Senior Operational Quality Specialist
• The purpose of this role is to be the first line of contact for operational quality advice and support for Production and other site operational areas. Drive for early detection and help prevent potential quality issues.
• Review of Batch Records for product that is manufactured in compliance with regulatory agencies’ requirements and company standards.
• Provides a Quality Oversight for the production areas including Manufacturing, Warehouse, Laboratories, Facilities and Engineering.
• Perform rapid response, walk thrus, process assessments, and change over walk-thrus
• Review GMP related documentation such as SOPs, MC, Deviation/CAPAs, executed solution batch records and executed BDS process batch records Master Batch Records, Glass Wash and Autoclave records, cleaning logs, temperature charts, equipment alarms and Technical Reports. Approves any changes associated with these documents.
• Review EM and water data for facility and EM for bulk fills
• Review executed protocols and summary reports for GMP laboratory equipment, manufacturing equipment, facility utilities, process controllers, IT systems and process validation
• Support change control oversight under the supervision of Sr. QA Specialist
• Support/Perform L1 and L2 audits and Inspection Readiness efforts making sure that area logbook and documentation is accurate and review in a timely manner
• Review Validations documents.
• Work across multiple value streams to drive continuous improvement and promote quality culture. Utilizes and continuously improves the GPS standards (i.e. 5s, standard work, problem solving, Gemba, process confirmations, and performance management) towards the goal of Zero Accidents, Zero Defects, and Zero Waste
• Work closely with cross site teams to drive performance of product disposition.
• Represent QA on product/project teams, in work group meetings, participate in facility design teams and specific drug product development teams
• Performs other functions as necessary or as assigned.
Addition for Senior
• Participate on product related teams as required to provide QA validation Impact assessments and provide compliance related input as needed
• Perform BDS release activities and interact with secondary site QPs to support DP dispositions
• Lead training sessions
• Facilitate, coach and mentor teams and individuals to build site capability in the RCA and CAPA processes
• Review deviations, CAPAs and Change Controls
• Support validation including review of protocol deviations
• Review and Approve Operational Procedures
Knowledge/ Education / Previous Experience Required:
• Minimum, 4 years degree (BS) in Technical/Scientific discipline
• 3+ years relevant experience or equivalent combination of education and experience.
• Knowledge of cGMP’s/FDA and other Regulatory requirements such as ICH Guidelines 8, 9, 10, 11.
• Demonstrate initiative and analytical problem solving skills – ability to use and interpret data to drive decision making at both tactical and strategic level.
• Ability to work well under high pressure and deadlines
• Must be flexible, adaptable, and a strong team player and a leader that fosters teamwork and promotes The Company's Values, Behaviors and Strategies.
• Excellent verbal and written communication skills required.
• Conflict resolution and interaction management skills required.
• Knowledge and application of the principles of Quality Management Systems (QMS)
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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