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Job #03098

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 Manager Cleveland, Ohio Salary Highly competitive package, commensurate with experience Responsibilities 1) Revise and approve specifications and spec checks 2) Approve and reject test lots for the customer and company 3) Handle calibration and standardization, internal audits, close out, complaints and input test data in LIMS 4) Determine rework decisions as well as compile and approve data for OOS 5) Perform validation studies as well as revise SOPs, WI, PREPS, forms and specs and performance evaluations 6) Develop and document in-house specifications for products and raw materials 7) Oversee QC release of in-process, intermediate and final product to internal and external customer orders or to stock (as directed by procedure) 8) Ensure that all customer requirements are met prior to release including initial approval and the performance of spec checks 9) Prepare and issue internal labels to manufacturing/production for further manufacturing, approval and rejection 10) Follow re-testing and rejection procedure for raw material, intermediates and finished products 11) Supervise Quality Control Manager, Quality Systems Document and Data Control Coordinator, Quality Engineer and Molecular Biology Supervisor (HR-001) 12) Comply with the quality system effectiveness and ISO 9001:2000 guidelines 13) Act as management representative for quality system policy 14) Bring processes under control and improve them 15) Increase teamwork, break down barriers between departments and increase efficiencies in all departments 16) Evaluate and maintain all SOPs, specifications and preps within the company 17) Maintain document controls and ensure availability of required documents at point of use 18) Handle archiving/retrieval/deletions of obsolete documents and approve change control procedures 19) Train, support and provide assistance and direction to all departments in writing and implementing SOPs 20) Facilitate external customer audits of all areas throughout the company for compliance 21) Conduct internal, external and supplier audits 22) Oversee customer quality systems needs 23) Maintain and compile reviews of all nonconforming materials, customer complaints, preventative and corrective actions, internal incidents and external corrective actions 24) Report any issues related to quality systems and chair the Material Review Board 25) Provide quality system parameters to board members 26) Supervise the maintenance of vendor/supplier list and database 27) Evaluate suppliers as per SOP (probationary, approved and deselected) 28) Manage quality tasks for MSS manufacturing system 29) Ensure calibration and certification of appropriate measurement equipment 30) Research and develop standardization and calibration requirements and procedures for control equipment (QC, Production, Molecular Biology and S/R) 31) Manage process change documentation as well as qualification of equipment 32) Oversee notification of specification changes, analytical test method changes, raw material changes, equipment change and process changes to customers 33) Train and update training logs of all employees relating to ISO 9001:2000, cGMP and quality system guidelines 34) Manage inspection, screening determination and internal labeling of bulk material 35) Oversee review of batch records for final compilation 36) Supervise QC lot record, manufacturing record, blend sheets, packaging sheets and labels 37) Ensure environmental monitoring is performed for defined production, sampling, product storage and raw material storage areas 38) Determine SOPs for label protocols and control for internal and external use 39) Manage QC evaluation of customers' specifications 40) Determine sampling protocols throughout the company 41) Advise Shipping, Production and/or front office of additional testing or modification necessary for meeting these specifications (specifications sign-off forms) 42) Verify chemical information (storage conditions, specifications, molecular weight, molecular formula, structure, CI Index, CAS, schedule B) as needed for raw materials, intermediates and products 43) Draft changes for review by Material Review Board 44) Attend customer complaints and provide technical assistance to customers 45) Correspond with customers in a professional manner to resolve customers’ complaints and respond to technical questions 46) Advise Material Review Board of changes to products and route appropriate departments of changes 47) Assign Schedule B and HTS numbers 48) Oversee SPC program and MSS set of related to process yields 49) Coordinate maintenance of customer database 50) Ensure customers’ specifications are met 51) Initiate action to prevent the occurrence of nonconformities to product, process and quality system 52) Implement corrective actions and solutions to non-conformance 53) Identify and record non-conformances using standard SOPs and communicate this nonconformance per SOP 54) Control further processing and delivery of nonconforming product 55) Follow up on preventive and corrective actions as well as solutions to problems within the quality system 56) Interface with the HR for employee issues 57) Visit customers as well as attend supplier and scientific shows 58) Interface with Marketing Department regarding catalog, promotional and quality marketing materials 59) Manage the timely processing and completion of performance evaluations for assigned departmental staff as per designated due dates communicated by HR 60) Organize and maintain a clean and orderly work area in accordance with the administrative General Housekeeping Policy 61) Follow general personal protective equipment (PPE) requirements as established by company policy 62) Perform all functions in a safe and timely manner as per OSHA standards as well as general rules and regulations governing the work place 63) Keep specification files current in the controlled areas 64) Chart guidelines for quality systemic changes and advises members of quality requirements in individual departments 65) Seek guidance from Supervisor as needed to ensure all duties are performed 66) Attend and be punctual for appropriate meetings and training in-services 67) Perform all other duties as assigned Requirements 1) BS in a related scientific field (Ph. D. or MS preferred) 2) Minimum 5 –10 years of experience in a quality assurance/quality systems related field 3) Minimum 3 years of supervisory experience 4) Minimum 1 – 2 years of laboratory experience 5) Strong GMP/GLP experience 6) Experience in ISO 9001:2000 guidelines 7) Expertise in non-routine analytical methods, process studies and changes 8) Knowledge of qualifying new equipment, changes to existing equipment and validation guidelines (company-wide)