Shelby Taylor

Pharmaceutical manufacturing and research co. (Sacramento, CA) seeks qualified professional to maintain, operate and troubleshoot variety of chromatographic and spectroscopic systems including but not limited to GC-MS, LC, and LC/MS/MS/ICP-MS/ICP-AES. Generate study designs/protocols, write and distribute final reports. Review laboratory notebooks, raw data and technical documentation in support of regulatory filings. Send resumes to: HRD, Nivagen Pharmaceuticals Inc., 3050 Fite Circle, Suite 100, Sacramento, CA 95827

Pharmaceutical manufacturing and research co. (Sacramento, CA) seeks qualified professional to design & execute analytical method validation protocols and reports of active pharmaceutical ingredients and drug products (finished products). Work with SOPs for instruments processes and methodologies used to achieve product. Follow Good Laboratory Practices and perform analytical method development and validation for API and finished products. Send resumes to: HRD, Nivagen Pharmaceuticals Inc., 3050 Fite Circle, Suite 100, Sacramento, CA 95827

Pharmaceutical manufacturing and research co. (Sacramento, CA) seeks qualified professional to prepare protocols of analytical method validation / verification and plan the analysis and prepare reports after completion of activities. Handle and track OOS (out of specification) and OOT (out of trend) investigations and prepare investigation reports. Participate in USFDA, EU, TGA, ISO13485 and WHO audits. Adhere to SOPs and review audit trail of QC instruments. Send resumes to: HRD, Nivagen Pharmaceuticals Inc., 3050 Fite Circle, Suite 100, Sacramento, CA 95827

Pharmaceutical manufacturing and research co. (Sacramento, CA) seeks Chemist to develop analytical methods and provide technical support to formulation development. Design, execute, monitor, interpret, and document analytical activities related to method development, validation and technology transfer. Use analytical techniques such as HPLC, GC, dissolution and perform method development and validation for assay, RS & dissolution. Utilize knowledge of identification and characterization of impurities. Send resumes to: HRD, Nivagen Pharmaceuticals Inc., 3050 Fite Circle, Suite 100, Sacramento, CA 95827

Company seeks professional to provide Quality and GMP compliance oversight, Lead audits and interface with customers and regulatory representatives. Perform vendor audits to ensure compliance. Evaluate and qualify vendors of Raw and packaging materials. Review and approve changes in product processes, equipment or any other changes as per SOPs. Review and approve deviations and non-conformances. Implement and manage customer complaints program. Provide training for employees on procedures and policies. Send resumes to: HRD, Nivagen Pharmaceuticals Inc., 3050 Fite Circle, Suite 100, Sacramento, CA 95827

The Quality Validation Specialist would be responsible for reviewing, participating and ensuring facilities, equipment, utilities are fully qualified and performing as designed. In the execution of this position the individual will support the validation program by writing, executing or providing oversight for detailed protocols and reports to document the validation of facility systems, equipment and utilities in compliance with the appropriate regulatory agency validation requirements. This individual will also participate in communicating validation activities during audits by customers and regulatory authorities. The position requires performance with minimal supervision and the ability to identify validation requirements and analyze and resolve the unique situations presented in the commissioning and qualification of a sterile injectable facility. Click Here to Apply

Overview: The project manager should have a strong understanding of pharmaceutical projects including sterile products like vials, PFS, cartridges, and IV bags. They should have firm hands-on experience in execution of sterile projects, concept designing, and basic engineering. They should be well versed in relevant guidelines like cGMP, GSP, GLP, ISO, etc., be a self-starter, motivator, and team player. They will be independently dealing with vendors and suppliers, internal resources apart from project management, scheduling, master planning, project progress reports, and management reporting. Knowledge of site execution, installation, and commissioning is mandatory. Click Here to Apply

Pharmaceutical manufacturing and research co. (Sacramento, CA) seeks qualified professional to prepare protocols of analytical method validation / verification and plan the analysis and prepare reports after completion of activities. Handle and track OOS (out of specification) and OOT (out of trend) investigations and prepare investigation reports. Participate in USFDA, EU, TGA, ISO13485 and WHO audits. Adhere to SOPs and review audit trail of QC instruments. Send resumes to: HRD, Nivagen Pharmaceuticals Inc., 3050 Fite Circle, Suite 100, Sacramento, CA 95827

Pharmaceutical manufacturing and research co. (Sacramento, CA) seeks Chemist to develop analytical methods and provide technical support to formulation development. Design, execute, monitor, interpret, and document analytical activities related to method development, validation and technology transfer. Use analytical techniques such as HPLC, GC, dissolution and perform method development and validation for assay, RS & dissolution. Utilize knowledge of identification and characterization of impurities. Send resumes to: HRD, Nivagen Pharmaceuticals Inc., 3050 Fite Circle, Suite 100, Sacramento, CA 95827

Pharmaceutical manufacturing and research co. (Sacramento, CA) seeks qualified professional to design & execute analytical method validation protocols and reports of active pharmaceutical ingredients and drug products (finished products). Work with SOPs for instruments processes and methodologies used to achieve product. Follow Good Laboratory Practices and perform analytical method development and validation for API and finished products. Send resumes to: HRD, Nivagen Pharmaceuticals Inc., 3050 Fite Circle, Suite 100, Sacramento, CA 95827

Pharmaceutical manufacturing and research co. (Sacramento, CA) seeks qualified professional to maintain, operate and troubleshoot variety of chromatographic and spectroscopic systems including but not limited to GC-MS, LC, and LC/MS/MS/ICP-MS/ICP-AES. Generate study designs/protocols, write and distribute final reports. Review laboratory notebooks, raw data and technical documentation in support of regulatory filings. Send resumes to: HRD, Nivagen Pharmaceuticals Inc., 3050 Fite Circle, Suite 100, Sacramento, CA 95827