GMP Manufacturing Associate I (2nd shift)

Manufacturing Associate I (2nd Shift) Location: Fremont, CA Openings: 2 Positions Available Shift: 2nd Shift, Monday-Friday, 2:00 PM-10:30 PM Assignment Notes The two workers will start on 8/24/2026 and end on 12/30/2026 . However, they will start again on 1/4/2027 and go until 12/30/2027 . There will be a shut-down in late December. Job Responsibilities Executes routine unit operations in Manufacturing Assembly and Packaging as assigned related to the manufacturing of drug product in a multi-product facility. Performs duties under limited supervision and according to standard operating and manufacturing procedures. This position is responsible for assisting the Sr. Associate and Master Associate in performing assembly and packaging in designated functional manufacturing area. Support with troubleshooting to equipment. Assists in the setup of the automated autoinjector assembly machine, pre-filled syringe assembly machine and semi-automated tabletop machine. This assistance includes tasks such as gathering tools, machine parts and documents required for such activities. Retrieves components and equipment from storage. Assists with the equipment changeover. Assists with minor equipment repairs/adjustments. Assists with real-time identification and correction of problems. Problems may include, but are not limited to mechanical issues and component issues. Performs all work in accordance with Company Policies and Procedures. All work is documented in controlled documents (batch records, logbooks or SOP attachments) in accordance with SOP. All activities are to be documented in the batch record. All events are to be recorded in the batch record and brought to the attention of the production supervisor for further action. Assists with room cleaning in production areas. Will transfer rubbish to the transfer zones and may empty transfer zones of rubbish when required. This includes removal of equipment, room sanitization and disposal of waste according to established safety requirements. Responsible for following controlled documents to ensure that the equipment identified for operations are used and documented. This includes verification of equipment calibration. Completes logbooks, as required. Responsible for performing assembly and packaging operations and assisting in visual inspection/filling operations, if required. Ensures components, materials and supplies are stocked prior to the start of the assembly and packaging operations. Movement of product and components within the assembly and packaging area. Transfer product, components and equipment within the CNC area. Communication and hand-off to relief personnel during shift change as appropriate. Maintains production areas according to predefined standards (5S). Adheres to safety standards, identifies unsafe situation/habit and escalates appropriately. Required Skills Demonstrated ability to be organized and work well in small work groups. Demonstrated mathematical skills, including the ability to perform addition, subtraction, multiplication, division, and conversions. Detail oriented. Demonstrated ability to read, comprehend, and follow written instructions. Demonstrated written and verbal communication skills are required. Must be able to work in a team environment. Experiences in related GMP environment within biotechnology/pharmaceutical industry strongly preferred. Must be able to learn and perform basic computer operations such as MS Office and Outlook and other computer-based software. Physical Demands / Surroundings: Requires physical activity such as almost constant standing and walking. Works regularly under desirable conditions with some moderately disagreeable conditions in the manufacturing setting. Temperaments/Mental Requirements: The position requires concentration as errors might cause minor to moderate delays, confusion, or expense to correct. The position has some contact with other departments and the associate must be able to discuss issues and ideas with an open mind and even temper. Level of Proficiency: Entry level in subject matter. Attendance / Schedule: The schedule is dependent on the shift for which the associate is hired. Attendance requirements are based on general attendance policies. To Remain in This Position, Employees Must: Obtain and maintain qualifications, as required, to perform the assigned work. Understand, be held accountable for, and adhere to all SOPs, company Policies and Procedures. Adhere to proper technique, proper documentation practices, and all other aspects of cGMPs. Education & Experience Required High School degree plus minimum one (1) year work experience in GMP regulated industry. Preferred Associate/Bachelor's degree from an accredited institution or biotechnology vocational training preferred.

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