In support of the Quality Control organization at LSNE the incumbent is responsible for leading quality systems activities in support of Environmental Excursions, Out-of-Specification, Deviation, CAPA and Change Control records for the Quality Control organization at LSNE. Additional areas of responsibility include but are not limited to audit support (inspection readiness), Method Validation Support and QC data review / trending.
JOB DUTIES - Lead Support / Investigator for EEIs, OOSs, Deviations, Change Controls, CAPAs, and other QC related investigations.Provides technical subject matter expertise (SME) in support of investigationsCollaborates with peers / cross-functional groups to drive the completion of activities. Managing, coaching and training of QC investigators Supports Quality Control Technical (SME) Review and Approval for the following activities:QC Data and Summary ReportsQC Equipment Audit Trail ReviewsMethod Transfer / Validation Protocols and Final ReportsEquipment URS and IOPQ Protocols Supports QC Audit Inspection Activities including but not limited to the following:Inspection Readiness Assessments for the QC LabsCoordination of Observation ResponsesSME support during regulatory inspections and audits. Support of visual management tiered board systems, including development and monitoring of metrics intended to drive QC business process improvements Supports QC Integration Projects, including equipment lifecycle activities and electronic systems implementation (i.e. LIMS) Identifies and leads the implementation of Operational Excellence activities within the QC Organization.SME for QC Business Processes. Provide support in resolving technical QC issues and ensure alignment is in place for all impacted QC teams. Revise(s) technical documentation (e.g. SOPs, policies, forms, etc.) as required Other duties, as needed / assigned
PROFESSIONAL SKILLS - Solid technical writing skills with scientific discipline Possess an operational excellence mindset Presentation and public speaking skills Must have strong attention to detail as well as ability to work in a cross-functional team environment Excellent organizational skills and the ability to work within a fast-paced environment Multi-disciplinary knowledge of Quality Control and Quality Assurance Strong capability for logical, analytical, and strategic thinking Excellent interpersonal skills and the ability to communicate well both orally and in writing Proficient in Microsoft Office, Excel, and PowerPoint Must be able to manage multiple complex projects Ability to multi-task in a dynamic environment with changing priorities
EXPERIENCE - 12 or more years' experience in a CGMP organization Experience working in a CGMP/ laboratory / Manufacturing environment is required Experience working in a (CMO) contract manufacturing environment is preferred Direct Quality Control and Quality Assurance experience is highly preferred Demonstrated capacity to work independently and in compliance with CGMP
EDUCATION - Master's degree in a scientific field with 8 or more years' experience in a CGMP environment Bachelor's degree in a scientific field with 12 or more years' experience in a CGMP environment
QUALITIES - Resilient, can quickly move forward despite challenges A drive to achieve results while working with limited supervision Positive attitude and strong team, cross team collaboration Honesty, integrity, respect and courtesy with leadership and peers Strong commitment to conducting LSNE business according to the highest legal and ethical standards, and to continually pursue excellence in the manufacturing and delivery of LSNE products and services
PHYSICAL REQUIREMENTS & MENTAL DEMANDS - Routine work requires walking, standing, bending, reaching, climbing stairs, lifting or carrying objects that typically weigh less than 50 lbs. Capacity to work on several tasks simultaneously. Able to organize and prioritize work activities. Flexibility and adaptability with changing priorities Must be able to walk and drive between locations Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves Comfortable with working/handling of hazardous materials
COMMUNICATIONS & CONTACTS: Works closely with departmental Manager in performance of varied activities. Expected to interact with cross staff to coordinate activities
MANAGERIAL & SUPERVISORY RESPONSIBILITIES:
The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.
LSNE Contract Manufacturing https://lyophilization.applicantpro.com
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