QC Microbiologist - Senior Associate--Eurofins - Eurofins PSS Insourcing Solutions, LLC

The work we do at Eurofins matters, and so do our employees. At Eurofins, we put a focus on your professional growth. We provide our employees the ability to break into the biopharmaceutical industry and grow from the bottom up. We have the supportive teams and tools available to invest in you while also affording you work-life balance and a competitive benefits package.

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.

If you’re looking for a rewarding career, a place to call home, apply with us today!  

ROLE SUMMARY:

The Quality Control Microbiology department is seeking a highly motivated candidate to support GMP microbial testing at the Sanford North site.  The work includes testing of various microbial assays such as Environmental Monitoring (EM), Utility Monitoring (UM), Gas Testing, Sterility Testing, Bioburden testing, Endotoxin Testing, Growth Promotion, Micro ID, Data Review and other assays as needed for in-process, release, stability, etc. Focus areas to also include execution of analytical method qualification/validation protocols.

The candidate will be expected to support the Microbiology Laboratory such as authoring procedures, documents, stocking materials, inventory and other activities as necessary. 

The successful candidate will be team oriented, have a “right the first time” attitude, detailed oriented, exhibit equity and inclusiveness and take initiative to learn and develop in the role to support the Microbiology Laboratory.

ROLE RESPONSIBILITIES:

• Perform routine and non-routine environmental monitoring (total particulates, air viable and surface viables), utility monitoring and gas testing of GMP manufacturing clean rooms and lab areas
• Initiate and participate in EM excursion investigations and assess any potential impact on product quality
• Assist in trending and EM data and generate quarterly and yearly reports
• Perform bioburden, endotoxin, sterility testing, Micro ID, TOC and Conductivity
• Author standard operating procedures, assay qualifications and other GMP documents as necessary
• Aid as necessary to maintain the function of the QC lab to include ordering materials, inventory, general housekeeping and other duties as necessary
• Operate in high regard, integrity and efficiency to generate accurate and quality results with a customer focused mind-set
• Utilize laboratory instruments and equipment in accordance to established procedures to include but not limited to air samplers, particle counters, endotoxin readers, microscopes, etc.
• Perform instrument performance qualifications
• Perform assay qualifications for in-process, drug substance, buffers, etc. and author reports
• Perform analysis and data analysis of in-process, APIs, and stability samples using existing methods
• Train and mentor other associates on lab assays
• Author and review Quality Control SOPs
• Maintain QC lab and provide assistance as needed during equipment and facility activities
• Interact closely with other departments to ensure efficient, compliant and timely execution of product activities
• Assist in investigation and review of GMP quality events to include deviations, out of specification reports and audit findings
• Act as a QC Microbiology SME (Subject Matter Expert) during internal/external audits, risk assessments, and investigations
• Operate under minimum supervisor and support special projects as needed
• Support continuous improvement projects related to QC
• Ability to author environmental monitoring excursion reports, deviations, CAPA and SOPs as needed
• Demonstrated understanding of USP, EP and FDA microbiological testing requirements
• Support Microbiological staff members as needed

BASIC MINIMUM QUALIFICATIONS:

• Be able to communicate effectively with colleagues and supervisors.
• Good decision making based on procedures, experience and guidance.
• Ability to gown for and work in a cleanroom environment
• Minimum B.S. degree of a relevant discipline such as microbiology, bioengineering, chemistry, biological sciences, etc.
• ≥ 8 years of experience environmental monitoring in a GMP environment.
• ≥ 8 years of experience in a GMP microbiology laboratory.
• ≥ 8 years of experience on assays such as bioburden, endotoxin, TOC, conductivity, plate reading, gram staining, Micro ID, sterility.
• Experience and knowledge of GMP, following standard test methods.
• Knowledge of Microsoft Office applications e.g. Word, Excel, Power Point, MS Visio, etc.

PREFERRED QUALIFICATIONS:

• In depth understanding and experience of Microbiology testing
• Technical Writing
• Project Management
• Experience with LIMS (nice to have specifically MODA)
• Deviation and alert/action excursion write-ups
• Experience with instrument validations
• Able to troubleshoot instrumentation
• Able to recognize OOS results and participate in excursion investigations

Position is Full Time, Multiple Shifts Available. Candidates currently living within a commutable distance of  Sanford, NC are encouraged to apply. Excellent full-time benefits including comprehensive medical coverage, dental, and vision options.

• Excellent full-time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays
• Eligibility for potential yearly Bonus & Merit-Based Pay Increases

Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.