Overview Summary : The Quality Assurance (QA) Analyst III, under minimal direction, will be responsible for review and/or approval of basic and technical documentation, drafting and reviewing of internal Quality policies and procedures, performing product related activities, performing Quality audit functions, performing product release activities, identifying process and Quality System improvements, and acting as a QA liaison internally and externally. External US Essential Functions: Review and/or approve basic and technical documentation with minimal supervisory oversight to include, but not limited to: Standard Operating Procedures Batch Production Records (completed and approval) Commissioning, qualification and validation protocols and reports Deviation Reports Corrective Action/Preventive Action Plans Technical data review and approval QC data review and approval Drug Substance/Product Reports Trending QA data Draft and review internal Quality policies, procedures and...
Jan 20, 2021
Overview Summary : The Quality Assurance (QA) Analyst III, under minimal direction, will be responsible for review and/or approval of basic and technical documentation, drafting and reviewing of internal Quality policies and procedures, performing product related activities, performing Quality audit functions, performing product release activities, identifying process and Quality System improvements, and acting as a QA liaison internally and externally. External US Essential Functions: Review and/or approve basic and technical documentation with minimal supervisory oversight to include, but not limited to: Standard Operating Procedures Batch Production Records (completed and approval) Commissioning, qualification and validation protocols and reports Deviation Reports Corrective Action/Preventive Action Plans Technical data review and approval QC data review and approval Drug Substance/Product Reports Trending QA data Draft and review internal Quality policies, procedures and...
Overview Summary The Sample Receipt Analyst I, under general direction, will be responsible for performing routine and non-routine support of samples submitted to the Quality Control (QC) Laboratory for evaluation. External US Essential Functions: Writes and revises Standard Operating Procedures (SOPs) and other related Good Laboratory Practices (GLP)/Good Manufacturing Practices (GMP) documentation Manages test samples, critical reagents and reference materials. Manages shipments to external testing facilities and clients. Provides QC support for the Sample receipt for Manufacturing Perform other duties as assigned. Required Skills & Abilities: Ability to follow safety procedures outlined in the Chemical Hygiene Plan. Utilize SDS sheets to properly assess chemical hazards, spill response procedures, and PPE requirements if indicated. Excellent attention to detail. Computer proficiency required. Ability to accurately complete required documentation. Excellent written and oral...
Jan 20, 2021
Overview Summary The Sample Receipt Analyst I, under general direction, will be responsible for performing routine and non-routine support of samples submitted to the Quality Control (QC) Laboratory for evaluation. External US Essential Functions: Writes and revises Standard Operating Procedures (SOPs) and other related Good Laboratory Practices (GLP)/Good Manufacturing Practices (GMP) documentation Manages test samples, critical reagents and reference materials. Manages shipments to external testing facilities and clients. Provides QC support for the Sample receipt for Manufacturing Perform other duties as assigned. Required Skills & Abilities: Ability to follow safety procedures outlined in the Chemical Hygiene Plan. Utilize SDS sheets to properly assess chemical hazards, spill response procedures, and PPE requirements if indicated. Excellent attention to detail. Computer proficiency required. Ability to accurately complete required documentation. Excellent written and oral...
Overview Summary: Provides organization and coordination of company revenue contract to delivery, provides customer proposal and contract review, and Program Profitability tracking. External US Essential Functions:Working knowledge of ongoing contracts as it relates to revenue recognition and invoicing.Maintain program contract and MSA documentation for review.Maintains Resource Planning systems used to track PD resources versus sold Cost Models. Utilize systems to review utilization analysis to facilitate Finance project discussions.Set up new Signed client programs into the Finance and Resource Managment systems.Maintain monthly new signed Contract Trending for management reporting.Maintain and review with Program Management monthly PD Program Profitabilty ($/Hour) trends.Collaborates with Program Managers and other functional groups to understand project and monthly milestone status (including attending any assigned meetings) and impact on financial results and reports variances...
Jan 20, 2021
Overview Summary: Provides organization and coordination of company revenue contract to delivery, provides customer proposal and contract review, and Program Profitability tracking. External US Essential Functions:Working knowledge of ongoing contracts as it relates to revenue recognition and invoicing.Maintain program contract and MSA documentation for review.Maintains Resource Planning systems used to track PD resources versus sold Cost Models. Utilize systems to review utilization analysis to facilitate Finance project discussions.Set up new Signed client programs into the Finance and Resource Managment systems.Maintain monthly new signed Contract Trending for management reporting.Maintain and review with Program Management monthly PD Program Profitabilty ($/Hour) trends.Collaborates with Program Managers and other functional groups to understand project and monthly milestone status (including attending any assigned meetings) and impact on financial results and reports variances...
Overview Summary The Cell Biology Analyst II will be responsible for participating in the Technology Transfer of established methods into the FujiFilm Biotechnologies Diosynth Texas (FDBT) Quality Control Laboratory. External US Essential Functions: Participate in training the QC Bioassay Staff at FDBT in the established release methods. Perform QC analytical testing for GMP release and stability testing as needed. Perform ELISA based methods, cell based assays and qualification of critical reagents methodologies. Execute tech transfer, qualification, and validation protocols as needed. Contribute to writing and revising Standard Operating Procedures (SOPs) and other Good Manufacturing Practices (GMP) documentation as appropriate. Support the establishment of a system for managing test samples, reagents and reference standards. Report excursion/out-of-specification results to QC Departmental management. Assist in the preparation of technical proposals, amendments, reports and...
Jan 20, 2021
Overview Summary The Cell Biology Analyst II will be responsible for participating in the Technology Transfer of established methods into the FujiFilm Biotechnologies Diosynth Texas (FDBT) Quality Control Laboratory. External US Essential Functions: Participate in training the QC Bioassay Staff at FDBT in the established release methods. Perform QC analytical testing for GMP release and stability testing as needed. Perform ELISA based methods, cell based assays and qualification of critical reagents methodologies. Execute tech transfer, qualification, and validation protocols as needed. Contribute to writing and revising Standard Operating Procedures (SOPs) and other Good Manufacturing Practices (GMP) documentation as appropriate. Support the establishment of a system for managing test samples, reagents and reference standards. Report excursion/out-of-specification results to QC Departmental management. Assist in the preparation of technical proposals, amendments, reports and...
Overview Summary : The Information Technology Systems Administrator is responsible for the design, implementation and maintenance of applications, servers and storage systems for business use. As well as providing technical assistance and support to system users. External US Essential Functions: Designs, implements and maintains information systems best suited to the operational needs of the business by consulting with owners, users and information technology staff. Writes documentation and trains users and IT staff on systems and applications. Loads appropriate software packages such as operating systems and applications Setup, configure and maintain hardware for systems. Participates in the customization and adaptation of existing programs to meet users’ Analyzes and documents problems with vendor‐supplied software, and generates documentation for submission of software problems to vendor; contacts outside resources for input into resolving software problems, and applies...
Jan 20, 2021
Overview Summary : The Information Technology Systems Administrator is responsible for the design, implementation and maintenance of applications, servers and storage systems for business use. As well as providing technical assistance and support to system users. External US Essential Functions: Designs, implements and maintains information systems best suited to the operational needs of the business by consulting with owners, users and information technology staff. Writes documentation and trains users and IT staff on systems and applications. Loads appropriate software packages such as operating systems and applications Setup, configure and maintain hardware for systems. Participates in the customization and adaptation of existing programs to meet users’ Analyzes and documents problems with vendor‐supplied software, and generates documentation for submission of software problems to vendor; contacts outside resources for input into resolving software problems, and applies...
