- 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
- 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 ... as mass spectrometers and other spectroscopic techniques.Collaborate closely with internal company sites and Contract Manufacturing Organizations (CMOs) within the… 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 ... and containment of the event, address comments from both internal and external clients on the compiled final report....to determine the most likely cause of the deviation investigation , assessment of event for impact to Safety Identity… more
- Repligen (Waltham, MA)
- …9001 for all aspects of the QMS including but not limited to Internal and External Auditing, Nonconforming Materials, CAPA, Validation, Change Controls, and other ... the Senior Management team.Facilitate operational excellence initiatives in Quality Assurance.Maintain internal and external audit schedules; serve as host for site… 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
- Eisai, Inc (Raleigh, NC)
- …assurance functions, supporting regulatory inspections, and collaborating with internal and external stakeholders to resolve quality-related issues.Key ... \tReviewing and making disposition decisions for manufactured product batches. \tSupporting investigations and evaluating the impact of deviations or events on… more
- Aequor (Tampa, FL)
- …sampling and testing. Performs microbiology methods and sampling techniques. Performs investigations and completes CAPA in response to laboratory investigations . ... of environment, equipment and facilities. Manages product testing based upon internal and customer specifications. Managing 3rd party laboratory testing 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
- Merck & Co. (Rahway, NJ)
- …as new drug applications, clinical study reports, or publication; andParticipation in internal and joint internal /external research project teams relevant to the ... of the progress of studies of our companies and competitors' drugs and internal and external expert opinion on scientific questions relevant to his/her areas of… more
- Merck & Co. (Rahway, NJ)
- …environment that provides substantial technical responsibility and leadership of internal and external work.The Senior Scientist, Engineering position leverages ... scales.The successful candidate will play a pivotal role in developing internal technical capabilities via mentoring junior staff and enhancing fermentation 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. ... and distribute supplier report cards in a standardized format to internal stakeholders and suppliers.Maintain and update monthly supplier statistics to monitor… 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 ... as required, in a fast paced, matrixed, team environment consisting of internal and external team membersAnalytical thinking with problem-solving skills and the… more
- Merck & Co. (Durham, NC)
- …(with appropriate escalation as required). Resolve Technical Issues ( Investigations , CAPAs, Process Improvements, Source Changes, Technical Transfers, Equipment ... of information disclosure and maintain confidentiality when dealing with multiple internal and external stakeholders.- Supplier Relationship Management - Ability to… more
- Merck & Co. (Rahway, NJ)
- …lists, qualification documentation, calibration documentation, computer system inventories Support internal and external quality audits and maintain laboratory state ... contribute to Standard Operating Procedures (SOP) draftingOriginate and own Investigations and Change Management recordsThe successful candidate must function both… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …global manufacturing network for best-in-class CAR-T product.Work collaboratively with internal and external partners to drive global process platform improvements ... on process platform parameters, unit operations and analytical methods at both internal and external CMO sitesEnsure global records are consistent and maintained to… 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 ... the delegate for the Head of Operations.Establish key stakeholder relationships with internal and external stakeholders. Ability to interact with all levels within… more
- Repligen (Hopkinton, IA)
- …Non-Conforming Material.Reject any non-conforming material and support Root Cause Investigations .Good organization skills and Microsoft Office software to accurately ... communicate continuous improvement opportunities for the quality program for customers internal and external.Maintain clean and orderly work area/ station. Comply… more
- Merck & Co. (Rahway, NJ)
- …in interpreting trends from commercial process monitoring, driving further investigations and process improvements that elevate our standards.Engage Across ... Functions: Actively interact with internal and external partners, representing your functional area on cross-functional teams to foster collaboration and… more
- AUROBINDO (Durham, NC)
- …employee concerns and workplace issues.Assist in resolving conflicts, conducting investigations , and recommending disciplinary actions when needed.Foster a positive ... needs and coordinate learning and development programs.Assist in organizing internal workshops or sourcing external training providers.Additional ResponsibilitiesEnsure compliance… more
- Merck & Co. (Rahway, NJ)
- …and manages situations that are viewed as precedent setting.- Guides internal teams to implement rigorous, innovative, and science-based approaches to regulatory ... Flexible Work Arrangements:HybridShift:Valid Driving License:Hazardous Material(s):Required Skills:Business, Business, Compliance Investigations , Confidentiality, Cross-Cultural Awareness, Detail-Oriented, Document Control Systems, Electronic… more
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