CGxPServe

Job Description: We are seeking a highly skilled Lead Clinical Data Manager to join our team on a contract basis. The ideal candidate will have extensive experience in Clinical Data Management (CDM) within the Medical Device or Pharmaceutical industry with deep expertise in Medidata R

Job Description: We are seeking a highly skilled Lead Clinical Data Manager to join our team on a contract basis. The ideal candidate will have extensive experience in Clinical Data Management (CDM) within the Medical Device or Pharmaceutical industry with deep expertise in Medidata R

Roles & Responsibilities: BS or above in computer science/statistics with at least 5 years of SAS experience in major pharma or CRO. Develop SAS coding for generating SDTM ADaM datasets and TLFs to support clinical study analysis. Proficient computer skills across multiple applicatio

Roles & Responsibilities: BS or above in computer science/statistics with at least 5 years of SAS experience in major pharma or CRO. Develop SAS coding for generating SDTM ADaM datasets and TLFs to support clinical study analysis. Proficient computer skills across multiple applicatio

Responsibilities: Implementing process and technology improvements. Process and Cleaning Validation. Equipment Qualification. Collecting monitoring analysing troubleshooting and reporting manufacturing data related to performance in the areas of quality cost and speed/service to mark

Responsibilities: Implementing process and technology improvements. Process and Cleaning Validation. Equipment Qualification. Collecting monitoring analysing troubleshooting and reporting manufacturing data related to performance in the areas of quality cost and speed/service to mark

Job Description: The Chemist is responsible for the coordination and organization of stability or reference standard studies to ensure uninterrupted daily operations associated with procurement dispensing studying analyzing and reporting of those studies while assuring compliance for

Job Description: The Chemist is responsible for the coordination and organization of stability or reference standard studies to ensure uninterrupted daily operations associated with procurement dispensing studying analyzing and reporting of those studies while assuring compliance for

Responsibilities: The primary job responsibility for this position is overseeing the day-to-day functions of the Dentsply Sirona Essential Dental Solutions team. This role develops regulatory strategies for existing new and modified medical devices and other (regulated) products. Thi

Responsibilities: The primary job responsibility for this position is overseeing the day-to-day functions of the Dentsply Sirona Essential Dental Solutions team. This role develops regulatory strategies for existing new and modified medical devices and other (regulated) products. Thi

Responsibilities: Lead projects in compliance with Design Control processes for medical devices. Manage Change Qualification projects collaborating with multi-cultural cross-functional teams (CFTs). Oversee Design Verification Validation and Design Outputs in line with regulatory req

Responsibilities: Lead projects in compliance with Design Control processes for medical devices. Manage Change Qualification projects collaborating with multi-cultural cross-functional teams (CFTs). Oversee Design Verification Validation and Design Outputs in line with regulatory req

Responsibilities: A large pharmaceutical company in Los Angeles is in immediate need of a CQV Engineer for a 12-month project this is an onsite position and is 40 hours/week. The client needs someone with Facilities CQV experience including EMPO Vessel IOV and IOPQ including mixing a

Responsibilities: A large pharmaceutical company in Los Angeles is in immediate need of a CQV Engineer for a 12-month project this is an onsite position and is 40 hours/week. The client needs someone with Facilities CQV experience including EMPO Vessel IOV and IOPQ including mixing a

Responsibilities: Prepare and present structured technical documentation and summaries for internal and external stakeholders. Lead the development documentation and maintenance of Design Control elements including User Needs Design Inputs/Outputs DV protocols test cases and reports.

Responsibilities: Prepare and present structured technical documentation and summaries for internal and external stakeholders. Lead the development documentation and maintenance of Design Control elements including User Needs Design Inputs/Outputs DV protocols test cases and reports.

Job Description: We need: A senior CSA (Computer Software Assurance) SME with GAMP 5 GxP and 21 CFR Part 11 standards. Candidates need to have previous experience in the GxP industry or a life sciences industry is required as well as technical competency in FDA regulations. They must

Job Description: We need: A senior CSA (Computer Software Assurance) SME with GAMP 5 GxP and 21 CFR Part 11 standards. Candidates need to have previous experience in the GxP industry or a life sciences industry is required as well as technical competency in FDA regulations. They must

Job Description: Ability to work in a team setting within Design Quality and cross-functionally. Provide leadership in all areas of the Quality System including but not limited to corrective and preventive actions product complaints post market surveillance nonconforming materials ri

Job Description: Ability to work in a team setting within Design Quality and cross-functionally. Provide leadership in all areas of the Quality System including but not limited to corrective and preventive actions product complaints post market surveillance nonconforming materials ri

Job Description: Demonstratable Experience in Computer System Validation (CSV) Experience in software development processes (SDLC) and software testing life cycle (STLC) Experience in drafting reviewing revising and maintaining validation documents (CSV) including Compliance Analysis

Job Description: Demonstratable Experience in Computer System Validation (CSV) Experience in software development processes (SDLC) and software testing life cycle (STLC) Experience in drafting reviewing revising and maintaining validation documents (CSV) including Compliance Analysis

Job Description: Developing Quality Documents. Small Molecule Manufacturing. The Senior Specialist is recognized as having a functional knowledge in the principles and application of quality assurance and regulatory compliance. The Senior Specialist ensures timely delivery of activit

Job Description: Developing Quality Documents. Small Molecule Manufacturing. The Senior Specialist is recognized as having a functional knowledge in the principles and application of quality assurance and regulatory compliance. The Senior Specialist ensures timely delivery of activit

Responsibilities: The Regulatory Affairs Manager will draft and file documentation and submission materials for new and/or existing products to regulatory authorities in support of global product registrations. Regulatory Strategy Development: Develop and implement regulatory strateg

Responsibilities: The Regulatory Affairs Manager will draft and file documentation and submission materials for new and/or existing products to regulatory authorities in support of global product registrations. Regulatory Strategy Development: Develop and implement regulatory strateg

Job Description: The Protein Science group within Biologics and Genetic Medicine is seeking a motivated Scientist with hands-on experience in protein characterization and LC-MS based bioanalysis. The successful candidate will contribute to the development and implementation of advan

Job Description: The Protein Science group within Biologics and Genetic Medicine is seeking a motivated Scientist with hands-on experience in protein characterization and LC-MS based bioanalysis. The successful candidate will contribute to the development and implementation of advan

Responsibilities: Provide clinical programming expertise to support clinical trials global filings regulatory queries data collection and cleaning. Provide input from statistical programming to support clinical trials global filings regulatory queries labelling and payer analyses as

Responsibilities: Provide clinical programming expertise to support clinical trials global filings regulatory queries data collection and cleaning. Provide input from statistical programming to support clinical trials global filings regulatory queries labelling and payer analyses as

Responsibilities: Review protocols for CDISC conformance. Review Case Report Forms and eCRFs with CDISC CDASH and SDTM conformant elements. Write and manage SAS code for mapping clinical data to SDTM data structures in conformance with Emmes SDTM Implementation Guide project standard

Responsibilities: Review protocols for CDISC conformance. Review Case Report Forms and eCRFs with CDISC CDASH and SDTM conformant elements. Write and manage SAS code for mapping clinical data to SDTM data structures in conformance with Emmes SDTM Implementation Guide project standard

Job Description: The Site IT Lead provides 2nd-level IT support by working with business users and IT subject matter experts to troubleshoot and resolve system issues. This role is responsible for ensuring reliable and secure technology systems for local business operations and suppor

Job Description: The Site IT Lead provides 2nd-level IT support by working with business users and IT subject matter experts to troubleshoot and resolve system issues. This role is responsible for ensuring reliable and secure technology systems for local business operations and suppor

Job Description: The candidate will have the opportunity to help shape data and programming infrastructure drive the adoption of R in a regulated environment gain an in-depth understanding of drug development in a fast-moving industry environment and subject domain knowledge in neuro

Job Description: The candidate will have the opportunity to help shape data and programming infrastructure drive the adoption of R in a regulated environment gain an in-depth understanding of drug development in a fast-moving industry environment and subject domain knowledge in neuro

Job Description: What are the top 3-5 skills experience or education required for this position. Process and Cleaning Validation Experience. Equipment Qualification (IOQ/PQ). Quality System Experience (Veeva Track wise Compliance Wire). Medical Device or Pharmaceutical Experience Req

Job Description: What are the top 3-5 skills experience or education required for this position. Process and Cleaning Validation Experience. Equipment Qualification (IOQ/PQ). Quality System Experience (Veeva Track wise Compliance Wire). Medical Device or Pharmaceutical Experience Req

Job Description: The Packaging Operator is responsible for performing packaging functions such as filling labeling packing and wrapping containers while ensuring compliance with cGMP guidelines. The role involves executing batch record instructions maintaining accurate documentation s

Job Description: The Packaging Operator is responsible for performing packaging functions such as filling labeling packing and wrapping containers while ensuring compliance with cGMP guidelines. The role involves executing batch record instructions maintaining accurate documentation s