8 days old

Quality Control Microbiology Sr. Specialist - IMMEDIATE NEED

Kelly Services
Arcadia, CA 91007
Kelly Science & Clinical is excited to be hiring a **_Quality Control Microbiology Sr. Specialist_** for a leading Cell and Gene Therapy Manufacturing company in Arcadia, CA! As the **_QC Micro Sr. Specialist_** , you will contribute your talents to a purposeful way that impacts the lives of patients around the world. You will play a key role in the day-to-day operations of the cGMP QC Microbiology laboratory. The **_QC Micro Sr. Specialist_** will lead method transfer and validation studies, commission new equipment, author and edit Quality system procedures, lead continuous improvement initiatives, and represent QC on project teams for clinical and commercial products

**Job Duties Include:**

+ Handle the transfer and validation of test methods in support of drug substance release and stability testing.

+ Author and revise test methods, validation protocols and reports, Quality system SOPs, and supporting documents.

+ Support equipment onboarding and validation lifecycle, including operation and maintenance procedures and software systems.

+ Lead change controls, investigations, CAPAs, and continuous improvement initiatives to successful completion.

+ Performs validation of microbiological assays and provides training related to product, equipment, environmental and utility monitoring to include Bioburden, Endotoxin, Growth Promotion, etc.

+ Read EM plates by counting microbial colonies. Fill out appropriate reports and forms contemporaneously. Assist to perform microbial identification like gram stains, gene sequencing. Track all data and complete in a timely manner. Perform all activities in compliance with cGMP regulations.


+ Bachelors degree in Microbiology, Molecular and Cell biology, Biology or related field required. In lieu of this requirement, work experience may be considered

+ 5 7 years of work experience in Quality Control Microbiology for a GMP/cGMP regulated facility.

+ A strong background in method development, qualification and validation is highly desired. A background in quality control testing related to Biopharmaceuticals is required.

+ Shown in-depth knowledge of Microbiological methods across a wide range of technologies.

+ Proven scientific and technical ability to design and implement method development and validation experiments; analyze and present data; author and review protocol and reports, in support of regulatory submissions.

+ Demonstrated deep knowledge and experience of cGMP and the regulatory requirements for pharmaceuticals.

**Schedule: M-F 8AM-5PM**

Apply today to start a conversation on Whats Next for your Career!

Please feel free to schedule an interview directly with Regan to learn more:

**Additional questions may also be e-mailed to**

**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

**Why Kelly** **** **Science & Clinical?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
Posted: 2022-09-23 Expires: 2022-10-24

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Quality Control Microbiology Sr. Specialist - IMMEDIATE NEED

Kelly Services
Arcadia, CA 91007

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