Engineering Support Specialist

* Participate in or manage Quality Notification investigations and change management activities* Order process consumables used in GMP manufacturing activities* Submit requests for supply chains to Third Party Quality Management.* Research and manage supplier notifications at the direction of the supplier notification lead.* Prepare, Review, and update GMP Documentation (i.e. Standard Operating Procedures, Bills of Materials, Batch Records)* Content expert and trainer for select procedures* Data entry and electronic log creation and management* Assist with PAS-X administrative work (i.e. parameter value list (PVL) updates/ Change Controls/ Manufacturing Order (MO) creation, coordinating QA approval)* Assist with warehouse coordination (i.e. scheduling sampling, risk release management, deliveries, SAP management)* Assist with equipment troubleshooting and calibration coordination* Work with team members in identification and implementation of continuous improvement initiatives* Support safety, compliance, and GMP initiatives including conducting area walkthroughs and managing/closing observations* Some overtime (including weekends) and occasional second shift work may be necessary. Carrying an on-call phone to support off-hour manufacturing will be required.* This is a developmental role with an opportunity to build a foundation into a front-line manager position.* Knowledge of current GMP regulations.* Work both independently and in a team setting.* Demonstrated ability to manage multiple tasks and priorities.* Effective problem-solving skills.* Effective technical communication skills.* Good comprehension of Microsoft Office Applications, including SharePoint and Power Platform Tools.* Experience with SAP.* Knowledge of PAS-X Manufacturing Execution Systems.* Knowledge of Ariba system.* Knowledge of the Electronic Supplier Transparency Request system.* Knowledge of ETQ Reliance system for supply chain notifications.* Experience working within a Union Environment.* Has worked in relevant manufacturing or processing (aseptic/sterile, bulk, solid oral dosage, packaging, etc.).**Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
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