QA Specialist

  • Anywhere

Company :
RCM Technologies

Location :
Durham, North Carolina

Expiry Date :
Mon, 14 Jun 2021 23:59:59 GMT

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Description :
Reference # : 21-00377 Title : QA Specialist Location : Durham, NC Position Type : Full Time/Contract Experience Level : 6 Years Start Date / End Date : 07/01/2021 / 12/31/2021 Description QA specialist with a BS in Science/Engineering and at least six years of experince within the Life Sciences industry performing : Quality Assurance Specialists Tasks * Evaluate documentation compliance for all equipment and support areas. * Review and approve CSV Installation and Operational Qualification Protocol (IOQ) for computerized systems, and/or automated manufacturing/laboratory equipment, processes, and systems with respective reports. * Review and approve the Process/Laboratory Performance qualification protocols, Traceability Matrix document, and Validation Reports. * Review and approve all equipment, utilities, facilities, process, and product and computer systems validation protocols and reports, change control documentation, redressing / reprocessing / rework operations, investigation reports related to manufacturing process and analytical and microbiology laboratory, and Annual Product Quality Review (APQR’s) elements. * Review and approve equipment / facilities / system validation documents. * Review and approve procedures related to process, products, utilities, and laboratories, and ensures compliance of all procedures (SOPs). * Review and approve actively the investigation process occurred in manufacturing, warehouse, calibration, laboratories, facilities, and utility areas related to process, products, and others providing coaching from the Quality perspective. Provides scientific input into investigation. * Support risk analysis process. * Manage audit observation, investigations, change control and CAPAs records in Track Wise on a timely manner. * Participates in Manufacturing Alignment Teams (MAT) and Project Alignment Teams (PAT), or as named by Patheon, and the various board meetings, as required. * Review and approve the Commissioning Packages for the utilities and infrastructure systems, as applicable. * Develop sampling plans based on acceptance quality level criteria, as required. * Evaluate and approve the instrumentation and equipment calibration records and critical engineering drawings. * Ensure there are effective systems for maintenance and calibration of equipment. * Perform shop floor walk through audits and challenge adherence with area procedures, coaching, and Quality Support. * Verify consistency with other site procedures and/or specifications. * Review and approve Corrective and Preventive Actions (CAPAs). From a Data Integrity perspective: * Review and approve required CAPAs or recommended actions required to support a project from a computer and automated systems SME perspective. * Review and approve computer and automated systems’ current designs, functionalities, limitations, and controls to be able to recommend improvements or necessary actions to mitigate any related risk. * Review and approve IT and/or Automation procedures to address Data Integrity identified risks or improvements needed following Patheon procedures. These procedures may be for Administration, Backup/Restore, Archiving, etc. * Review and approve IT and/or Automation preventive/proactive maintenance activities within CMMS (Maximo), if applicable, within the site to address associated risks or improvements needed, following Patheon procedures. * Review and approve necessary trainings and communication to the technical group to implement effective procedures or maintenance activities. * Review and approve automated and computer systems controls, evaluated risks, and developed risk assessments, as required. From a Validation perspective: * Review and approve protocols for all processes / equipment / systems to be qualified/validated based on corporate guidelines and procedures. * Review and approve equipment / facilities / system validation documents. * Review and approve validation activities with related departments, as applicable. * Review and approve performance of qualification/validation studies as per established protocols. * Review and approve reports on all the studies/projects assigned in accordance with protocol. * Review and approve process/equipment performance during the studies for acceptability. * Review and approve technical support to user on qualified/validated systems/processes. * Review and approve documentation records in accordance with cGMPs, and other regulations. * Review and approve alternatives for enhancement to qualification and validation processes. * Review and approve validation programs in conformance with department standards. * Review and approve utilization of statistical tools and other techniques to assess performance of studies. * Assist management during FDA and HA (Health Agencies) inspections. * Review and approve annual revision of the validation program in the validation Master Plans. * Review and approve updates on operational procedures of validated equipment/systems. * Review and approve training of personnel in updated operational procedures, as requested. * Provide collaboration with internal/external clients, as requested. * Provide support and necessary actions to the site Quality Management System (QMS) elements. RCM Technologies is a leading provider of IT Business Solutions and Engineering Services to over 1,000 clients in the commercial and government sectors. RCM partners with clients to define implement and manage a broad range of technologies across multiple platforms, systems, and networks. Our broad geographic presence ensures that a proven and reliable tactical and strategic capability is available and deployable virtually everywhere in North America. RCM Technologies, (USA) Inc. is an Equal Opportunity Employer M/F/D/V. RCMT encourages applicants of all ages.