- Dana-Farber Cancer Institute (Boston, MA)
- …field required. Minimum Experience: + 4 years of quality assurance and cGMP working experience, including 1 year of laboratory experience in a related ... The Cell Manufacturing Quality Specialist III is responsible for managing the...validation plans and completed validations. + Manage the document control system by supporting multidisciplinary teams in developing controlled… more
- US Tech Solutions (Worcester, MA)
- **Duration: 6 months contract** **Description:** We are currently seeking a Chemist II position in Quality Control to join our team. The Chemist II will perform ... laboratory testing within a fast-paced cGMP environment....PLA software experience **Preferred:** + Spectrophotometric concentration determination + Quality Control testing of phase III and… more
- ThermoFisher Scientific (Boston, MA)
- …CAPA and change control + Perform data trending analysis + Perform in- lab experiments as applicable **Education and Experience:** + Bachelor's degree in lab ... research through our PPD clinical research portfolio, our work spans laboratory , digital and decentralized clinical trial services. Your determination to deliver… more
- ThermoFisher Scientific (Boston, MA)
- …research through our PPD clinical research portfolio, our work spans laboratory , digital and decentralized clinical trial services. Your determination to deliver ... quality and accuracy will improve health outcomes that people...commercial programs in analytical CMC areas (eg, registrational CQAs, control strategy, justification of specifications, and comparability studies). +… more
- Takeda Pharmaceuticals (Lexington, MA)
- …and PS + In collaboration with commercial functions, develop and implement strategies to control quality of drug substances and products based on the current ... (PS) with management and oversight of all project-related analytical control topics, development requirements and program milestones including global...Good/ Laboratory /Manufacturing Practice ( cGMP , cGLP) regulations + Harmonization… more
- Astellas Pharma (Westborough, MA)
- …Represent QC in cross functional meetings and provide support/feedback for microbial quality /contamination control of the facility. + Collaboratively develop and ... QC Scientist will be responsible for supporting review of EM and lab test results, technical writing/projects, and training/coaching team members. This role is… more
- Dana-Farber Cancer Institute (Boston, MA)
- …for the performance, organization and oversight of maintenance of the CMCF cGMP cleanroom spaces, equipment and supporting utilities. This position has several key ... issues within the department. + Perform Preventative Maintenance (PMs) on general lab equipment. Perform general repairs that do not require a specialized technician… more
- Catalent Pharma Solutions (Chelsea, MA)
- …dryers include best-in-class GEA Niro SD1, SD4 and SD7, the latter being the largest CGMP unit of its kind for DPI in North America. Catalent Pharma Solutions is ... This individual operates in accordance with environmental, health, safety, and cGMP guidelines. This individual is responsible for the hands-on execution of… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …with methods for achieving and controlling high standards of purity and quality . The successful candidate will be recognized as a technical resource/expert within ... experience with building scale-down equipment and developing innovative advanced process control strategies for both batch and continuous processes. The ideal… more
- Takeda Pharmaceuticals (Lexington, MA)
- …related experience. Prior experience must include: Ensure manufacturing process meets 100% quality by using automation tools control systems (eg Allen-Bradley ... documents and Validation Plans (VPs) for pharmaceutical manufacturing and laboratory equipment; Write and execute qualification protocols for new equipment… more