Quality Specialist, Culture Media

Eurofins Scientific is an international life sciences company, which provides a unique range of analytical testing services to clients across multiple industries. The Group believes it is the world leader in food, environment, 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 for supporting clinical studies. In addition, Eurofins is one of the leading global emerging players in specialty clinical diagnostic testing.

In 2018, Eurofins generated 4.2 billion Euro proforma turnover in 800 laboratories across 47 countries, employing about 45.000 staff.

Eurofins stands for a conception of clinical diagnostics entirely focused on excellence, innovation and technological investment. Eurofins clinical diagnostics offers testing services in all medical specialties. 

As a central element in healthcare, clinical diagnostics contributes to every stage of patient care: predisposition, prevention, diagnostics, treatment monitoring and prognosis. 

With hundreds of thousands of clinical diagnostics tests performed every day, the laboratories of the clinical diagnostics division strive to ensure that every patient, wherever he or she lives, has access to the most specialized and most innovative techniques for diagnosis, monitoring and therapeutic adjustment. Our logistics expertise and our daily sample collection and delivery network, guarantee perfect continuity in the provision of care while ensuring the same standard of quality and access to innovation across all the regions we serve.

Gold Standard Diagnostics Horsham LLC, a Eurofins Technologies company, develops, manufactures, and commercializes tests kits and microbiological media for the global food safety and environmental markets.  We are constantly collaborating with government, industry, and academic leaders worldwide to develop innovative methods and applications.

The Quality Specialist will be responsible for supporting our Quality Assurance and Quality Control operations. The successful candidate will ensure that our culture media products meet rigorous regulatory, safety, and quality standards, and will play a vital role in maintaining compliance with GMP/ISO standards.

Quality Specialist, Culture Media Responsibilities include, but are not limited to, the Following:

• Perform and document routine QC testing as required on finished goods, intermediate products, and/or raw materials in order to demonstrate agreement with pre-determined product specifications outlined in approved production worksheets
• Review production worksheets and material specifications for completion, accuracy, and conformance.
• Maintain laboratory inventory of supplies and bacterial strains.
• Ensure calibration/verification of all laboratory equipment
• Create and publish lot-specific Certificates of Analysis
• Draft and review technical documents, including internal documentation and customer facing documentation (Instructions for Use, Safety Data Sheets, etc.).
• Document non-conformances, deviations, and CAPAs.
• Perform troubleshooting testing for non-conforming product.
• Plan and execute validations on equipment used in QC and in manufacturing. Collect objective evidence of conformance and draft a final validation report after validations have concluded
• Initiate the change of documents within the QMS, as well as review and approve changes initiated by others.
• Initiate non-conformances, planned deviations, CAPAs, etc., as well as review and approve records initiated by others.
• Assist with new product development, including formulation development and shelf life/stability studies. Perform any testing required as part of change control process.

Minimum Educational Qualifications:

• Bachelor’s degree in microbiology, Biology, Biochemistry, or a related field.

Minimum Qualifications:

• Hands-on experience with microbiological testing methods and culture media quality control.
• Previous experience in manufacturing or quality control setting.
• Knowledge of ISO 9001 and ISO 13485, and relevant regulatory standards.
• Experience with laboratory techniques, including aseptic, media preparation, sterilization, microbiological culture techniques, and analytical methods.
• Authorization to work in the United States indefinitely without restriction or sponsorship

The Ideal Candidate Possesses the Following:

• Strong attention to detail and documentation skills

Position is full-time working Monday - Friday 8:00am - 4:30pm with overtime as needed.  Candidates currently living within a commutable distance of Horsham, PA are encouraged to apply.

• 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

Eurofins USA Clinical Diagnostics is a Disabled and Veteran Equal Employment Opportunity employer.