Manufacturing Admin Coordinator

Manufacturing Coordinator

Facilitate and coordinate manufacturing related meetings. Export and import data, create graphs and metrics using excel spreadsheets. Coordinate and partner with manufacturing and quality functions related with the retrieval and delivery of manufacturing related samples, documents, materials, and readiness of bulk drug substance in a multi-product facility. Performs duties under limited supervision and according to standard operating and manufacturing procedures. Collaborate with main operations and support service teams for the upstream organization to create and provide pickup locations and delivery times for in-process samples.

The candidate will be expected to pick-up and deliver GMP documentation from the manufacturing floor and deliver to the appropriate quality function. This includes cleaning forms, equipment use logs, and other GMP forms and documents work according to cGMP and cGDP standards. Supports schedulers in the tracking of portable equipment, work order status, and delivery of equipment to and from the shop floor.

Adheres to established regulations and follows cGMP established by site. Reports abnormalities and deviations in a timely and accurate manner. Adheres to safety standards and identifies unsafe situations/habits and escalates appropriately. Keeps own training on track and is able to obtain required system accesses in a timely manner. Support equipment changeover logistics and QA release of equipment. Order, pick up, and deliver small kanban materials from central inventory.

Unpack ages, sanitizes, and transfers GMP materials such as depth filters onto the shop floor. Assists in discarding soiled filters in the appropriate waste container. Working in a highly regulated environment following all applicable BI and BI Fremont SOPs, OCPs and BGSs for cGMP, EHS and compliance policies. Required to work according to given schedules in a 24/7 shift structure and flexibility to adapt working schedule upon prior given notice.

Strong focus on execution of repeatable tasks with low technical complexity. Requires strong written and verbal communication skills. Ability to work with computer based systems MS Word, Excel, Outlook and sample management system. Strong attention to detail and organizational skills. Strong customer service skills and the ability to maintain confidentiality. Ability to read and understand SOPs and work instructions and document work in a written format applying cGMP standards.

Ability to work independently and collaborate effectively with customers (manufacturing and quality groups). Does not require extensive technical knowledge of manufacturing operations. High school degree + 1 years or more GMP experience, or Associates/bachelors degree or biotechnology with foundational understanding of GMPs and practical application in lab setting.