Operational Quality Specialist

The Operational QA Specialist provides Quality Assurance oversight for GMP manufacturing and support operations, including Upstream and Downstream Bulk Drug Substance (BDS) Manufacturing, Warehouse, Laboratories, and Facilities. This role is responsible for ensuring compliance with applicable regulatory requirements, internal quality standards, and site procedures while supporting the timely release of products and continuous improvement initiatives. Key Responsibilities Provide Quality Assurance oversight for GMP manufacturing operations, warehouse activities, laboratories, and facility support functions. Conduct routine area walkthroughs, rapid response activities, and process assessments to ensure compliance with GMP requirements. Review executed manufacturing batch records, including solution preparation and Bulk Drug Substance production records. Review and approve GMP documentation, including: Standard Operating Procedures (SOPs) Equipment logbooks Cleaning records Glass wash and autoclave records Facility and process documentation Review Environmental Monitoring (EM) and water system data to ensure compliance with established quality standards. Support investigations, deviations, CAPAs, and change control activities in partnership with QA leadership and cross-functional teams. Support internal audits, regulatory inspections, and inspection readiness activities by ensuring documentation is complete, accurate, and reviewed in a timely manner. Collaborate across multiple value streams to drive continuous improvement and strengthen the site's quality culture. Utilize and promote operational excellence tools and GPS standards, including: 5S Standard Work Problem Solving Gemba Walks Process Confirmation Performance Management Support organizational objectives focused on Zero Accidents, Zero Defects, and Zero Waste. Partner with cross-site and cross-functional teams to improve product disposition timelines and overall operational performance. Represent Quality Assurance on product teams, project teams, governance forums, and cross-functional working groups. Perform additional duties and special projects as assigned. Qualifications Bachelor's degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering, Pharmaceutical Sciences, or a related scientific discipline. Experience in Quality Assurance within a GMP-regulated pharmaceutical, biotechnology, or biologics manufacturing environment. Strong knowledge of cGMP regulations, quality systems, and regulatory requirements. Experience with deviations, CAPAs, change controls, investigations, and batch record review. Strong communication, collaboration, and problem-solving skills. Ability to work effectively in a fast-paced manufacturing environment and across multiple functional areas. Preferred Qualifications: Experience supporting biologics or cell culture manufacturing operations. Experience with regulatory inspections and audit readiness activities. Lean Manufacturing or Operational Excellence experience, including continuous improvement methodologies. Schedule: Wednesday to Saturday - 8PM - 6AM The anticipated salary range for this position in Maryland is $99,825 to $133,100 plus annual bonus, when eligible. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Benefits 13 paid holidays Vacation time 401K match Medical, dental and vision benefits effective day one of employment Samsung Biologics is a fully integrated CDMO offering state-of-the-art contract development and manufacturing services. With proven regulatory approvals, the largest capacity, and the fastest throughput, Samsung Biologics is an award-winning partner of choice and is uniquely able to support the development and manufacturing of biologics products at every stage of the process while meeting the evolving needs of biopharmaceutical companies worldwide. #J-18808-Ljbffr Samsung Biologics