- Logistics Coordination
- Batch record executions
- Equipment use logs
- Work order initiation and tracking
- Support Projects
- Support Creation/Maintain Training Kits Documents work according to c
GMP and cGDP. - Adheres to established regulations and follows c
GMP 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.
- 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 c
GMP standards. - Ability to work as part of a high performing team and collaborate effectively with staff.
- Must be able to read and see clearly.
- 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.
- Employees required to participate and have acceptable result from vision testing including color blindness.
- How many years of experience do you have in
GMP regulated industry? -
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Mechanical Engineering Technician/ Manufacturing Visual Inspection - Fremont, CA, United States - ADIENTONE
Description
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.
Executes independently with adequate training fundamental operations:
Skills:
-1 or more years of experience in c
GMP regulated industry.
PHYSICAL DEMANDS:
Keywords:
Education:
High school degree + minimum 1 year work experience in
GMP regulated industry Associates/Bachelor's degree or biotechnology vocational training preferred
Skills and Experience:
Required
Skills:
BIOTECHNOLOGY
PACKAGING
VISUAL INSPECTION
C
GMP
SOPS
Additional
Skills:
GMP
DETAIL-ORIENTED
VOCATIONAL TRAINING
OPERATIONS
PALLETIZING
SAFETY STANDARDS
BATCH RECORD
EXCELLENT WRITTEN AND VERBAL COMMUNICATION SKILLS LOGISTICS
Languages:
English
Read
Write
Speak
Minimum Degree Required:
Completed High School (Diploma or GED)
Job Type:
Contract
Pay:
From $25.00 per hour
Application Question(s):
Work Location:
In person