Quality Specialist Culture Media
Quality Specialist Culture Media
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Salary Not Disclosed
1 Vacancy
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 predetermined 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 lotspecific Certificates of Analysis
- Draft and review technical documents including internal documentation and customer facing documentation (Instructions for Use Safety Data Sheets etc..
- Document nonconformances deviations and CAPAs.
- Perform troubleshooting testing for nonconforming 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 nonconformances 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:
- Bachelors degree in microbiology Biology Biochemistry or a related field.
Minimum Qualifications:
- Handson 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 fulltime 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.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
