping.
• Apply technical knowledge and statistical methods to analyze deviations, identify variability, and drive continuous improvement in site processes.
• Provide QA oversight of inventory cycle counts and investigate any discrepancies.
• Manage multiple priorities in a fast-paced manufacturing environment.
• Maintain accurate documentation and support preparation for regulatory inspections and audits.

Qualifications:
• Bachelor’s degree required, preferably in Logistics, Supply Chain, Management, Biology, or Chemistry,.
• Minimum of 4 years of experience in a GMP manufacturing environment, with exposure to quality operations, raw material/component release, or pharmaceutical supply chain/warehouse activities.
• Working knowledge of quality systems and regulatory frameworks, including deviations, non-conformances, and CAPA processes.
• Strong understanding of Good Documentation Practices (GDPs).
• Ability to obtain certification for operation of powered industrial equipment.
• Proficient in standard office and analytical software tools (e.g., Word, Excel, Visio, JMP, Minitab) and experience with inventory or quality management systems.
• Hands-on experience with aseptic manufacturing, finished product inspection, or warehouse and supply chain operations.
• Familiarity with continuous improvement methodologies, including Lean, Six Sigma, or related principles.