Manufacturing Associate

4 weeks ago


Fremont, United States Fladger Associates Full time

Responsibilities:

- Excellent employment opportunity for a Manufacturing Visual Inspection in the Fremont, CA area.
- 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.

**Experience**:

- High School Diploma + minimum 1 year work experience in GMP regulated industry
- Associates/Bachelor’s Degree or Biotechnology vocational training preferred
- 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 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. - Employees required to participate and have acceptable result from vision testing including color blindness.
- Schedule**: 1st Shift: Monday-Friday, 6:00AM-2:30PM
- Required Skills**: BIOTECHNOLOGY, PACKAGING, VISUAL INSPECTION, CGMP, SOPS
- Additional Skills**: GMP, DETAIL-ORIENTED, VOCATIONAL TRAINING, OPERATIONS, PALLETIZING, SAFETY STANDARDS, BATCH RECORD, EXCELLENT WRITTEN AND VERBAL COMMUNICATION SKILLS, LOGISTICS

**Job Type**: Contract

Pay: $17.00 - $23.00 per hour

**Benefits**:

- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance

Schedule:

- 8 hour shift

**Experience**:

- Manufacturing: 3 years (required)

Shift availability:

- Day Shift (required)

Ability to Commute:

- Fremont, CA 94536 (required)

Ability to Relocate:

- Fremont, CA 94536: Relocate before starting work (required)

Work Location: In person



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