cGxPServe

Responsibilities : You will provide technical expertise as an experienced R programmer to develop process methodology ensuring the department meets the needs of both internal and external clients. Responsibilities include planning and coordinating the development of integrated progr More...

Responsibilities: Lead and mentor high-performance teams of Test Analysts/ Engineers in geographically distributed locations effectively to deliver testing-related project deliverables on time on budget and with high quality. Effectively leverage test automation techniques and techno More...

Job Description: This position will be responsible for project management activities around developing and implementing restricted substances management (RSM) regulatory requirements such as EU REACH US Conflict Minerals US Prop. 65 EU Restriction of Hazardous Substances (RoHS) etc. R More...

Responsibilities: Provide programming support for study deliverables as assigned ensuring that timelines are met and expected quality is attained. Liaise with Data Management and Biostatistics for database and dataset specifications timelines and quality requirements. Create and vali More...

Job Description: The main function of a supplier quality engineer is to research and test and develop quality standards for components. A typical quality engineer has the ability to read and interpret blueprints and evaluate component integrity and standards. We are NPD Supplier Qual More...

Job Description: Under limited supervision works collaboratively with vendor Project Managers and Clinical Data Managers to assure that Data Management functions are performed in compliance with regulations and according to study protocol and Study Data Management Manual (DMM). Works More...

Job Description: We are seeking an experienced Lead Clinical Data Manager to oversee and manage all aspects of clinical data management activities for multiple clinical studies. The ideal candidate will ensure the accuracy integrity and quality of clinical trial data while collaborati More...

Job Description: The Senior Statistical Analyst is a key role in the research and development of new pharmaceutical products. The primary responsibilities for this role include the analysis and reporting of clinical trial data and leading the statistical programming activities for cl More...

Responsibilities: Prepare and submit regulatory documentation for domestic and international markets ensuring compliance with applicable regulations (i.e. PMA HDE 510ks letters to file and Tech Docs). Provide regulatory direction to development project teams as a core team member. De More...

Responsibilities: Effectively manage and oversee statistical programming resources including contractors and CROs related to statistical programming deliverables to ensure high-quality within timeline and budget. Conduct hands-on validation/QC of CRO deliverables to ensure high-quali More...

Responsibilities: Develop and maintain all data management documentation including case report forms data management plans edit check specifications data review plans and data transfer agreements. Design case report forms (CRFs) for electronic data capture (EDC) systems for data coll More...

Job Summary: The Pharmaceutical Technician will efficiently effectively and safely clean set-up and operate machinery in the manufacturing area while adhering to applicable cGMPs SOPs FDA and DEA guidelines. Responsibilities: Follow Master Batch Records for the manufacturing of contr More...

Responsibilities: Designing and implementing software of embedded devices and systems. Designing developing coding testing and debugging system software. Develop Requirements based manual test procedures. Access requirements for testability and determine best test approach. Compile More...

Roles & Responsibilities: Medical Device manufacturing experience. Very strong experience in process development & process characterization. Good experience in process validation (IQ OQ PQ). Good experience in test method development & validation. Good experience in PFMEA. Good know More...

Responsibilities: US Agent for all products responsible for communication between the FDA and manufacturing sites. Communicate and follow-up status with FDA for any Chemistry Bioequivalence and Patents issues and correspondences on both pending and approved applications. Lead guide a More...

Responsibilities: Liaise with stakeholders to understand clinical study data aggregation requirements. Use the analytics platform to set up the study for the processing of data from source and/or systems. Load data from EDC and extract into the analytics platform map to SDTM and/or o More...

Job Description: This role is responsible for executing microbiological testing environmental monitoring and method validation in a GMP-regulated laboratory. The candidate supports quality control functions including method development troubleshooting and test execution for raw materi More...

Job Description: Working with the Biometrics staff the candidate will provide programming support for Phase 1 to Phase 3 studies. Providing timely support to the project team on all statistical programming matters according to the project strategy. The candidate programs SDTM/ADaM/ More...

Responsibilities: Previous Cell and Gene therapy experience a must. Elevate Bio is looking for a contractor as a Specialist II to join their growing QA Validation group. This is expected to be a 6-month contract position. The role is expected to be onsite in Waltham MA 3-4 days per w More...

Responsibilities: Develop global regulatory strategies for medical device products to meet business objectives and collaborates across a matrixed organization to ensure global success of products registration. Participate on product development teams providing regulatory strategies t More...