Senior Manufacturing Specialist

2 weeks ago


Sunnyvale, California, United States V R Della Infotech Inc Full time
Job Overview

Position Title: Senior Manufacturing Specialist


Position Summary:
This role focuses on the formulation of various buffers and basic bulk reagents in accordance with established manufacturing protocols while operating with minimal oversight. The individual will engage in initiatives aimed at enhancing process efficiency.


Core Responsibilities:
1. Review and verify all documentation pertinent to the area of responsibility.
2. Oversee the WNS (Work Notification System).
3. Assist in the production of controls and calibrators, ensuring accurate completion of batch records in compliance with cGMP standards.
4. Conduct in-process assays utilizing instruments such as spectrophotometers, pH meters, and clinical analyzers.
5. Execute weighing, transferring, and mixing of necessary chemicals.
6. Perform product filtration processes.
7. Clean and perform steam sterilization of stainless steel tanks (CIP/SIP).
8. Prepare glassware and stainless steel tanks for sterilization in an autoclave and operate the autoclave.
9. Maintain laboratory equipment, including pumps, pH meters, and flow meters.
10. Keep department leadership informed of any issues that arise.
11. Monitor inventory levels of common laboratory supplies.
12. Fulfill additional job responsibilities as required.
13. Respond to emergency notifications.
14. Availability for flexible hours, including weekends.


Minimum Qualifications:
- High school diploma or equivalent; an Associate's degree is preferred along with a minimum of 2 years of laboratory experience.
- Basic laboratory skills and an understanding of safety protocols.
- Familiarity with Quality System Regulations is essential.
- Experience handling potentially hazardous chemicals and human source materials.
- Ability to routinely lift 25 lbs and occasionally lift up to 50 lbs.


Essential Hiring Criteria:
- Compliance with GMP, QSRs, ISO, and IVD regulations in all departmental duties.
- Proficiency in reading, writing, and comprehending English instructions, both written and verbal.
- Competence in basic arithmetic operations, including addition, subtraction, multiplication, and division across various units of measure.
- Familiarity with Microsoft Word, Excel, and Outlook.


Additional Skills:
No additional skills are listed.



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