- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Microbiology Investigation Writer, Deviations is responsible for the initiation, investigation, and writing of assigned deviations and associated corrective actions, ... preventative actions, and change control documents. The incumbent will be expected to gather data from various sources across the organization to lead and perform Root Cause Analysis to determine the most likely cause of the deviation and identify corrective… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Technician I, QA - Finishing provides direct support for all finishing manufacturing activities. This position supports the Quality Systems within the Quality ... Assurance Unit ensuring compliance with federal regulations for current Good Manufacturing Practice (cGMP) for in process manufacturing pharmaceuticals. Provides Quality Assurance support for all manufacturing activities performed during finishing… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Areas of responsibility include capital projects, manufacturing and facilities equipment installation, troubleshooting, modification and maintenance, utilities, ... preventive maintenance program, contractors, equipment reliability, engineering document and drawing management and critical spare parts. Job ResponsibilitiesResponsible for the direct supervision, performance, training, coaching, counseling and development of… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Following documented procedures using precision standards. Execute calibration procedures and calibration certificates. Perform testing to support the quality ... management system and report, troubleshoot and make recommendations about quality issues relating to calibration. Job ResponsibilitiesPerforms routine calibration of equipment. Calibrations may include (but not limited to): temperature, relative humidity,… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …This role requires excellent organizational, communication, and technical skills to align maintenance operations with production requirements and safety standards.Job ... ResponsibilitiesPlanning and Scheduling: Develop, implement, and maintain preventive and corrective maintenance plans.Create detailed maintenance work orders, including task lists, required materials, labor hours, and safety protocols.Schedule maintenance… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …The Director of Regulatory Affairsis a strategic leader responsible for directing and managing regulatory strategies for multiple pipeline and contract manufactured ... products. The Director plays a leadership role in interactions with the FDA, EMEA, and other regulatory agencies to drive product approvals and maintain correspondence relating to compliance efficiently and with utmost professionalism. The Director of… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …must be enrolled in an accredited school program to be eligible to apply* The L&D Associate helps in the creation, administration, organization and presentation of ... company trainings, programs, meetings, and initiatives. The primary responsibilities of this role include supporting the creation of learning and development initiatives and programs, assisting with, and scheduling learning opportunities. Job Responsibilities:… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Technician I, Operations - Finishing is responsible for assisting with executing finishing activities and completing associated documentation in support of ... inspecting, packaging and/or labeling pharmaceutical products in compliance with all safety policies, cGMPs, and SOPs. This position supports the ongoing development, manufacture, and distribution of pharmaceutical products in compliance with local procedures,… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …This starts with proper risk analysis in manufacturing design, then goes into addressing risk in process validations, and continues with overseeing risk using ... statistical quality control during manufacturing. In addition, addressing known issues with a strong Corrective and Preventive Action system to ensure the root cause is identified and controlled. The Quality Engineer will work collaboratively with the… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …and duties of personnel within the quality department.Perform manufacturing investigations, writing investigation reports, and facilitating corrective and preventive ... actions including:Provide management oversight for quality control, batch records, and material review board.Provide management oversight for all QMS documents and change control. Ensure adherence to procedures.Collaborate with department heads to ensure QMS… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …clean room protocols by complying with garbing and behavior requirements that align to established cGMP practices and techniques Enforce/follow Standard Operating ... Supervisor, ProductionPosition Summary: The Supervisor, Production is responsible for leading daily production personnel activities and completing associated documentation in support of producing pharmaceutical products in compliance with all safety policies,… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …We are seeking a dynamic and experienced Plant Manager to oversee our manufacturing operations. The ideal candidate will have a strong background in Food & Beverage ... or Automotive production, leadership skills, and a commitment to excellence in quality and safety. The Plant Manager will be responsible for ensuring efficient production processes, managing staff, and optimizing operations to meet our company goals.Job… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …The Assistant Operations Manager will work under the direction of the Operations Manager to provide oversight and administrative support while supporting production ... objectives in compliance with all safety procedures, cGMPs, and SOPs. Responsibilities Maintain compliance with cGMP, safety standards and good housekeeping standardsAssist Operations Manager in supervising daily operations Determine staffing requirements,… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Maintenance Technician maintains production and quality by ensuring operation of production machinery and mechanical equipment.Job Responsibilities:Independently ... performs repair/maintenance of GMP utilities and GMP production equipment, while following standard operating proceduresAdhere to preventative maintenance schedules, performing the work within manufacturing or production schedulesUpdate spare parts inventories… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …environmental monitoring excursions, deviations, and sterility failures. The individual is expected to coordinate project execution and to work alongside Sterility ... Position SummaryThe Sterility Assurance Technician is responsible for working to maintain the Contamination Control Strategy for Exela Pharma Sciences, LLC. This individual should be able to work with direction from Sterility Assurance Management to uphold the… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …The reviewer will be responsible for the review of logbooks for daily, monthly, quarterly, and final reviews, as well as reviewing and approving data associated with ... Raw Material, Finished Drug Products, Stability and Microbiology testing. Data Review may include release, raw material, and stability data and laboratory notebooks. Additionally, the reviewer will need to ensure that all activities are performed in compliance… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Analytical Chemist I will provide analytical testing to support ongoing product release, raw material release and stability studies as needed, generate, and review ... technical documents that support raw material and product release and stability, will be responsible for managing activities with good time management to maximize productivity. This position supports the ongoing development, manufacture, and distribution of… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …The incumbent will participate in strategic and technical planning for the QC - Chemistry group, and will be responsible for establishing testing timelines, executing ... the plan and monitoring the results. The incumbent will be responsible for leading and developing QC - Chemistry scientists that support the ongoing development, manufacture, and distribution of pharmaceutical products in compliance with local procedures,… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Analytical Chemist II will perform analytical testing to support ongoing product release, raw material release and stability studies as needed, generate, and review ... technical documents that support raw material and product release and stability under minimal supervision, and will be responsible for managing their activities with good time management to maximize productivity. This position supports the ongoing development,… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …will include:Strong technical skills, be the Subject Matter Expert (SME) from equipment Utilities-HVAC systems. Deep technical expertise in all systems under his/her ... responsibility (GMP Utilities and ancillary systems associated within their facilities) and understanding their applications in pharmaceutical aseptic manufacturing.You will provide technical SME support for mechanical, electrical, and pneumatic improvements… more
