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Job #03579

About our client Our client, based in Ohio, is a leading manufacturer of biochemical and biological products for use in the biotech and pharmaceutical industry. The company has an experienced management team, a broad range of products and an empowering corporate culture that is focused on the long-term professional development of its employees. Position Location Quality Systems Director Ohio Salary Highly competitive package, commensurate with experience Responsibilities 1) Use ISO 9001:2000 and cGMP guidelines for evaluating the quality system of the company 2) Prepare and implement procedures that are consistent with ISO 9001:2000 and cGMP guidelines 3) Establish guidelines and provide assistance to all departments to meet the quality requirement for an effective and efficient quality system that complies with ISO 9001:2000 4) Prepare and host customers during customer audits 5) Represent ISO 9001:2000 and report to executive management 6) Promote awareness of customer requirements throughout the organization 7) Ensure that processes needed for quality management system are established, implemented and maintained 8) Revise and approve specifications 9) Conduct spec check, approve and reject test lots for customer and RO, calibration and standardization, internal audits 10) Close out CARS and complaints, input test data in LIMS 11) Determine rework decisions, compile and approve data for OOS, validation studies, revise SOPs, WI, PREPS, forms and specs and conduct performance evaluations 12) Develop and document in-house specifications for products and raw materials and keep specification files current in the controlled areas 13) Oversee quality control release of in-process, intermediate and final product to internal and external customer orders or to stock as directed by procedure 14) Ensure that all customer requirements are met prior to release including initial approval and the performance of spec checks 15) Prepare and issue internal labels to Manufacturing/Production for further manufacturing, approval and rejection 16) Follow re-testing and rejection procedure for raw material, intermediates and finished products 17) Supervise Quality Control Manager, Quality Systems Document and Data Control Coordinator, Quality Engineer and Molecular Biology Supervisor 18) Comply with effective quality system and ISO 9001:2000 guidelines 19) Act as management representative for Quality System Policy 20) Bring processes under control, improve processes, increase teamwork, break down barriers between departments and increase efficiencies in all departments (Quality Manual) 21) Evaluate and maintain all SOPs, specifications and preps within the company 22) Maintain document controls and ensure availability of required documents at point of use, archive/retrieve/delete obsolete documents and approve change control procedures 23) Train support and provide assistance and direction to all departments in writing and implementing SOPs 24) Facilitate external customer audits of all areas throughout the company and conduct internal, external and supplier audits 25) Oversee customer quality systems needs, supplier surveys/contracts, specification sign-off, technical assistance and compliance with quality system needs of customers 26) Maintain and compile review of all nonconforming materials, customer complaints, preventative/corrective actions, internal incidents, external corrective actions used for management review requirements of ISO 9001:2000 and quality system 27) Chair Material Review Board and report any issues related to quality systems 28) Provide quality system parameters to board members, chart guidelines for quality systemic changes and advise members of quality requirements in all departments 29) Supervise the maintenance of vendor/supplier list and database 30) Evaluate supplier as per SOP (probationary), approved and deselected 31) Manage quality responsibility for MSS manufacturing system 32) Ensure calibration and certification of appropriate measurement equipment 33) Conduct R&D on standardization, calibration requirements and procedures for control equipment (Quality Control, Production, Molecular Biology and S/R) 34) Manage process change documentation and qualification of equipment 35) Notify specification changes, analytical test method changes, raw material changes, equipment change and process changes to customers as required 36) Train and update training logs of all employees relating to ISO 9001:2000, cGMP and quality system guidelines 37) Conduct inspection, determine screening and label (internally) bulk material 38) Oversee reviewing of batch records for final compilation (QC lot record, manufacturing record, blend sheets, packaging sheets and labels) 39) Ensure environmental monitoring is performed of defined production, sampling, product storage and raw material storage areas 40) Determine SOPs for label protocols and control for internal and external use and sampling protocols throughout the company 41) Manage QC evaluation of customers' specification and advise shipping, production and/or front office of additional testing or modification necessary for meeting the specifications 42) Verify chemical information as needed for raw materials, intermediates and products 43) Outline changes for review by Material Review Board 44) Take customer complaints, provide technical assistance, correspond to resolve the complaints and respond to technical questions 45) Advise Material Review Board of changes to products and routes appropriate departments of changes and assign Schedule B and HTS numbers 46) Oversee SPC program and MSS set of related to process yields 47) Coordinate maintenance of customer database (sign off specifications and interface with customers to ensure their specifications will be met) 48) Initiate action to prevent the occurrence of nonconformities to product, process and quality system (preventive/corrective action and internal audit resolution) 49) Implement corrective actions and solutions to non-conformances 50) Identify and record non-conformances using standard SOPs and communicate this nonconformance and control further processing and delivery of nonconforming product 51) Follow up on preventive/corrective actions and solve problems within the quality system and interface with the HR for employee issues 52) Interface with Marketing Department for catalogs, promotional and quality marketing materials 53) Visit customers, attend supplier and scientific shows 54) Conduct timely processing and completion of performance evaluations for departmental staff according to designated due dates communicated by HR 55) Organize and maintain a clean and orderly work area in accordance with the administrative General Housekeeping Policy 56) Follow general PPE requirements and perform all functions in a timely manner as per OSHA and general rules and seek guidance from supervisor when required 57) Attend meetings and training in-services punctually 58) Perform other duties as assigned Requirements 1) BS in a related scientific field (Ph. D. or MS preferred) 2) 5 – 10 years of experience in a quality assurance/quality systems related field 3) 1 – 2 years of laboratory and 3 years of supervisory experience 4) Strong experience in GMP/GLP, ISO 9001:2000 and non-routine analytical method 5) Experience in process studies and changes, qualifying new equipment, changes to existing equipment and validation guidelines