Manufacturing Associate I

We are looking for Manufacturing Associate I for our client in Fremont, CA.

Job Title: Manufacturing Associate I

Job Location: Fremont, CA

Job Type: Contract

Job Overview:

Pay Range: $19.52hr - $24.52hr

Requirement/Must Have:

• High School degree plus minimum 1+ years work experience in GMP regulated industry.
• Demonstrated mathematical skills, including the ability to perform addition, subtraction, multiplication, division, and conversions.
• Detail oriented with the ability to read, comprehend, and follow written instructions.
• Strong verbal and written communication skills.
• Ability to work in a team environment.
• Experience in related GMP environment within biotechnology/pharmaceutical industry strongly preferred.
• Ability to learn and perform basic computer operations such as MS Office, Outlook, and other computer-based software.
• Must obtain and maintain qualifications, as required, to perform the assigned work.
• Must understand and adhere to all SOPs, company Policies, Procedures, and proper documentation practices in accordance with cGMPs.

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.
• Assists in performing assembly and packaging in designated functional manufacturing area.
• Supports with troubleshooting to equipment.
• Assists in the setup of the automated autoinjector assembly machine, pre-filled syringe assembly machine and semi-automated tabletop machine.
• Retrieves components and equipment from storage.
• Assists with the equipment changeover and minor equipment repairs or adjustments.
• Assists with real-time identification and correction of mechanical or component issues.
• Documents all work in controlled documents such as batch records, logbooks, or SOP attachments.
• Assists with room cleaning in production areas, including removal of equipment, room sanitization, and disposal of waste.
• Ensures equipment identified for operations are used and documented, including verification of equipment calibration.
• Performs assembly and packaging operations and assists in visual inspection or filling operations if required.
• Ensures components, materials, and supplies are stocked prior to the start of operations.
• Handles movement of product and components within the assembly and packaging area.
• Maintains production areas according to predefined standards (5s).
• Adheres to safety standards and escalates unsafe situations appropriately.

Nice to Have:

• Associate or Bachelor s degree from an accredited institution or biotechnology vocational training preferred.

Skills:

• BIOTECHNOLOGY.
• EQUIPMENT CALIBRATION.
• DOCUMENTATION.
• COMPUTER OPERATIONS.
• SANITIZATION.
• MS Office.
• Outlook.
• 5s Standards.
• GMP.

Qualification And Education:

• Entry level proficiency in subject matter.
• Demonstrated ability to be organized and work well in small work groups.

Physical Requirements(Due to nature of job, The candidate must have):

• Ability to stand for almost constant periods.
• Ability to walk for almost constant periods.

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• Medical, Dental, and Vision Insurance
• 401(k) Retirement Plan
• Health Savings Account (HSA)
• Disability Insurance (Short-Term and Long-Term)
• Life and AD&D Insurance
• Paid Sick Leave (where required by applicable state or local law)
• Supplemental Insurance Plans
• Identity Theft Protection
• Pet Insurance
• Employee Wellness Programs
• Employee Assistance Program (EAP)
• Career Growth and Professional Development Opportunities