Job Description

Outstanding Biotech company seeks QA Specialist to be responsible for document control functions, issuance of controlled documents, updating of SOP binders, maintenance of training records and sending of training notices, assignment of tracking numbers, support for client and regulatory audits, documentation support for client and regulatory audits, and performance of internal audits. Essential Duties/Responsibilities: -Document Control - -Processing of change controls for new and revised documents using Companys document management system. -Ensure that document reviewers are properly assigned and review timelines are met, edits to documents are performed properly and revisions histories accurately represent the changes made. -Ensure that controlled document binders, if used, are updated with new/revised SOPs and outdated controlled documents are removed from binders. Responsible for ensuring that the SOP table of contents is always current. -Training – -Following approval of the document, the QA specialist is responsible for ensuring that training notices are sent to employees and that than training is completed. -Responsible for ensuring that hard-copy training records are filed according to Company procedures in employee training files and for ensuring that training files remain in a state of audit-readiness. -Maintain the schedule for annual GMP training, coordinating of training dates with staff members, and ensuring that attendance sheets are completed by each person in attendance. Responsible for archiving a copy of the GMP training presentation with training documentation. -Coordination of safety training of staff members for sessions involving environmental health and safety, fire extinguisher training, evaluation training, etc. -Assignment of Tracking Numbers- -Responsible for completion of Quality Assurance logbooks for the assignment of numbers for deviations, CAPAs, batch records, test methods, equipment, product lot numbers, etc. -Support for Client and Regulatory Audits- -Responsible for providing support including locating, inspection, and delivery of requested document to the audit room. -Notifying staff members when their presence is requested by the client or regulatory agency during audits. -Coordination with internal staff members to make necessary corrections to document that are identified during the audit. -Perform the functions of note taker/scribe during audits if requested by QA management. -Support for Calibration and Preventive Maintenance of Equipment- -Responsible for review of calibration certificates for compliance with SOP requirements and equipment specifications. -Notification of QA management and the department equipment owner of all “as-found” calibration failures. -Assignment of investigation numbers and management of the tracking system for completion. -Internal Audits – -At the request of QA management, perform internal audits of Company quality systems and records for GMP laboratories, manufacturing, facilities and shipping/receiving Experience: •3-5 years of Qualty Control or analytical/bioanalytical chemistry experience in a GMP laboratory in the pharmaceutical industry. Education: •College Degree required in chemistry, biochemistry, biology, or related science

Company Description

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