Manufacturing Visual Inspection

Planet Pharma; Fremont (CA); On-site; USD 30,000 - 39,000; Full time

Job summary

Planet Pharma is seeking a detail-oriented technician for visual inspection and related duties in a multi-product manufacturing facility in Fremont, CA. You will perform routine unit operations, support drug product filling and packaging, and maintain 5S standards with adherence to cGMP/SOPs.

The role requires strong communication, ability to work with MES, and team collaboration in a fast-paced environment. Associates or Bachelor’s degree preferred; HS diploma with 1+ year experience acceptable.

Qualifications

• 1+ years of experience in a cGMP regulated industry.
• Ability to concentrate on detail-oriented work in a complex technical environment.
• Strong written and verbal communication skills.
• Ability to work with computer-based systems and MES.
• Ability to read and understand SOPs and document work per cGMP standards.
• Ability to work as part of a high-performing team.

Responsibilities

• Executes routine unit operations in Visual Inspection as assigned.
• Performs internal support duties including assisting drug product filling and packaging.
• Maintains production areas according to predefined standards (5S).
• Reports abnormalities and deviations in a timely and accurate manner.
• Adheres to safety standards and escalates unsafe situations.
• Contributes to Quality investigations and corrective actions.

Skills

Detail-oriented

cGMP experience

Strong communication

MES experience

SOP comprehension

Team collaboration

Visual inspection

Education

High school diploma

Associates/Bachelor’s preferred

Tools

MES

Job description

Duties

Executes routine unit operations in Visual Inspection 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. Executes independently with adequate training, complex fundamental operations as visual inspection, advance visual inspection, palletizing, cleaning, inspection hood prep for operations, BioMES Operations and Exceptions. Performs internal support duties including assisting drug product filling and packaging. Executes independently with adequate training fundamental operations:

• Logistics Coordination
• Batch record executions
• Equipment use logs
• Work order initiation and tracking
• Support Projects
• Support Creation/Maintain Training Kits Documents work according to cGMP and cGDP.
• 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.
• Maintains production areas according to predefined standards (5s).
• Maintains own training within compliance and trains other technicians and associates on operations upon completion of trainer qualification.
• Contributes to Quality activities such as supporting investigations, corrective actions and area walk throughs.

Skills

• 1 or more years of experience in cGMP regulated industry.
• Ability to concentrate on detail-oriented work in a complex technical setup with a Quality and “Right the first-time” mindset.
• Strong written and verbal communication skills.
• Ability to work with computer-based systems and manufacturing execution systems (MES).
• Ability to read and understand SOPs and instructions and document work in a written format applying cGMP standards.
• Ability to work as part of a high performing team and collaborate effectively with staff.
• Must be able to read and see clearly.

PHYSICAL DEMANDS

• Duties of this position may require the incumbent to exert some physical effort.
• Lifting requirements may vary dependent on the drug product manufacturing visual inspection area activity. Weight is typically no more than 25 pounds.

Education

• High school degree + minimum 1 year work experience in GMP regulated industry
• Associates/Bachelor’s degree or biotechnology vocational training preferred

Pay Rate Range

$22-28/hr depending on experience