- 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
- Merck & Co. (Durham, NC)
- …vaccine capital projects Provide deep SME knowledge for manufacturing investigations support (Product and process deviations and complex material-related) ... of regulatory inspections by presenting and defending technical documentation, investigations , and change controls Evaluate and develop innovative process… 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
- Merck & Co. (Rahway, NJ)
- …transfer to internal and external manufacturing sites, manufacturing investigations , process validation, second generation process development and authoring ... For commercial programs, activities include site-to-site process transfers, manufacturing investigations and trend evaluations, process enhancements, next generation process… more
- Merck & Co. (Rahway, NJ)
- …process development through process tech transfer, scale-up activities, quality investigations , change management, and authoring GMP standard operating procedures ... aseptic processing, equipment, and sterile technique.Experience in leading quality investigations and change management.Familiarity with United States and European… more
- Merck & Co. (Rahway, NJ)
- …Facilitate and/or participate in Quality Notification (QN) reporting, investigations , and any related corrective action/preventive action (CAPA).- Facilitate ... an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and… more
- Merck & Co. (Rahway, NJ)
- …contribute to Standard Operating Procedures (SOP) draftingOriginate and own Investigations and Change Management recordsThe successful candidate must function both ... an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and… more
- Merck & Co. (Rahway, NJ)
- …an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and ... applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin,… more
- Merck & Co. (Rahway, NJ)
- …Practices (cGMPs), and participating in risk assessments, deviation investigations , and Good Documentation Practices (GDPs).- Position Qualifications :Education ... an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and… more
- Merck & Co. (Durham, NC)
- …an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and ... applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin,… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …first time), schedule adherence, and productivity improvements.Support manufacturing investigations , support and manage change controls, and maintain permanent ... of paid parental leave after just three months of employment , and a paid time off policy that includes...inclusive workforce. It is Legend's policy to ensure equal employment opportunity without discrimination or harassment based on race,… more
- Merck & Co. (Rahway, NJ)
- …regulations and processes.- It is expected that this role will lead significant investigations or events directly, and mentor and coach their team to provide ... an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and… more
- Merck & Co. (Rahway, NJ)
- …in interpreting trends from commercial process monitoring, driving further investigations and process improvements that elevate our standards.Engage Across ... an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and… more
- Merck & Co. (Durham, NC)
- …to ensure compliance with Good Manufacturing Practices and safety.Participates in investigations of automation incidents and problems to prevent recurrence including ... an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and… more
- AUROBINDO (Durham, NC)
- …of absence, training, on-boarding, orientation, policy implementation, compensation, and employment law compliance.Manage and conduct the new hire orientation and ... employee concerns and workplace issues.Assist in resolving conflicts, conducting investigations , and recommending disciplinary actions when needed.Foster a positive… more
- Merck & Co. (Durham, NC)
- …for SAP transactions, validation testing support, supporting root cause investigations and change control activities. Actively supports, participates and embraces ... an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and… more
- Merck & Co. (Durham, NC)
- …for SAP transactions, validation testing support, supporting root cause investigations and change control activities. Actively supports, participates and embraces ... an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …position carries out routine QC testing and may support sampling, investigations , validations, projects and other related support activities for the manufacturing ... or method verification/validation activities Participates in deviations and laboratory investigations Update standard operating procedures with help Delivers training… more
