- Merck & Co. (Rahway, NJ)
- …include but are not limited to: Lead and oversee analytical investigations with a strong focus on quality and regulatory compliance.Excel in ... the company to enhance overall capabilities.Report to the SAS E2E Investigation Support lead.Bring a strong technical background combined with superior… more
- Aequor (Houston, TX)
- …for all Level I key accountabilities: o Responsible for the initiation, investigation and completion of Minor process deviations o Demonstrates technical writing for ... Cause Analysis (RCA) to determine the most likely cause of the deviation investigation o Familiarity with cGMP quality systems, and demonstrates ability to read and… more
- Tris Pharma (Monmouth Junction, NJ)
- …projects regularly reporting status/issues to management, conducts laboratory investigations and recommends appropriate Corrective Action Preventive Action ... studies to support MV, method transfer and complex technical investigations and assists and trains lower level scientists.Responsibilities:Carries out… more
- Aequor (Houston, TX)
- …The Deviation Investigator/Initiator Level III is responsible for the initiation, investigation and completion of Minor and low/medium severity Major process ... Cause Analysis (RCA) to determine the most likely cause of the deviation investigation , assessment of event for impact to Safety Identity Strength Quality Purity… more
- Merck & Co. (Durham, NC)
- …calibration program, including implementation of new instruments for calibration, investigation into instrument events and continuous improvement by through analysis ... and complete SOP revisions.Lead 8-step problem solving sessions to support investigations and develop appropriate CAPAs which lead to program improvements.Review and… more
- Merck & Co. (Durham, NC)
- …calibration program, including implementation of new instruments for calibration, investigation into instrument events and continuous improvement by thorough ... SOP revisions.Participate in 8-step problem solving sessions to support investigations and develop appropriate CAPAs which lead to program improvements.Review… more
- Repligen (Waltham, MA)
- …ISO 9001 standard.Review and approval of validation plans, deviations, failure investigations and corrective action plans prior to implementation when required. ... Design History Files for the site. Assists with OOS investigations , OOT investigations and NCMR investigations .Completes required actions for identified… more
- Merck & Co. (Rahway, NJ)
- …diverse and complex document types, as required, including deviations, investigations , change records, analytical method validations, method transfers, analytical ... knowledge of Veeva, SAP, Trackwise. Experience with manufacturing and analytical investigations and CAPAs. Current Employees apply HERE Current Contingent Workers… more
- Eisai, Inc (Raleigh, NC)
- …\tReviewing and making disposition decisions for manufactured product batches. \tSupporting investigations and evaluating the impact of deviations or events on ... record review, SOP writing, auditing, batch release functions, deviation investigation and resolution, as applicable) .Familiarity with applicable regulatory… more
- Twist BioScience (South San Francisco, CA)
- …the implementation of preventative actions identified through inspections or incident investigations .Assisting in the investigation of EH&S incidents, gathering ... information, and helping to develop initial corrective actions.What You'll Bring to the Team: Hands-on experience supporting or implementing EH&S programs, ideally within an industrial setting.Strong organizational skills with the ability to manage multiple… more
- Aequor (Tampa, FL)
- …sampling and testing. Performs microbiology methods and sampling techniques. Performs investigations and completes CAPA in response to laboratory investigations . ... Manages change controls effectively. Manages/ supports microbiology projects from production or formulations development dept. Actively participates in customer and regulatory audits as area SME. Develops and executes validation protocols for test methods and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …issue and handles project. This position prepares trainings, supports CAPA investigations , case review, documentation reviews in collaboration with the ICSR ... basis. Management of escalated case processing issues/troubleshooting. Supports CAPA investigations / implementation.ICSR Standards Oversight: Acts as subject matter… more
- Aequor (West Greenwich, RI)
- …specialized laboratory equipment and instrumentation. 5. Participate in laboratory investigations and audits as necessary. 6. Perform general laboratory housekeeping ... activities. 7. Maintain training compliance and proficiency. 8. At all times, comply with safety guidelines, cGMPs/CFRs and other applicable regulatory requirements. Shift: Saturday - Tuesday shift schedule. Skills: Previous lab experience is preferred.Basic… more
- Aequor (East Syracuse, NY)
- …and trending. Provide technical expertise and guidance to support investigations and help troubleshoot analytical operational issues. Identify new analytical ... technologies and opportunities for technical advancements. Support the preparation and review of regulatory submissions related to analytical procedures, method development and validation, specifications, reference standards, extended characterization, and… more
- Repligen (Waltham, MA)
- …a key role in driving supplier accountability, supporting root cause investigations , and ensuring Repligen's supplier network meets regulatory and quality standards. ... This role is based in Waltham, MA, and will report to the Senior Manager of Supplier Quality.Responsibilities Supplier Performance Monitoring and ReportingCollect, analyze, and report on monthly supplier performance data, including quality, delivery, and… more
- Tris Pharma (Monmouth Junction, NJ)
- …product development and analytical method development and supports laboratory investigations and performance of non-routine testing such as method comparisons ... and evaluations.ESSENTIAL FUNCTIONS Primary duties/responsibilitiesCarries out responsibilities in accordance with company policies, Standard Operating Procedures (SOPs) and state, federal and local lawsSets up and operates analytical instruments (ie, High… more
- Aequor (Pearl River, LA)
- …deviations and CAPAs as they occur and provides information during investigations . Other duties as they are required.REQUISITE EDUCATION/SKILLS: High School degree ... with at least 2 years of work experience, or training within a cGMP manufacturing environment General knowledge of cGMP, GDP, SOP's English fluent, both written and spoken Good communication and social skills Basic understanding of the Baculovirus Expression… more
- Merck & Co. (Rahway, NJ)
- …Facilitate and/or participate in Quality Notification (QN) reporting, investigations , and any related corrective action/preventive action (CAPA).- Facilitate ... equipment/system changes, execute periodic reviews and support Quality Management System (QMS) activities.- Interface with site & global engineering and maintenance groups, as well as outside vendor support.-Provide facility engineering support and capital… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …first time), schedule adherence, and productivity improvements.Support manufacturing investigations , support and manage change controls, and maintain permanent ... inspection readiness and actively support regulatory inspections.Lead facility operating review meetings and sponsor various department projects to drive continuous improvements and efficiencies within cell therapy Technical Operations.Support organizational… more
- Merck & Co. (Rahway, NJ)
- …contribute to Standard Operating Procedures (SOP) draftingOriginate and own Investigations and Change Management recordsThe successful candidate must function both ... independently and be able to collaborate in a fast-paced, integrated, multidisciplinary team environment. Strong communications skills and eagerness to adapt and learn are essential attributes. As a member of our team, you will be joining scientific and… more
