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Quality Control Microbiology Jobs in USA
Quality Control Specialist: A Career in Microbiology and Pharmaceutical Quality Assurance
Are you passionate about ensuring the safety and efficacy of pharmaceutical products? Do you have a background in microbiology or related sciences? If so, you might be the perfect fit for a Quality Control Specialist position at Randstad Life Sciences US a major pharmaceutical company in Berkeley, CA.
Overview of the Job
As a Quality Control Specialist, your primary responsibility will be to perform microbiology assays and validation activities that support Good Manufacturing Practice (GMP), clinical trials, and the release of development products. You will work on the Inspire-01 project and play a crucial role in ensuring the safety and quality of pharmaceutical products.
Key Responsibilities
KEY SKILLS:
Endotoxin testing, Bioburden testing, Growth promotion, Environmental monitoring, QC – Microbiology
Description:
Quality Control Microbiology – Perform microbiology (sterility, LAL (Endotoxin), bioburden, identification, virology) assay and validation activities supporting GMP, Clinical, development product release.
POSITION SUMMARY-
This position is to support related QC Assay testing/validation for Inspire-01 project.
Here are some key responsibilities you can expect in this role:
- Method Validation: You will conduct microbiological method validation, including bioburden, sterility, LAL (endotoxin), and virology methods. This involves writing protocols and reports.
- Sample Testing: You will execute microbiological methods per approved protocols and test routine as well as investigational samples.
- Compendial Methods: Familiarity with compendial methods for specific commercial products and maintaining records of method qualification/validation.
- Investigation: Investigate questionable test results, write protocol deviation reports (PDR), and collaborate with Quality Assurance on method validation approaches.
- Stay Current: Keep up to date with revisions to compendial monographs and test methods, and update Standard Operating Procedures (SOPs) accordingly.
- Diverse Activities: You’ll need to support and prioritize various activities while meeting schedule commitments.
- Knowledge and Skills: Thorough knowledge of microbiological analytical methods, compendial requirements (USP, EP, JP), biologics, and manufacturing processes.
- Computer Skills: Strong computer skills, including proficiency in Word, Excel, Access, and PowerPoint, as well as experience with Laboratory Information Management Systems (LIMS) and SAP.
- Laboratory Experience: Prior experience in a Quality Control microbiology testing laboratory is highly beneficial.
- Independence: The ability to work independently with minimal supervision is essential.
Requirements
To be eligible for this position, you should meet the following requirements:
- Education: A minimum of a bachelor’s degree in microbiology or a related science field.
- Experience: 2+ years of experience in microbiological method validation in the pharmaceutical or related industry or an equivalent combination of education and experience.
Preferences
While not required, the following preferences are desirable:
- Demonstrable experience with cGMP and regulatory compliance (FDA, EMA, and other international agencies).
Compensation
The compensation for this role in Berkeley, CA, ranges from $30/hr to $35/hr, depending on your skills, experience, and location.
About the Company
This Quality Control Specialist position is offered by Randstad Life Sciences US, a leading pharmaceutical manufacturing company with a commitment to improving healthcare through innovative medicines. Randstad North America, Inc., their parent company, is a global HR services provider with a mission to support people in realizing their true potential throughout their working lives.
How to apply
If you are a microbiology enthusiast with a keen eye for detail and a passion for ensuring the quality and safety of pharmaceutical products, this Quality Control Specialist position is a perfect fit for you. Join the team at Randstad Life Sciences US and contribute to a world where diseases are not only treated but effectively prevented and cured. Make a significant impact on medical progress and help create a better world through science and innovation.
To apply for this exciting career opportunity, visit Randstad’s website and take the first step towards a rewarding career in pharmaceutical quality control. Your journey to a better world begins here!
Quality Control Microbiology Jobs in USA
Quality Control Microbiology Jobs in USA
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Quality Control Microbiology Jobs in USA
Quality Control Microbiology Jobs in USA
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