SGS_JOB_1016
Contract - 6 Months+ (Potential Extension)
Accountable for developing and implementing labeling content and strategy for multiple drug development products, including TLPs, CCDS, USPI, and EU SmPC. Manages Labeling Cross-Functional Teams, fostering collaboration and aligning labeling strategy and content. Interfaces with Senior Management (GLOC) to secure labeling approval, ensuring alignment and preparation of GLOC Chair(s) and members. Works closely with the Head of Global Regulatory Affairs Marketed Products and Labeling.
Location (mandatory): Vacaville California With limited supervision, QC Associate I, is responsible for the performance of direct materials testing in accordance with cGMP regulations. These duties include execution of laboratory testing, trend analysis, documentation review, support of discrepancies (OOS, OOT, OOE) and other laboratory support activities. In conjunction with Quality Control leadership, the QC Associate II works to meet departmental and organizational goals.
Location (mandatory): Houston TX The Deviation Investigator/Initiator Level III is responsible for the initiation, investigation and completion of Minor and low/medium severity Major process deviations unassisted, and the supervised completion of high severity Major and Critical process deviations with the aim at identification of root cause, determining Product Quality Impact (PQI) and implementation of corrective actions to prevent recurrence.
Location : Remote We are seeking a detail-oriented and innovative Marketing Healthcare Writer to join our team. This role focuses on creating accurate, engaging, and compliant digital content for diverse promotional channels within the healthcare sector. The ideal candidate will collaborate closely with the marketing team and leverage AI-driven tools to streamline content development while ensuring quality and compliance
Location : Portsmouth NH Validation Engineer II responsible for Computer System Validation (CSV) in a regulated biotech/pharma manufacturing environment, ensuring GMP compliance for automation, process control, and MES systems while supporting site and process improvement initiatives.
Location : Cambridge MA, USA 02142 The Analytical Development team is seeking a highly self-motivated analytical chemist to join us for a 12-month contract. This role will support analytical method development for small molecule and oligonucleotide programs. This position requires expertise in analytical chemistry and extensive experience in analytical techniques such as LC, LC-MS, GC, and GC-MS. The position also requires adequate knowledge of organic chemistry or pharmaceutical science. Hands-on experience with high resolution mass spectroscopy (HRMS) and prep LC would be a plus.
Location: Rockford, IL 61103 Performs a variety of laboratory tasks under the supervision of a Scientist/Researcher. The technician will use both standard procedures and adapted processes to support specific projects and routine operations, while collaborating with maintenance staff to ensure smooth equipment functioning.
Location : Sanford, NC. The Specialist, QA Validation will be primarily responsible for the implementation, execution and assessment of quality systems, procedures, and records to support compliant GMP operations. This position works closely with Validation, Engineering, Manufacturing, Quality Control, Facilities, and Automation.