Strategically plan for each project milestone to set accurate expectations Identify business goals or problems and perform assessment of feasible solutions; determine how changing business needs will affect the system or product and areas of risk Supervise day to day development work by hosting Stand Up calls and serving as a first line escalation point for all related pr

Experience in QC operation including deviation, OOS/OOT investigation, validation, tech transfer, CAPA, CCR etc and CRO/CTL management experience. Manage analytical testing outsourced to multiple CROs /CMOs. Collaborate with internal and external teams to set priorities, plan activities, monitor progress, make decisions, resolve issues, and identify risks and mitigation p

Procurement Specialist / Financial Management Support Assignment 1 year with the potential to extend Temporary Procurement Specialist / Financial Management Support The Temporary Procurement Specialist / Financial Management Support position within the Data, Technology and Engineering Program Management Office reports directly to the Vice President, Technology Program Man

Supports Network by managing Direct Material Purchase Orders Communicates Purchase Order Requirements to Vendors Partners with Site Operations and Supply Chain Planning to understand material requirements and timing to meet production schedules Utilizes Software and Tools to order, track and communicate material readiness Review Supplier Open Order Reports, tracks materia

Grant Specialist Job Title Temporary Grant Specialist Assignment Temp until the end of 2021 and PERM in 2022 Location 100% remote (this role will always be remote) and open to nonlocal candidates (no west coast candidates due to the team working with international employees) Details Bachelors Degree preferred with 2 3 years of relevant experience Coordinates and helps pre

In addition to Quality Associate Responsibilities Independently manages the full life cycle of the Document Control processes including Maintain GXP archives, including receipt, processing and storage of GXP records. Facilitate the lifecycle of controlled documents in the electronic document management system (document creation, revision, issuance, and obsolescence) CMC D

Senior Systems Supply Chain Manager The Supply Chain Systems Senior Manager is responsible for the maintenance of day to day data in Oracle and other business critical systems. As a teaching role, the Supply Chain Systems Senior Manager will conduct new hire training along with upgrade training. Working cross functionally with various internal teams, the Supply Chain Syst

Key responsibilities include The responsibilities of this position include, but are not limited to, the following Support the active management of metrics program and Quality data analytics activities. Support Data acquisition from all applicable systems and create visualizations for Quality leadership team meetings Create ad hoc data models, reports and analysis as neede

Design and development of equipment, processes, and control systems, used for production and assembly of cell encapsulation devices. Manage the evaluation and selection of new equipment/technologies or modifications to existing systems to consider new processing technologies. Support ongoing optimization and improvement in equipment/systems/processes for long term robustn

Manufacturing Specialist Category Life Science Employment Type Direct Hire Reference BH 355559 3 Manufacturing Specialist Biotech, Pharmaceutical (drug product/substance environment) Experience required Writing quality indicators including Deviations, CAPAs and change controls for all phases of manufacturing Expert knowledge of cGMP regulations, ensure manufacturing readi

Biopharmaceutical Quality Control Planner Category Life Science Employment Type Direct Hire Reference BH 354005 2 Quality Control Planner Biotech or Biopharma Other experience needed for this role Managing sample tracker and scheduling releases, stability testing, method training, method transfers and method qualification / validations Managing and scheduling instrument/e

Mentor and develop staff Generate and/or support deviations, OOS, OOT, change controls and CAPA's Establish, revise, review, and maintain procedures including protocol's Review and support equipment validation and method transfer activities Preferred Experience Minimum 5 7 years of GLP/cGMP analytical and/or cell based laboratory experience 2 years of supervisory experien

Responsible for Change Control and Deviation related to QC operations Complete documentation in accordance with Current Good Manufacturing Practices (cGMP) Maintaining QC lab and related systems to ensure compliance with industry standards Participating in equipment validation, method validation Perform sample management such as receipt, inventory, tracking Troubleshootin

Quality Assurance Specialist I Biopharma Manufacturing Operations Category Quality Employment Type Direct Hire Reference BH 354217 1 Quality Assurance Specialist I Biopharma Manufacturing Operations Please note we are looking for candidates with 1 3 years of relevant GMP experience in pharma / biotech organizations as well as experience working in a GMP manufacturing regu

Quality Control Analyst I Category QC Employment Type Contract To Hire Reference BH 356926 Quality Control Analyst I 100% Onsite in Lexington, MA 1st Shift Contract with perm potential Pay rate $35 $37.00 per hour Candidates must have QC experience in a GMP environment Please note, this is not a Senior role . We're looking for candidates with 1 2 years' experience in a GM