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16 days old

Quality Control Microbiology Associate

Kelly Services
Carlsbad, CA 92008
For over 25 years Kelly Science & Clinical has been connecting scientific professionals with industry leading employers. Today we are excited to be hiring a **_Quality Control Microbiology Associate_** for a leading pharmaceutical manufacturing company in Carlsbad, CA. The **_QC Micro Associate_** will provide support in the microbiology program, to include aseptic fill/finish activities, environmental monitoring, gowning qualification, and analysis of compendial microbiology assays that include endotoxin, bioburden, and sterility. The **_QC Micro Associate_** will also be responsible for ensuring all activities are performed within an appropriate level of cGMP compliance.


**Responsibilities:**


+ Serve as a subject matter expert (SME) for Microbiological assays and methods during internal/external audits, risk assessments, investigations, and client visits

+ Supports assay transfer, qualification, and validation activities for microbial based assays or clients specific methods

+ Author, revise, and review Quality Control (QC) standard operating procedures (SOPs) and assay qualification protocols and reports

+ Perform analysis on in-process samples, APIs, raw materials, and stability samples using existing methods

+ Perform routine and non-routine environmental monitoring (EM) of GMP and GLP manufacturing facilities for total particulates, air viables, and surface viables.

+ Initiate and participate in the investigation of environmental monitoring excursions and assesses potential impact on product quality

+ Support a Gowning Qualification Program for all manufacturing and QC personnel

+ Perform Bioburden, Growth Promotion, Endotoxin, Gram Stain, Microscopy, TOC, Conductivity, and Nitrates testing

+ Maintain QC lab equipment and provide assistance, as needed, during equipment and facility qualification activities

+ Assist in trending EM data and generate quarterly and yearly reports

+ Assist in investigation and review of GMP quality events, including but no limited to deviations, non-conformances, and audit findings

+ Participate in inspection readiness activities


**Requirements:**


+ Combination of Undergraduate courses and on-the-job experience in Microbiology or a related discipline (e.g., biology, chemistry, or biological sciences).

+ Minimum five (5) years' experience in Quality Control and environmental monitoring of GMP facilities

+ Knowledge in environmental excursion investigations, root cause analysis, out of specifications, and knowledge of cleanroom practices is preferred

+ Direct experience with endotoxin, bioburden, and growth promotion methodologies. Experience in sterility testing is highly desired

+ Experience with transfers and qualification/validations of large molecule focused analytical methods


**_Interested Candidates:_**


**Apply for Immediate Consideration**


**Schedule and interview with Athena** https://calendly.com/athp320/interview


**Text Start to Athena at 714-868-5477 with any questions. Please be sure to include which job you are interested in**


**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.

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Posted: 2022-09-12 Expires: 2022-10-29

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Quality Control Microbiology Associate

Kelly Services
Carlsbad, CA 92008

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