Job Description

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.

Qualifications

_ 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

Additional Information

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.