Scott Wallach Email & Phone Number

Lake Forest, Il, Us

The primary responsibility of the data reviewer is to ensure all data and documentation, including source data and summary reports from the laboratory, are of the highest quality, ensuring data accuracy and integrity. The data reviewer reviews all microbiological data (source data and summary reports) for accuracy, conformance to procedures and specifications, and proper documentation in accordance with SOPs and cGMPs. The assigned individual also reviews raw data, for use of appropriate microbiological instrumentation use, accuracy of calculations and conformance to all referenced microbiological procedures and reviews the interpretation of the data for alignment with method validation reports and scientific legitimacyReviews all source data and associated documentation for accuracy and cGMP conformance and data for conformance to applicable specifications• Facilitates data or documentation corrections with analysts to ensure all records are complete and appropriate references are made.• Ensures investigations are assigned, completed and referenced for data or documentation, as appropriate, prior to release of Microbiological data• Review of laboratory notebooks and other source data (e.g. printouts, logbooks, executed forms, etc.) for completeness, and archival, as appropriate.• Interacts closely with Quality Management and all team members to identify and aid in the implementation of data security, integrity or efficiency improvements• Interacts routinely with departments such as Production, QA, RA, R&D, Validation• Assist in performing Quality Assurance audits on laboratory areas to ensure cGMP compliance• Assist in the investigation and review of deviation reports and OOS reports to assure complete and compliant source data.• Reviews all source data for conformance to applicable specifications• Ensures investigations are assigned, completed and referenced for data or documentation, as appropriate, prior to release of Microbiological data

Indianapolis, Indiana, Us

Responsible for the handling and preparation of samples for testing. Maintaining and documenting accurate records.Assisting with the verification and reporting of test results. The QC Inspector is responsible for the inspection and releaselabeling of raw material and GMP supplies according to theirpriority.• Perform and document physical inspections in accordance withprocedures and specifications• Status label release, reject, quarantine materials based onmaterial disposition• Maintain current tracker for all materials received, inspected,release, etc. • Responsible for entering material, sampled, releasing in LIMS to obtain reception ID# and entering vendor lot number and expiration date, releasing, sampled in SAP.

Internal expert on Archive process and assist department personnel in the proper organization of quality record to ensure efficient archiving process and maintained accurate tracking and inventory of records in retention with accurate tracking and inventory of records in retention.Followed SOP’s and utilize Record Retention database system to enter quality records into long-term storage.• Interface with Archive Service to resolve process issue. • Catalog quality records per record retention schedule• Organize, file and box document for record retention archive, following approved standard operating procedures (SOP).

Switzerland 🇨🇭 , Ch

Switzerland 🇨🇭 , Ch

• Directed work groups which conducted aseptic filling operations and Diagnostic Packaging operations ensuring accuracy, quality and timeliness of multiple daily Filling, Packaging and Label Printing processes.• Ensured all necessary production documentation and associated SAP transactions were performed in a manner that met requirements pertaining to lot numbers, expiration dates, intermediaries and reconciliations.• Issued work orders and contracted with outside vendors for parts and repairs and participated in the execution and co-authorship of Validation protocols.• Ensured inspection of products for defects and conformance to quality standards and applicable SOPs and that all require in-process product checks were performed as required.• Supervised the review of completed production paperwork for completeness and accuracy of the transactions performed.

Switzerland 🇨🇭 , Ch

• Performed warehousing activities including: issuing, returns, internal distribution of goods, receiving and shipping. • Ensured all Filling/Packaging/Labeling tasks were performed in accordance with SOPs, OSRs ad all safety and regulatory requirements. • Participated in the dispensing of hazardous material and ensured operation was performed in a safe and efficient manner • Served as a technical resource and mentor to members of work groups to resolve logistics and planning issues and improve performance

Switzerland 🇨🇭 , Ch

• Performed aseptic gowning and all filling tasks in the aseptic environment to ensure products were not contaminated.• Participated in the operation of filling, labeling & packaging equipment of varying complexity in accordance with Production Manufacturing Records, applicable SOPs, and ISO and cGMPs requirements producing finished intermediaries and final kits.• Cleaned work area and decontaminated work surfaces and performed duties in accordance with SOPs. QSRs and all safety regulatory requirements • Conducted in-process quality checks for specific quality attributes (Fill Check Torque check, Vision System Check, and Label Alignment check and conformance to quality standards and applicable SOPs as well as applicable ISO and cGMP requirements