- Tris Pharma (Monmouth Junction, NJ)
- …coordinates and advances required documentations, in liaison with Product Development (PD)/ Quality Assurance (QA)/ Quality Control (QC)/Regulatory Affairs, ... Tris Pharma , Inc. (www.trispharma.com) is a leading privately-owned biopharmaceutical...Jersey, Tris has an immediate opening for a Method Validation R&D Senior Scientist ISummary:The Method Validation … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Digital Transformation (DX) strategy, regulatory compliance framework, and overall quality assurance standards. This role collaborates with cross-functional ... Preferred Experience10+ years of experience in GxP-regulated IT system implementation, validation , and compliance in pharma /biotech/medical device industry -… more
- Catalent Pharma Solutions (Harmans, MD)
- …systems + Ability to work in fast paced environment supporting the quality assurance /facilities/engineering departments of a CMO for Phase I/II/III GMP ... **Lead Specialist, QA Validation & Engineering** Catalent Pharma Solutions...and cold storage warehousing. The **Lead Specialist, QA - Validation & Quality Engineering** is responsible for… more
- Catalent Pharma Solutions (St. Petersburg, FL)
- …equipment used in the manufacture of drug product intended for human consumption. This validation group within the Quality Assurance department oversees all ... to the implementation of relevant projects and their potential impact on product quality and GMP/GLP. The validation department is responsible for ensuring that… more
- Catalent Pharma Solutions (Greenville, NC)
- **Associate Director, Commercial Quality Assurance ** **Position Summary** Catalent, Inc. is a leading global contract development and manufacturing organization ... ideal for orphan or targeted drug development. The Associate Director, Commercial Quality Assurance provides leadership and support in delivering technical… more
- Catalent Pharma Solutions (Somerset, NJ)
- …Provide quality and regulatory oversight of the design, development, validation , implementation and ongoing maintenance and use of computerized GxP systems and ... **INTERNET POSTING** ** ** **Job Title:** Manager Computer System Validation and Data Integrity **City:** Somerset **State** : NJ...**JOB DESCRIPTION** : Coordinate with project teams, suppliers, site quality and IT teams acting as an expert on… more
- Integra LifeSciences (Plainsboro, NJ)
- …inspections, ISO Certification and surveillance audits and customer audits. + Perform other Quality Assurance and Quality Engineering related duties as ... outcomes and set new standards of care. The **Sr.** ** Quality Engineer - Medical Device / Pharma **...Experience: 6 to 8 years of experience in a Quality Assurance role for medical device or… more
- Catalent Pharma Solutions (St. Petersburg, FL)
- ** Quality Specialist, Data Integrity & GxP Systems Compliance** **Position Summary** Catalent, Inc. is a leading global contract development and manufacturing ... healthier lives. Catalent is dedicated to delivering unparalleled service to pharma , biotech, and consumer health customers, supporting product development, launch,… more
- Catalent Pharma Solutions (St. Petersburg, FL)
- …+ Participates in Product Development/ Validation /Engineering project meetings to provide Quality Assurance input with respect to compliance to cGMP ... The QA Product Manager is responsible for the overall Quality Assurance review and approval of all...projects and Product Development Projects; c) all product process validation and cleaning validation documents; d) all… more
- Catalent Pharma Solutions (San Diego, CA)
- …and company SOPs. Collaboration with Quality Assurance and Quality Control on analytical method validation and compliance issues. + Individuals ... healthier lives. Catalent is dedicated to delivering unparalleled service to pharma , biotech, and consumer health customers, supporting product development, launch,… more
- Catalent Pharma Solutions (Kansas City, MO)
- …showcase good written and verbal communication + Must have a general Quality Assurance knowledge and provide reliable/defendable interpretations of regulatory ... healthier lives. Catalent is dedicated to delivering unparalleled service to pharma , biotech, and consumer health customers, supporting product development, launch,… more
- Catalent Pharma Solutions (Morrisville, NC)
- …of analysis and reports for project deliverables + Work with laboratory operations, quality assurance , and validation functions to assist with administrative ... healthier lives. Catalent is dedicated to delivering unparalleled service to pharma , biotech, and consumer health customers, supporting product development, launch,… more
- Catalent Pharma Solutions (Chelsea, MA)
- …Operations **City:** Chelsea **State** : MA **JOB DESCRIPTION** : Perform various quality assurance checks during all manufacturing processes; Assess regulatory ... use of complex equipment; Assist with protocol and implement validation procedures in accordance with Quality System...years of experience in Related Occupation **RELATED OCCUPATION:** Senior Quality Assurance Specialist or any other job… more
- Catalent Pharma Solutions (Harmans, MD)
- …**Scientist, QC** will oversee the end-to-end contamination control and sterility assurance practices for Catalent's aseptic production process. This position will ... monitoring, compliance to regulations and standard in the subject of sterility assurance and contamination control. The Scientist, QC will work both independently… more
- PCI Pharma Services (Philadelphia, PA)
- …IT Change Requests, UAT, and automated testing frameworks. Champion quality assurance best practices and ensure robust validation of platform functionality ... with business goals while upholding the highest standards of performance, quality , and compliance. **Essential Duties and Responsibilities:** To perform this job… more
- Astellas Pharma (Westborough, MA)
- …The QC Scientist, Microbiology routinely interacts with Manufacturing, QC Analytical, Quality Assurance , and management for microbiological testing and special ... of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in...Author and approve SOP's, protocols, reports, data summaries and quality systems internally as well as at contract labs… more
- Astellas Pharma (South San Francisco, CA)
- …execute automation test protocols. + Interact closely with multiple Astellas teams ( Quality Assurance , Quality Control, Process Development, IT, Facilities, ... want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around… more
- Cambrex High Point (Longmont, CO)
- …a career where You Matter by applying today! Job Overview The Associate Manager of Quality Assurance is responsible for the daily operations of the Quality ... cGMP/cGLP standards and FDA/EU regulations. The Associate Manager of Quality Assurance leads and mentors the ...Experienced with review and approval of equipment and instrument validation as well as associated computer software validation… more
- Bio-Techne (Austin, TX)
- …full companion diagnostic development and commercialization. **Position Summary:** The Advanced Quality Assurance Specialist will work closely with internal ... colleagues as a key member of the Quality Assurance team working to maintain and...quality from the perspective of supplier adds, removals, validation , qualification, classification, audits, and evaluation. + Assists in… more
- ThermoFisher Scientific (Greenville, NC)
- …- North America (DPD-NA) is one of the five divisions that make up the Pharma Services Group. We are made up of approximately 4400 colleagues across six sites who ... background check, which includes a drug screening. **POSITION SUMMARY** The Sterility Assurance Manager is accountable for sterility assurance across site and… more
