2nd Shift GMP Manufacturing Associate (Biotech)

Creative Solutions Services, LLC; Fremont (CA); On-site; USD 42,000 - 54,000; Full time

Job summary

Creative Solutions Services, LLC is seeking an entry-level Manufacturing Associate I for the 2nd shift in Fremont, CA. The role focuses on routine operations in assembly and packaging of drug products in a regulated facility.

You will support Sr./Master associates, help troubleshoot equipment, and ensure proper documentation, calibration, and 5S housekeeping. Shift runs Monday–Friday, 2:00 PM–10:30 PM, with strict safety and SOP adherence.

Qualifications

• High School diploma with at least 1 year of GMP-regulated industry experience.
• Experience in biotechnology/pharmaceutical environments is strongly preferred.

Responsibilities

• Executes routine unit operations in Manufacturing Assembly and Packaging for drug product in a multi-product facility.
• Performs duties under limited supervision according to SOPs and manufacturing procedures.
• Assists Sr. Associate and Master Associate in assembly and packaging in designated areas.
• Supports equipment troubleshooting and changeovers.
• Assists with setup of automated autoinjector, pre-filled syringe, and semi-automated tabletop machines; retrieves tools and parts as needed.
• Maintains documentation in batch records and SOP attachments; reports to production supervisor.
• Performs room cleaning and waste disposal per safety requirements; maintains cleanliness (5S).
• Ensures equipment calibration verification and accurate logbooks.
• Performs assembly, packaging operations and assists in visual inspection/filling.
• Ensures components and supplies are stocked prior to operations.
• Moves product and components within assembly and CNC areas; hand-offs during shift changes.

Skills

Organized

Teamwork

Math skills

Attention to detail

Communication

GMP experience

Biotech familiarity

MS Office knowledge

Education

High School diploma

Associate/Bachelor's degree preferred

Tools

MS Office

Job description

Creative Solutions Services, LLC is seeking an entry-level Manufacturing Associate I for the 2nd shift in Fremont, CA. The role focuses on routine operations in assembly and packaging of drug products in a regulated facility.

You will support Sr./Master associates, help troubleshoot equipment, and ensure proper documentation, calibration, and 5S housekeeping. Shift runs Monday–Friday, 2:00 PM–10:30 PM, with strict safety and SOP adherence.