- 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
- Eisai, Inc (Raleigh, NC)
- At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care ... 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… more
- SSTAR (Fall River, MA)
- …Statistical Analysis, Quality Management, or related field required. Masters preferred. Healthcare Compliance Certification, preferred. Minimum of 5 years' ... the healthcare or SUD treatment field. Previous quality assurance, compliance , and performance improvement experience required as well as experience working with… 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
- 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
- Essen Medical Associates (Bronx, NY)
- …of the healthcare regulatory industry, with experience in conducting complex compliance investigations . Must have the ability to carry out non-routine ... issues and related opportunities for process improvements. Perform internal compliance investigations and audits throughout the organization, including… 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
- 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. (Durham, NC)
- … compliance with Good Manufacturing Practices and safety.Participates in investigations of automation incidents and problems to prevent recurrence including the ... Environmental Regulations, Environment Health and Safety, Fast-Paced Environments, GMP Compliance , Good Manufacturing Practices (GMP), Healthcare Innovation, IT… more
- Merck & Co. (Rahway, NJ)
- …Facilitate and/or participate in Quality Notification (QN) reporting, investigations , and any related corrective action/preventive action (CAPA).- Facilitate ... comprehensive package of benefits.- Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement… more
- Merck & Co. (Rahway, NJ)
- …comprehensive package of benefits.- Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement ... consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents… 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
- Merck & Co. (Rahway, NJ)
- …in interpreting trends from commercial process monitoring, driving further investigations and process improvements that elevate our standards.Engage Across ... team that is dedicated to advancing the future of healthcare . You'll have the opportunity to work on an...applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los… more
- Summa Health (Akron, OH)
- …preferred. 2. Experience & Training Required: a. Minimum of five (5) years of healthcare compliance or legal experience in a healthcare -provider environment ... Bachelor's degree. Four (4) years of experience with a Master's degree. b. Certified in Healthcare Compliance (CHC) is required. c. One or more of the following… 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
- Merck & Co. (Rahway, NJ)
- …systems within remit including: Monitor user support cases, ensuring proper investigation are conducted, CAPAs detailed and closed effectively and communication is ... Identify and design improvement opportunities within the Support Model to reduce compliance risk and increase efficiency for the Support Team and End Users.… more
- AUROBINDO (Durham, NC)
- …manufacture, we have a robust pipeline of products. Aurolife's aim is to provide healthcare at economical prices to make this a healthier world to live in.Job ... training, on-boarding, orientation, policy implementation, compensation, and employment law compliance .Manage and conduct the new hire orientation and exit interview… more
