QC Microbiology Aseptic EM Specialist

Job Introduction

Thanks for checking out our vacancy, we're delighted you want to learn more about Dechra.

Dechra is a growing, global specialist within the world of veterinary pharmaceuticals. Our expertise is in the development, manufacture, marketing and sales of high quality products exclusively for veterinarians worldwide.

Here at Dechra, our values are embedded within our culture and thrive within our family of almost 2000 colleagues globally. From manufacturing to marketing, (D)edication, (E)njoyment, (C)ourage, (H)onesty, (R)elationships and (A)mbition are at the heart of our everyday operations and the way we do business

The Opportunity

The QC Microbiology Aseptic Environmental Monitoring Specialist will support the Environmental Monitoring Program and QC Microbiology department in the GMP Quality organization. The Aseptic EM Specialist will ensure that all aspects of environmental sampling and testing associated with utilities and classified areas are within established alert and action levels. In addition, the specialist will support the organization by performing microbiological testing required for the release of raw materials, products and water for injection

Role Responsibility

So, what will you be doing? This role has a broad and varied remit and the successful candidate will have responsibility for duties including:

• Perform routine Environmental Monitoring (EM) of surface, viable air, non-viable particulates and settling plates in ISO 5, ISO 7, and ISO 8 classified areas.

• Participate in media fills and product fills which includes continuous monitoring of air quality, personnel, and environment integrity.

• Sample and Read Environmental Monitoring plates and assess the results per specifications as appropriate.

• Review raw data and enter results in Laboratory Information Management System (LIMS).

• Incubate and enumerate organisms on cultured media.

• Perform compressed gas sampling and testing.

• Perform microbial isolation techniques, gram stains, and microbial identification.

• Perform sampling and bioburden testing for Water for Injection (WFI).

• Perform LAL testing of WFI, Raw Materials and Finished Products.

• Perform Sterility Testing for Product release and Stability samples.

• Documentation in accordance with current Good Manufacturing Practices (cGMP)

• Coordinate with manufacturing to schedule sampling of WFI, EM, and personnel.

• Support of process validation and equipment qualifications.

• Responsible performing growth promotion testing of Microbiological media.

• Ability to aseptically gown and work in a sterile work environment.

• Flexibility in following work schedule requirements that may include off-hour and weekend work.

• Ability to read, understand and follow SOPs.

• Monitoring temperatures of incubators and refrigerators.

• Track and trend EM data including Microbial identification results in support of product release.

• Provide input on SOP revisions and may assist in the creation and editing of protocols and procedures.

• Participate in and aid in the writing of Deviation, OOS, CAPA's and alert investigations.

• Order laboratory supplies as needed.

• May perform other general laboratory duties as assigned.

The Ideal Candidate

Here at Dechra we pride ourselves on being an inclusive employer and we embrace candidates from all walks of life. We're particularly keen to hear from those who have/are:

• Aseptic pharmaceutical experience

• ISO 5 Aseptic Gowning

• Media Fill experience

• Endotoxin testing (Product & Water)

• Sterility testing

• Investigation writing (OOS/Deviations)

• Environmental Monitoring Experience (Viable air monitoring, Particulate monitoring, surface sampling)

• Water Testing (Bioburden/HPC, TOC, Conductivity)

• GMP/GDP experience

• Must not be allergic to Cephalosporin

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About the Company

As a people first values-based culture, we provide free weekly wellness sessions focused on our employee's physical and mental wellbeing, and flexible work arrangements. We offer a generous employer 401k match and competitive salary packages for financial wellness. Our full array of health, financial and voluntary benefit programs are what you would expect from a recognized Best Place to Work.

Dechra Pharmaceuticals PLC

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