Senior Manufacturing Associate

Company: Integrated Resources, Inc
Location: Cambridge
Posted on: March 18, 2023

Job Description:

Job Title: Senior Manufacturing Associate Job Location: Cambridge, MA. Job Duration: 12 months+ Job Descriptions: With limited Supervision this individual will perform routine and non-routine manufacturing operations at the Manufacturing Facility. Operations including but not limited to work functions in weigh/dispense, solution preparation, formulation, and UF/DF processing. Operates production equipment according to SOPs to produce clinical and/or commercial products. Requires technical capabilities to interact with support groups (Facilities, Process Development, and Validation etc.) to ensure accurate and well managed transfer of process changes. Support floor operations to ensure safety, aseptic operations and compliance are always maintained. Accountabilities This individual will carry out cGMP manufacturing operations utilizing Standard Operating Procedures (SOP) and Batch Records. Responsibilities include: Troubleshoot and resolve process related issues and interact with support groups to ensure production targets are met and product and process comply with GMPs, product licenses and corporate policies. Ensure all operations and documentation conform to GMP standards and that all SOPs and batch records are maintained to reflect current manufacturing methods. Use technical writing skills to own and complete deviations, CAPAs and change controls as required. Identify and implement continuous improvement projects utilizing independent project management skills. Generation and progression of work orders to support GMP operations; coordinates work activities with support teams to minimally impact schedule adherence. Performs MFG documentation requests (batch records, logbooks); Performs review and approval of manufacturing documentation to ensure compliance. Review and revise MFG documentation to support changes or continuous improvement initiatives. Performs work with adherence to site safety procedures and requirements; Generates safety incident reports where applicable. Provides operational support for cross-functional GMP activities such as validation qualifications, maintenance activities, etc. Provides technical training to junior employees develops on the job training requirements for MFG operations. Familiar with SAP system and transactions related with MFG material consumption. Primary Location (Cambridge, Ma); Alternative plant support (ex. Norton, Ma) may be possible depending on candidate availability.

Keywords: Integrated Resources, Inc, Cambridge , Senior Manufacturing Associate, Other , Cambridge, Massachusetts