- Merck & Co. (Rahway, NJ)
- …environment.Responsibilities include but are not limited to: Lead and oversee analytical investigations with a strong focus on quality and regulatory compliance ... chainIntroduce and lead strategic initiatives related to technical advancement, compliance , and business improvements.Demonstrate the ability to influence meaningful… 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
- Merck & Co. (Rahway, NJ)
- …procedures, equipment and systems, and/or facilities to ensure the compliance with Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs) ... our company's procedures to assure API manufacturing and testing is in compliance and will gain competency in their responsibilities.-- - Primary responsibilities… more
- Merck & Co. (Durham, NC)
- …leadership skills to empower teams, solve complex technical challenges, and ensure compliance with industry standards while making a tangible impact on our ... calibration program, including implementation of new instruments for calibration, investigation into instrument events and continuous improvement by through analysis… 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)
- …Chromatography & Proteins.ResponsibilitiesThe Director, Quality will be responsible for:Maintaining site compliance to ISO 9001 for all aspects of the QMS including ... serve as host for site auditsMaintain risk-based strategy for overall Quality compliance across the organization and in support of the ISO 9001 standard.Review… more
- Eisai, Inc (Raleigh, NC)
- …The QA Specialist plays a critical role in ensuring the quality and compliance of commercial and clinical products manufactured at the Eisai Raleigh facility. This ... \tReviewing and making disposition decisions for manufactured product batches. \tSupporting investigations and evaluating the impact of deviations or events on… 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 ... waste management services provided by external vendors to ensure compliance and efficiency.Assist with maintenance of programs and other documentation… more
- Merck & Co. (Rahway, NJ)
- …Analytical Research & Development (AR&D) External Capabilities, Validation, and Compliance (ECVC) department of our company's Research Laboratories Division is ... role will include:Partner with scientific teams across AR&D to drive compliance and operational excellence Onboard, qualify, and maintain laboratory equipment and… more
- Merck & Co. (Durham, NC)
- …available which is accountable for all EHS program execution and compliance at our Manufacturing Division's vaccine manufacturing facility in Durham, North ... Carolina.- The Durham EHS Lead influences site leadership ensuring compliance with regulatory requirements, corporate standards, policies, and procedures related to… more
- Repligen (Waltham, MA)
- …growing Supplier Quality team. You will a key role in ensuring the quality, compliance , and performance of Repligen's global supplier base. This is an opportunity to ... a key role in driving supplier accountability, supporting root cause investigations , and ensuring Repligen's supplier network meets regulatory and quality standards.… more
- Merck & Co. (Durham, NC)
- … compliance with Good Manufacturing Practices and safety.Participates in investigations of automation incidents and problems to prevent recurrence including the ... of process control, data collection techniques, and troubleshooting in compliance with SDLC, GMP, safety, and environmental regulations.- Actively support,… more
- Merck & Co. (Rahway, NJ)
- …Driving License:Hazardous Material(s):Required Skills:Business, Business, Compliance Investigations , Confidentiality, Cross-Cultural ... the US and globally to execute efficiently on regulatory obligations, compliance requirements and company strategy.Providing quality advice to stakeholders creating… 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.… 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 needed Cleans, maintains and calibrates laboratory instruments to ensure compliance with current Good Laboratory Practices (cGLPs) and Good Manufacturing… more
- Merck & Co. (Rahway, NJ)
- …Facilitate and/or participate in Quality Notification (QN) reporting, investigations , and any related corrective action/preventive action (CAPA).- Facilitate ... consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents… 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 ... manage performance, and develop talent. Ability to create an engaged workforce.GMP Compliance & Regulatory Knowledge: Deep understanding of FDA, EMA, and other… more
- Merck & Co. (Rahway, NJ)
- …consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents ... License:Hazardous Material(s):Required Skills:Academic Presentations, Biomedical Research, Clinical Development, Clinical Investigations , Clinical Judgment, Clinical Medicine, Clinical Research, Clinical Sciences,… more
- Merck & Co. (Rahway, NJ)
- …will be expected to exhibit a mindset of safety and quality compliance , which will include following current Good Manufacturing Practices (cGMPs), and participating ... in risk assessments, deviation investigations , and Good Documentation Practices (GDPs).- Position Qualifications :Education Minimum Requirement: The position… more
- Aequor (Pearl River, LA)
- …weekends and holidays as required, and as needed by department. Work with Compliance regarding notification of 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… more
