Manufacturing Associate

Responsibilities:

• Excellent employment opportunity for a Manufacturing Assembly and Packaging in the Fremont, CA area.
• Schedule: 1st Shift:Monday to Friday, 6:00AM-2:30PM
• 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.
• 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, 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 is 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.
• Ensure 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

Experience:

• High School Diploma plus minimum one (1) year work experience in GMP regulated industry
• Associate/Bachelor's Degree from an accredited institution or biotechnology vocational training preferred
• 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, walking.
• Works regularly under desirable conditions with some moderately disagreeable conditions in the manufacturing setting
• 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
• The schedule is dependent on the shift for which the associate is hired. Attendance requirements are based on general attendance policies.
• Must obtain & maintain qualifications, as required, to perform the assigned work.
• Must understand, will be held accountable for and must adhere to all SOPs, company Policies and Procedures
• Must adhere to proper technique, proper documentation practices, and all other aspects of the cGMP's
• This position will require individuals to be fully vaccinated against COVID-19 or have an approved medical or religious accommodation.

Requirements

Manufacturing

Machine Assembling

Troubleshooting

Qualification

High School or equivalent