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120v7 roles and responsibilities

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  • 1. d te in Pr n he W d lle t ro onncUThis document is uncontrolled when printed. For the current, official copy of this SOP, refer to Exovas Intranet.
  • 2. SOP No. 120 Rev 71.0 SUMMARYBelow are general descriptions of the duties, responsibilities, authorizations, and trainingrequired for various employment positions. These positions correlate with Exova titles as shownin Table 1 below. Job responsibilities should be considered cumulative, e.g. a DepartmentManager has the responsibilities of subordinate positions as well as those particular to theirposition. As needed, personnel may also be assigned specific duties which have not been listedhere but which are consistent with their education, experience and/or training. dExova procedures detail the employee responsible for performing specific tasks. In accordance tewith normal management practice, it is acceptable for the designated person to delegate theactual performance of the task to another individual with the appropriate combination of ineducation, training, or experience to perform that function. However, the responsibility forensuring that the task is carried out cannot be delegated. Pr2.0 RESPONSIBLE PERSONS nThe General Manager is responsible for this SOP. Annual employee training on this document is herequired. W3.0 JOB DESCRIPTIONS dWhere educational requirements are stated, twice the work experience in the associated fieldmay suffice. For example, 8 years of experience in an analytical chemistry lab may satisfy the llerequirement for a 4 year B.S. degree. ro 3.1 Assistant t 3.1.1 Administrative Assistant on High School graduation required but no specific prior experience required. nc Performs non-technical tasks, including support of business functions such as invoicing and generation of purchase orders under the direct supervision of theU Office Manager. 3.1.2 Client Services Assistant High School graduation required but no specific prior experience required. Prepares and distributes laboratory reports for review and provides administrative support to the department under the direct supervision of the Client Services Director. Page 2 of 10 This document is uncontrolled when printed. For the current, official copy of this SOP, refer to Exovas Intranet.
  • 3. SOP No. 120 Rev 7 3.1.3 Sample Assistant High School graduation required but no specific prior experience required. Supports sample receipt and disposal functions. Reports to Sample Coordinator. 3.1.4 QA Assistant High School graduation required but no specific prior experience required. Assists in documentation control and supports quality systems, including reagent d and materials receipt under the direct supervision of the HSEQ Officer or QA te Coordinator. in 3.2 Technician Pr 3.2.1 Sample Preparation or Extraction Technician High School graduation required but no specific prior experience required. n Performs routine equipment calibration verifications and prepares samples, reagents, and standards for analysis with associated documentation under the he direct supervision of the Supervisor or Department Manager. Is authorized to perform peer review of documentation. W 3.2.2 Sample Receptionist d High School graduation required but no specific prior experience required. Receives and disposes of samples and performs associated documentation and lle data entry under the direct supervision of the Sample Coordinator. ro 3.3 Technologist t 3.3.1 IT/IS Assistant on B.S. in a scientific discipline and two years computer system maintenance nc experience. Assists with maintaining hardware and software used by the company and performing software and spreadsheet validations. May assist with networkU backups and software development. Trains employees on computer operations and provides technical support. Reports to the IT/IS Department Manager. 3.3.2 Facilities Technologist High School graduation required. Five years experience in routine facilities support including HVAC, minor electrical/cable, pest control, plumbing (water and gas), project management, and any other facility requirements. Performs associated documentation of activities. Page 3 of 10 This document is uncontrolled when printed. For the current, official copy of this SOP, refer to Exovas Intranet.
  • 4. SOP No. 120 Rev 7 3.3.3 Client Services Representative B.S. Degree with two years experience in the analytical chemistry industry. Organizes and directs work on projects through other managers and Group Leaders, handles client inquiries, prepares proposals and bids, and communicates results to clients as authorized by the Department Manager or their designee. Reports to Client Services Director or General Manager. 3.3.4 QA Chemist, Data Reviewer d te B.S. in a scientific discipline, preferably chemistry, with two years experience as a chemist. Performs data package QA review, laboratory investigations including in root cause analysis and corrective/preventive actions, reviews and approves retest and reanalysis forms, and other quality system documentation. Participates in Pr process, system, and data internal audits and assists with third-party audits. Reports to the HSEQ Officer. n 3.3.5 QA Senior Chemist, Data Reviewer he B.S. in a scientific discipline, preferably chemistry, with five years experience as a chemist and two years experience in quality assurance. Performs data package W QA review, performs and closes laboratory investigations, reviews and approves retest and reanalysis forms and other documentation. Leads process, system, and data internal audits and assists with third-party audits. Trains employees in d quality systems. Communicates with clients and auditors regarding data and quality systems. Reports to the HSEQ Officer. lle 3.4 Analyst ro 3.4.1 Chemist t on B.S. in a scientific discipline, preferably chemistry, with 0-2 years experience. Performs routine analyses and associated documentation, may perform routine nc equipment maintenance, prepares data packages for review, notifies supervisor of Out-of-Specification, laboratory incident, and QC Action events. Is authorized toU perform peer review of documentation. Reports to, and is closely supervised by, an Analytical Chemist or Department Manager. Page 4 of 10 This document is uncontrolled when printed. For the current, official copy of this SOP, refer to Exovas Intranet.
  • 5. SOP No. 120 Rev 7 3.4.2 Senior Chemist B.S. in the sciences and five years relevant experience. Trained to perform and supervise a variety of routine and some non-routine tasks, evaluates and develops new methods, authors and approves SOP’s, performs non-routine instrument repair, prepares and reviews data packages, is authorized to give opinions and interpretations in final reports when clearly identified as such, contacts clients with results or for resolution of problems, approves investigations of Out-of-Specification results, may be assigned to sign final reports, helps train other chemists, requisitions routine and non-routine supplies and equipment. d Reports to Department Manager, General Manager, or Technical Director. te 3.4.3 Senior Staff Chemist in B.S. and 10 years experience. Performs routine and non-routine tasks and Pr analyses, develops new methods, performs complex instrument repairs, prepares and reviews data packages and narratives, is authorized to give opinions and interpretations in final reports when clearly identified as such, works with clients n on technical issues, trains other chemists, requisitions non-routine supplies and equipment. Reports to Department Manager, General Manager, or Technical he Director. W 3.4.4 Principle Investigator Sr. Chemist or above who is assigned by the Technical Director or HSEQ Officer d to projects which must comply with Good Laboratory Practices (GLP). Responsible for overall study from a technical standpoint, including conducting lle the study according to protocol, interpreting the results, documenting and verifying results, obtaining approval of protocol changes, selecting corrective ro action, compliance of study with GLP, and archival of all raw data, documentation, protocol, specimens, and reports at the close of the study. Reports t to Study Director for the scope of the project; the Study Director is usually on assigned by the client, external to this laboratory. nc 3.4.5 Senior ScientistU Ph.D. and 20 years experience. Prepares method validation protocols, performs routine and non-routine analyses, develops new methods, performs complex instrument repairs, prepares and reviews data packages and narratives, is authorized to give opinions and interpretations in final reports when clearly identified as such, works with clients on technical issues, trains others, requisitions non-routine supplies and equipment. Reports to General Manager or Technical Director. Page 5 of 10 This document is uncontrolled when printed. For the current, official copy of this SOP, refer to Exovas Intranet.
  • 6. SOP No. 120 Rev 7 3.5 Coordinator 3.5.1 Sample Coordinator High School graduation required. Reviews incoming Analytical Request Forms and other sample receipt documentation. Prepares and issues Job Sheets to Department Managers. Supervises sample receipt and disposal and is authorized to contact clients regarding execution of contracted services. d 3.5.2 QA Coordinator te Sr. Chemist or above who maintains QA databases, including the equipment in qualification schedule; prepares and reviews QA trend reports including the annual management review; may work with clients and Managers to develop QA Pr project plans; assists the Technical Director and HSEQ Officer in maintaining SOP’s and the QA Manual. Hosts third-party audits. Reports to HSEQ Officer. n 3.5.3 Health, Safety and Environmental (HSE) Coordinator he Sr. Chemist or above who assists chemists in safely handling chemicals and other hazards, coordinates hazardous waste disposal, conducts safety meetings and W safety training, and assists in maintaining the Safety Manual. Requires current HAZWOPR supervisor level certification. Heads the Joint Health and Safety Committee. Reports to the HSEQ Officer. d 3.5.4 IT/IS Coordinator lle B.S. in a scientific discipline and two years laboratory computer system ro experience. Responsible for maintaining hardware and software used by analytical instrumentation to include the network, spreadsheet and word t processing software, printers and workstations. Responsible for maintaining on network backups and SOP’s associated with the computers and network. May work on software development and validation projects. Trains employees on nc computer operations and provides technical support. Reports to the IT/IS Department Manager.U 3.6 Department Manager 3.6.1 Client Services Director B.S in a business or scientific discipline with 10 years lab management experience. Responsible for sample receiving, sample control, report generation and distribution, client communication, and marketing literature. Reports to General Manager. Page 6 of 10 This document is uncontrolled when printed. For the current, official copy of this SOP, refer to Exovas Intranet.
  • 7. SOP No. 120 Rev 7 3.6.2 Group Leader Sr. Chemist or above who is additionally responsible for all SOP’s for their group; ensures that the analysts have read, understood, and signed-off on SOP’s, and that analysts have the training, information, qualification, and resources to perform their assignments; assigns tasks and schedules to those in group; enforces safety and QA policies in group; maintains equipment and calls contractor for repairs when needed; maintains outstanding job lists and attends staff meetings to assess turnaround times; reviews and signs data packages; reviews instrument and maintenance logs; approves the use of Out-of-Control Limits data; performs d out-of-specification and other laboratory investigations; approves overtime and te time-off requests; works with managers and directors to meet project schedules and goals; administrates personnel policies within group, and conducts in performance and salary reviews for group; approves requisitions of supplies up to $1000. Reports to General Manager or Technical Director. Pr 3.6.3 Business Development Executive n Two years sales experience in the services industry who develops and markets services through presentations and visits to clients. Reports to General Manager. he 3.6.4 IT/IS Department Manager W B.S. in a scientific discipline and two years computer system maintenance experience. Responsible for maintaining hardware and software used by the d company to include the network, Visual FoxPro Job Tracking, spreadsheet and word processing software, printers and workstations. Responsible for maintaining lle network backups and SOP’s associated with the computers and network. May work on software development and validation projects. Trains employees on ro computer operations and provides technical support. Reports to the corporate IT/IS Director. t on 3.6.5 Office Manager nc B.S. degree and 10 years experience in the laboratory services industry. Responsible for administration of the accounts receivable and payable,U purchasing, capital expenditures, and human resources. Page 7 of 10 This document is uncontrolled when printed. For the current, official copy of this SOP, refer to Exovas Intranet.
  • 8. SOP No. 120 Rev 7 3.7 Senior Management 3.7.1 HSEQ Officer Sr. Chemist or above with three or more years auditing experience in the pharmaceutical, biologics, or medical device industry; training in ISO/IEC 17025; training in statistics; and at least one year of non-academic analytical chemistry experience. Ensures that the management system related to quality is implemented and followed at all times; maintains the QA Manual; works with d other managers to train personnel; manages complaint and laboratory te investigations, training and employee qualification, vendor qualification, equipment qualifications, and change controls; supports sales and marketing; in assists the Technical Director in maintaining SOP’s; and heads the Quality Assurance Unit for GLP and GMP projects. Approves Quality Agreements with Pr clients and responses to client and regulatory audits. Coomunicates results of internal and third-party audits to Management. In conjunction with the General Manager, establish quality management objectives for the continual improvement n of the management system which are reviewed during management review. Manages the safety training and monitoring program and maintains the Safety he Manual. Reports to General Manager and the Corporate HSEQ Director. W 3.7.2 Technical Director Sr. Staff Chemist who has a working knowledge of all technical aspects of the d laboratory. Responsible for the quality of data, including technical compliance with ISO/IEC 17025, GMP/GLP, and other applicable regulatory standards; lle SOP’s for laboratory operations and technical training of personnel; prepares method validation protocols; conducts performance and salary reviews of ro Managers with the General Manager; approves use of Out-of-Control Limits data; closes complaint and laboratory investigations; keeps the lab current on technical t issues; evaluates and develops new methods; conducts training classes; prepares on technical presentations and papers; first signature on reports (unless not available); knowledgeable in all methods required by regulations. Three years or nc more non-academic analytical laboratory experience in metals analysis is required. Reports to General Manager.U Page 8 of 10 This document is uncontrolled when printed. For the current, official copy of this SOP, refer to Exovas Intranet.
  • 9. SOP No. 120 Rev 7 3.8 Executive Management - General Manager Sr. Chemist or above who is responsible for scheduling and administration of the entire laboratory, provides final approval of time off and overtime, conducts performance and salary reviews of Managers, works with corporate on developing and implementing personnel policies, supports marketing and sales personnel, approves proposals, contracts, and bids, conducts training, approves vendors, recommends equipment purchases, approves requisitions up to $10,000, maintains operational SOP’s. In conjunction with the HSEQ Officer, is responsible for implementation, maintenance and d improvement of the management system, including compliance with ISO/IEC 17025, te GMP/GLP, OSHA, and other applicable regulatory standards. Ensure that laboratory management and personnel are free from any undue internal and external commercial, in financial or other pressures and influences that may adversely affect the quality of their work. Closes complaint investigations, maintains certifications and accreditations, and Pr approves the QA and Safety Manuals. Approves responses to client and regulatory audits; reviews internal audits, management reviews, and trend reports. Is responsible for profitability of the business, marketing, and short and long term planning; prepares large n bids and proposals. Reports to the Executive Vice-President of the Health Services and Analytical Division of Exova. he W d lle t ro on ncU Page 9 of 10 This document is uncontrolled when printed. For the current, official copy of this SOP, refer to Exovas Intranet.
  • 10. SOP No. 120 Rev 7 Table 1. Correlation of Exova Titles and Job Function Exova Position Exova Functional Title Assistant Administrative Assistant QA Assistant Sample Assistant Client Services Assistant Technician Sample Prep Technician d Extraction Technician te Sample Receptionist in Technologist Facilities Technologist IT/IS Assistant Pr Client Services Representative QA Senior Chemist - Data Reviewer QA Chemist - Data Reviewer n Analyst Chemist he Senior Chemist Senior Staff Chemist W Principle Investigator Senior Scientist d Coordinator QA Coordinator IT/IS Coordinator lle HSE Coordinator Sample Coordinator ro Department Manager GC/GCMS Group Leader t Inorganics Group Leader on IC/LC Group Leader Wet Chemistry Group Leader nc Spectroscopy Group Leader IT/IS Department ManagerU Client Services Director Business Development Executive Office Manager Senior Management HSEQ Officer Technical Director Executive Management General Manager Page 10 of 10 This document is uncontrolled when printed. For the current, official copy of this SOP, refer to Exovas Intranet.