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Urgent! QA Sterility Assurance Specialist (12 hrs rotating shift) Job Opening In Singapore, Singapore – Now Hiring ThermoFisher Scientific
**Work Schedule**
12 hr shift/days
**Environmental Conditions**
Able to lift 40 lbs.
without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc...
allowed, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
**Job Description**
**Environmental Conditions**
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
**Job Description**
**Position Summary**
This is an outstanding opportunity to join our team as a QA Sterility Assurance Specialist, where your expertise will ensure the flawless production of injectable sterile pharmaceuticals.
You will strictly adhere to cGMP norms and regulatory procedures, playing a meaningful role in our Global Sterility Assurance Group.
As a Subject Matter Expert, you will provide mentorship and ensure our site’s contamination control strategy is successfully implemented.
**Responsibilities**
+ Guarantee that safety remains our top priority and is lived throughout the organization.
+ Develop and maintain the Contamination Control Strategy (CCS) for the site, ensuring compliance with regulations.
+ Coordinate maintenance activities within the sterility assurance department to minimize environmental contamination and product risk.
+ Collaborate with the investigation team to manage quality events impacting sterility and evaluate deviations and complaints.
+ Review and approve major deviations and corrective/preventive actions related to sterility assurance.
+ Contribute to the development and revision of SOPs impacting sterility assurance and evaluate necessary changes.
+ Analyze data from Environmental Monitoring (EM) to identify trends and establish corrective measures.
+ Work with other teams to improve processes and systems, growing the Sterility Assurance Level (SAL).
+ Review and implement surveillance plans for aseptic techniques, ensuring any gaps are addressed.
+ Support engineering projects, particularly in the design phase, to ensure sterility assurance.
+ Prepare and revise risk assessments in compliance with Annex 1.
**Minimum** **Requirements/Qualifications**
**Education:**
+ Bachelor’s Degree in Microbiology, Biotechnology, Biochemical Engineering, or a related Pharma Scientific Area with equivalent experience considered
**Experience:**
+ 1 to 2 years of experience in a Quality department within a sterile production manufacturing site
**Proficiencies:**
+ Knowledge of cGMP environments
+ Technical expertise in microbiology, Endotoxin, Bioburden, Sterility, and associated testing protocols
+ Compliance with local, state, and federal regulations (e.g., NMPA, HSA, FDA)
+ Effective communication skills across all organizational levels
+ Ability to work cross-functionally with Quality Control, Operations, and Biologics teams
+ Participation in Health Agency/internal audits
**Technical skills:**
+ Strong background in sterility assurance, aseptic techniques, manufacturing of sterile injectables and Contamination Control Strategy (CCS).
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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Unlock Your QA Sterility Potential: Insight & Career Growth Guide
Real-time QA Sterility Jobs Trends in Singapore, Singapore (Graphical Representation)
Explore profound insights with Expertini's real-time, in-depth analysis, showcased through the graph below. This graph displays the job market trends for QA Sterility in Singapore, Singapore using a bar chart to represent the number of jobs available and a trend line to illustrate the trend over time. Specifically, the graph shows 831 jobs in Singapore and 646 jobs in Singapore. This comprehensive analysis highlights market share and opportunities for professionals in QA Sterility roles. These dynamic trends provide a better understanding of the job market landscape in these regions.
Great news! ThermoFisher Scientific is currently hiring and seeking a QA Sterility Assurance Specialist (12 hrs rotating shift) to join their team. Feel free to download the job details.
Wait no longer! Are you also interested in exploring similar jobs? Search now: QA Sterility Assurance Specialist (12 hrs rotating shift) Jobs Singapore.
An organization's rules and standards set how people should be treated in the office and how different situations should be handled. The work culture at ThermoFisher Scientific adheres to the cultural norms as outlined by Expertini.
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