Quality Specialist

Horsham, PA, USA

Full-time

Company Description

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 is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. Eurofins is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. The Group also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 50 countries. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

Job Description

Gold Standard Diagnostics Horsham, Inc. (GSD Horsham), a biotechnology company and member of the Eurofins Group, maintains offices, laboratories, and production facilities worldwide. GSD Horsham is an international provider of rapid test kits supporting regulatory agencies, academic institutions, and industrial research organizations. Our core strengths include customer focus, responsive service, and consistently high-quality products.

GSD Horsham is seeking a Quality Technician to join our team in Horsham, PA.

Responsibilities include, but are not limited to:

• Complying with all aspects of the Quality Management System; GSD Horsham is ISO 9001 and ISO 13485 certified

• Performing routine QC testing on finished goods, intermediate products, and/or raw materials to verify conformance with predetermined product specifications outlined in approved production worksheets (PWS); conducting physical inventory counts as needed

• Maintain laboratory inventory of supplies and bacterial strains

• Exercising appropriate care and attention when handling hazardous materials

• Ensure calibration/verification of all laboratory equipment

• Reviewing production worksheets and material specifications for completeness, accuracy, and conformance

• Create and publish lot-specific Certificates of Analysis

• Drafting and reviewing technical documents, including internal documentation and customer-facing materials such as Instructions for Use and Safety Data Sheets

• Documenting nonconformances, deviations, and CAPAs

• Assisting with new product development, including formulation development, shelf-life and stability studies, and required testing associated with the change control process

• Planning and executing validations for equipment used in QC and manufacturing; collecting objective evidence of conformance and drafting final validation reports upon completion

• Initiating document changes within the QMS, as well as reviewing and approving changes initiated by others

• Performing Risk Management evaluations and reviewing and approving evaluations completed by others

Qualifications

The ideal candidate will possess:

• Strong computer and organizational skills

• Excellent oral and written communication skills, with strong attention to detail

• Ability to work independently and as part of a team

• Self-motivation, adaptability, and a positive attitude

• Ability to learn new techniques, manage multiple tasks simultaneously, maintain accurate records, follow instructions, and comply with company policies

• Bachelor’s degree in a science-related field

• Experience with and knowledge of ISO 13485:2016 and ISO 9001:2015

• 1-3 years of microbiology laboratory experience

• Experience with aseptic technique, media preparation and sterilization

Basic minimum requirements:

• Ability to stand for prolonged periods of time and lift up to 50 lbs.

• 0-3 years of laboratory experience

• Authorization to work in the United States indefinitely without restriction or sponsorship

Additional Information

This is a full-time, Monday through Friday position. Candidates who currently live within a commutable distance of Horsham, PA are encouraged to apply.

What we offer:

• 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 In Vitro Diagnostics Solutions is a Disabled and Veteran Equal Employment Opportunity employer.