CAPA Lead Batch Reviewer
3 weeks ago
- Lead a team of Batch Record Reviewers performing the following activities: Execute the initiation and/or evaluate deviation(s), interview personnel, analyze root cause, assess impact, identify corrective / preventive actions, present to management and close investigations in the Quality Management System (QMS).
- The Reviewers in this role will be responsible for executing root cause investigations, owning/authoring deviations, driving continuous improvement efforts.
- They will also manage both minor and major investigations as relates to Batch Record reviews.
- Work on a team under a Senior Manager.
- Cell/Gene Therapy experience preferred.
- The Lead Reviewer will also be responsible for reporting to the client management on a weekly basis on review details, project progress and project metrics, as well as providing coaching and training for the staff reviewers.
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Capa Lead Batch Reviewer
1 month ago
Baltimore, United States CENTSTONE SERVICES LLC Full time**Job Title**:CAPA Lead Batch Reviewer **Shift**: Night - Lead a team of Batch Record Reviewers performing the following activities: Execute the initiation and/or evaluate deviation(s), interview personnel, analyze root cause, assess impact, identify corrective/preventive actions, present to management and close investigations in the Quality Management...
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Capa Lead Batch Reviewer
1 month ago
Baltimore, United States Katalyst Healthcares & Life Sciences Full time**Responsibilities**: - Lead a team of Batch Record Reviewers performing the following activities: Execute the initiation and/or evaluate deviation(s), interview personnel, analyze root cause, assess impact, identify corrective / preventive actions, present to management and close investigations in the Quality Management System (QMS). - The Reviewers in...
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CAPA Lead Batch Reviewer
1 day ago
Baltimore, United States Katalyst Healthcares and Life Sciences Full timeResponsibilities: Lead a team of Batch Record Reviewers performing the following activities: Execute the initiation and/or evaluate deviation(s), interview personnel, analyze root cause, assess impact, identify corrective / preventive actions, present to management and close investigations in the Quality Management System (QMS). The Reviewers in this...
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Lead Batch Reviewer
1 month ago
Baltimore, United States Compli Full timeLOCALCANDIDATES ONLY Execute the initiation and/or evaluate deviation(s), interview personnel, analyze root cause, assess impact, identify corrective / preventive actions, present to management and close investigations in the Quality Management System (QMS).. The Reviewers in this role will be responsible for executing root cause investigations,...
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Staff Investigator
1 month ago
Baltimore, United States Katalyst Healthcares & Life Sciences Full time**Responsibilities**: - Lead a team of Quality Investigators performing the following activities. - Execute the initiation and/or evaluate deviation(s), interview personnel, analyze root cause, assess impact, identify corrective / preventive actions, present to management and close investigations in the Quality Management System (QMS). - The Investigators...
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Specialist I, QA Batch Release
1 day ago
Baltimore, United States Emergent BioSolutions Full timeWe go where others won’t, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life. I. JOB SUMMARY The...
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Specialist I, QA Batch Release
13 hours ago
Baltimore, Maryland, United States Emergent BioSolutions Full timeWe go where others won't, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life.I. JOB SUMMARY The QA...
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Quality Assurance Investigator
1 month ago
Baltimore, United States Compli Full timeProvide consulting services in aseptic processing. The consultant will perform investigations as relates to sterile manufacturing processes that utilize Isolator technology. Client is requiring isolator technology and aseptic fill experience. Work on a team under a Senior Manager. Min 7 years’ experience. Isolator experience helpful. Excellent tech writing...
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HCG Quality Engineer
3 weeks ago
Baltimore, United States Horizon Controls Group Full timeBaltimore, United States | Posted on 04/26/2024 As the Quality Engineer, you are responsible for product quality assurance and quality engineering. You will provide technical oversight and maintain quality systems that are effective and comply with federal, state, local, and other applicable international regulations, and standards. You will also ensure...
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Manager, Aseptic Operations
3 weeks ago
Baltimore, United States Germer International - Pharmaceutical Recruiting Full timeManager, Aseptic Operations BASIC FUNCTION:Provides direction and leadership to the Company's operations with oversight of Aseptic Manufacturing (formulation and filling) operations. This position works closely with all levels of Operations (Manufacturing and Finishing), Quality Assurance, Technical Services, Validation, QC (Microbiology and Analytical...
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Manager, Aseptic Operations
3 weeks ago
Baltimore, United States Germer International - Pharmaceutical Recruiting Full timeManager, Aseptic Operations BASIC FUNCTION:Provides direction and leadership to the Company's operations with oversight of Aseptic Manufacturing (formulation and filling) operations. This position works closely with all levels of Operations (Manufacturing and Finishing), Quality Assurance, Technical Services, Validation, QC (Microbiology and Analytical...
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Manager, Aseptic Operations
2 days ago
Baltimore, United States Germer International - Pharmaceutical Recruiting Full timeManager, Aseptic Operations BASIC FUNCTION:Provides direction and leadership to the Company's operations with oversight of Aseptic Manufacturing (formulation and filling) operations. This position works closely with all levels of Operations (Manufacturing and Finishing), Quality Assurance, Technical Services, Validation, QC (Microbiology and Analytical...
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Clinical Review Nurse
3 weeks ago
Baltimore, Maryland, United States Johns Hopkins Medicine Full timeJohns Hopkins Care at Home (JHCH) is a leading provider of home care services, committed to delivering high-quality, patient-centered care. We are currently seeking a dedicated and experienced Clinical Review Nurse (CRN) to join our team. Collaborate with clinical staff and other team members to foster a culture of continuous improvement in documentation...
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Clinical Review Nurse
3 weeks ago
Baltimore, United States Johns Hopkins Medicine Part timeJohns Hopkins Care at Home (JHCH) is a leading provider of home care services, committed to delivering high-quality, patient-centered care. We are currently seeking a dedicated and experienced Clinical Review Nurse (CRN) to join our team. Collaborate with clinical staff and other team members to foster a culture of continuous improvement in documentation...
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Clinical Review Nurse
3 days ago
Baltimore, Maryland, United States Johns Hopkins Medicine Full timeJohns Hopkins Care at Home (JHCH) is a leading provider of home care services, committed to delivering high-quality, patient-centered care. We are currently seeking a dedicated and experienced Clinical Review Nurse (CRN) to join our team. Collaborate with clinical staff and other team members to foster a culture of continuous improvement in documentation...
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Clinical Review Nurse
1 day ago
Baltimore, United States Johns Hopkins Medicine Part timeJohns Hopkins Care at Home (JHCH) is a leading provider of home care services, committed to delivering high-quality, patient-centered care. We are currently seeking a dedicated and experienced Clinical Review Nurse (CRN) to join our team. Collaborate with clinical staff and other team members to foster a culture of continuous improvement in documentation...
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QA Specialist
3 days ago
Baltimore, United States Katalyst Healthcares & Life Sciences Full timeResponsibilities: Oversee revision, development and tracking of controlled documents. Manage full life cycle of all controlled documents in the EDMS system including document creation, archival, and revisions. Maintain all document management files in the EDMS system. Responsible for issuing batch records, logbooks, and other...
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Quality Engineer
2 weeks ago
Baltimore, United States Katalyst Healthcares and Life Sciences Full timeResponsibilities : This consultant will be responsible for assisting with integration and remediation efforts from audit findings that need to be addressed from a prior acquisition. This candidate should be comfortable in a jack-of-all-trades quality engineering perspective, specifically focused on manufacturing support and supplier quality support, as...
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Baltimore, United States PeopleSuite LLC Full timeScope of PositionThe Aseptic Manufacturing individual supervises the daily operations of a manufacturing area and ensures that all department operations are accomplished in compliance with cGMP/ISO regulations and meet production standards.ResponsibilitiesAdministrative Job Task- Time card management, personnel coaching, development, responsible for...
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Baltimore, United States PeopleSuite LLC Full timeScope of PositionThe Aseptic Manufacturing individual supervises the daily operations of a manufacturing area and ensures that all department operations are accomplished in compliance with cGMP/ISO regulations and meet production standards.ResponsibilitiesAdministrative Job Task- Time card management, personnel coaching, development, responsible for...