Stephan T Email & Phone Number

Branchburg, New Jersey, United States

• Participates in the operation of filling, labeling & packaging equipment of varying complexity and in accordance with Production Manufacturing Records, applicable SOPs, and ISO and cGMPs requirements to produce finished intermediates and final kits.• For participation in Filling Operations, job requirements will include ability to perform aseptic gowning and performing all filling tasks in the aseptic environment.• As part of the production team, may perform in-process quality checks for specific quality attributes (Fill Check, Torque check, Vision System Check, Label Alignment Check ect.). Inspects products for defects and conformance to quality standards and applicable SOPs as well as applicable ISO and cGMP requirements.• Assists in completing all necessary production documentation (Production Manufacturing Records) and associated SAP transactions to ensure that all components meet requirements pertaining to lot numbers, expiration dates, intermediates, reconciliation’s, etc.• Cleans work area and decontaminates work surfaces in accordance with defined procedures, and performs duties in accordance with SOPs, QSRs, and all safety regulatory requirements.• As required perform scheduled environmental monitoring activities in the Filling Suites.• As required, performs warehousing activities according to defined procedures, which may include picking, issuing, returns, internal distribution of goods, receiving, shipping, etc.• Other duties as assigned by management.

Newark, New Jersey, United States

Safely transport product and materials from warehouse to designated areas in accordance with Standard Operating Procedures (SOP) and EH&S requirements measurement containers in accordance with Standard Operating Procedures (SOP) and EH&S requirementsComplete necessary documents for accountability and traceability of product following Good Documentation Practices (GDPs); Comply with cGMPs, and company procedures and work instructionsSafely transport product and empty (primarily glass) materials to designated areas for disposal in accordance with Standard Operating Procedures (SOP) and EH&S requirementsDaily/ Bi-Weekly/Monthly cleaning of room and equipment and fill out appropriate preventative maintenance forms and checklists in accordance with SOP' s;Conduct and complete line and room clearances as per established proceduresDaily Supply list for respective area turned into receiving by scheduled timeComply with 5038 guidelines; cGMPs, and company standardsPerform equipment calibration checks and troubleshoot equipment as neededComplete documentation of activities in accordance with established proceduresImmediate notification of product ion management of deviations to establish ed processes or proceduresAssist other areas as needed (cleaning; non -sterile filling; kitting and preparation operations, etc.)

Greater New York City Area

•Proactively maintain the safety and security of the work area, yourself and your co-workers•Conduct standardized physical and chemical tests applicable to a wide range of products.•Provide daily instrument test results and monitor the quality of data by applying instrument data review; refers to work instructions or standard operating procedures, as necessary.•Contribute to the completion of daily sample login responsibilities by receiving, opening, and sorting and entering in sample information.•Collect and enter, or send, test results into the Analysis Laboratory Information Management System .•Support Quality Practices & Guidelines in the facility by compliance with Data Integrity Assurance Framework, Quality Assurance, Statistical Quality Control and other applicable procedures and guidelines.•Maintain integrity of recorded laboratory results.•Maintain work area to facility housekeeping standards.•Conduct preventative maintenance for lab equipment and assist with non-routine instrument repair. •Work together with other team members to provide regular safety and housekeeping inspections. •Secure instrument certifications via the CEM.•Function as a member of team•Contribute to lab quality through quality suggestions and projects and reports findings to the quality committee.•Participate in Loss Prevention Systems Tools activities.•Attend and participate in monthly meetings addressing facility Safety, Security, Health and Environment requirements. •Ensures proper waste handling of chemical and oil waste.•Participates in shift changeover or information transfer via logbook.