Mark Webking Email & Phone Number

Littleton, Co, Us

Colorado, United States

Remote

Provide support for the implementation of a global LIMS system across multiple sites Ensure compliance with current Good Manufacturing Practices (cGMP) and Quality Management System standards Collaborate closely with several different Quality Control labs in the synchronization of test methods, SOPs, and specifications used in LIMS Apply previous work experiences to identify and extract relevant information from source documents. Transfer data from existing documentation (Excel, Word, and PDF files) to standardized Excel templates and apply the defined harmonization rules and data standards where appropriate Organize existing data in spreadsheets as required to properly display and work effectively through data entry activities

Portage, Michigan, United States

Work effectively in a fast-paced, customer-oriented, team laboratory environment to analyze in-process materials, solvents, raw materials, APIs, and/or finished product samples in direct support of the company's production units Independently perform testing and document results for qualitative or quantitative assays on samples using techniques that vary from use of standard laboratory equipment to highly modern and automated instrumentation Technologies employed include GC, titrations, Karl Fisher, and general analytical procedures Develop, improve, or customize products, equipment, formulas, processes, or analytical methods Troubleshoot test methods and analytical procedures Participate in laboratory investigations

Jackson, Michigan Area

Analyze routine raw material, in-process, and finished good samples using various laboratory techniques including Gas Chromatography (GC), Inter Coupled Plasma (ICP), and other methodology such as particle size analyzer, density meter, viscometer, etc. Provide timely and accurate documentation of all analytical data according to Standard Operation Procedures (SOP) and perform appropriate analyses Interpret test results, compare them to established specifications and control limits, and make recommendations on appropriateness of data for release Escalate out-of-spec materials to QC Lab Supervisor for data review Participate in out-of-spec and failure investigations and recommend corrective actions Aid in management of inventory of consumables such as GC columns, spare parts, reference standards, and control samples Complete routine troubleshooting, calibration, validation, and maintenance of laboratory equipment Identify and implement process improvement in laboratory functions and analytical methods Review data from contract laboratories to ensure accuracy and regulatory compliance Write or revise standard quality control operating procedures Develop and qualify new testing methods Serve as a technical liaison between quality control and other departments, vendors, and contractors Train other analysts to perform laboratory procedures and assays

Greater Detroit Area

Provide support in the root cause analysis and closure of OOS investigations, OOT investigations, and product quality complaints Ensure compliance with current Good Manufacturing Practices (cGMP) and Quality Management System standards Collaborate with manufacturing, plant services, engineering to ensure timely documentation, root cause analysis, and QA closure of Stage II OOS investigations and OOT investigations Author/revise Standard Operating Procedures (SOP) and batch records, as required Provide technical review of data or reports to be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation Review product promotional materials, labeling, batch records, specification sheets, and test methods for compliance with applicable regulations and policies Interpret regulatory rules or rule changes and ensure their communication through corporate policies and procedures Escort government inspectors during inspections and provide post-inspection follow-up information as requested Complete routine troubleshooting, calibration, validation, and maintenance of laboratory equipment Perform validations or transfers of analytical methods in accordance with applicable policies and guidelines Receive and inspect raw materials Review data from contract laboratories to ensure accuracy and regulatory compliance Evaluate new technologies and methods and make recommendations regarding their use Train other analysts to perform laboratory procedures and assays