GMP Manufacturing Technician IIIIII -KIT Lab- Day Shift
GMP Manufacturing Technician IIIIII -KIT Lab- Day Shift
Posted on :
20-12-2024
Employer Active
1 Vacancy
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Job Description
The GMP Manufacturing Technician position is responsible for performing manufacturing activities in compliance with company procedures and external regulatory requirements at the Petaluma and Novato ISO 13485 sites and as directed by the GMP Manufacturing Management.
This will be in our Kit Lab in Novato. Techs do final dry down (lyophilizatoin) column packing for purification aliquoting and kitting of product.
Shift: MondayFriday 5 x 8 hours.
- Perform manufacturing activities according to written protocols as directed by the departmental supervisor manager or director.
- Maintain batch records equipment logs and other production records as directed per company procedures.
- Follow current Good Manufacturing Practices (cGMP) and close adherence to internal SOPs utilizing GDP practices.
- Perform routine operation maintenance inspection and cleaning of equipment in accordance with operational instructions
- Quick and effective diagnosis of routine problems in manufacturing steps
- Initiate attention to operators and tagouts per documented processes
- Execute Deviation and Nonconformance action plans
- Reporting of safety incidents or safety hazards to senior colleagues supervisors or managers
- Maintain a clean an orderly laboratory environment.
Qualifications :
- Bachelors degree in a related STEM field is required.
- 1 year of equivalent industry lab experience and training and/or demonstration of ability to meet the requirements of a GMP Technician.
- Knowledge of HPLC MS Purifiers Spectramax SpeedVacs Liquid Handlers TFF Pipettes experience or knowledge preferred.
- Ability to add subtract multiply and divide all units of measure using whole numbers common fractions and decimals.
- Microsoft Office Outlook Word and Excel use of a web browser Unicorn and Empower a plus.
- Selfmotivated with the ability to work independently as well as on teams
- Professional presence and strong attention to detail is required
- Technical proficiency that enables effective execution of documented procedures
- Able to multitask work in a fastpaced environment.
- Strong communication and problem solving abilities are necessary.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
Key Skills
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