Quality Specialist

Eurofins USA In Vitro Diagnostics Solutions•Horsham, PA

11d•Onsite

About The Position

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. 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. The Group has grown from one laboratory in Nantes, France to 55,000 staff across a decentralized 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.

Requirements

Bachelor’s degree in microbiology or related field. Extensive experience can be substituted for degree.
Experience with and knowledge of ISO 13485:2016 and ISO 9001:2015
1-3 years of microbiology laboratory experience
Able to work independently, exercise good judgement, and prioritize tasks and workload.

Responsibilities

Perform routine QC testing as required on finished goods, intermediate products and/or raw materials to demonstrate agreement with pre-determined product specifications outline in approved production worksheets (PWS).
Maintain laboratory inventory of supplies and bacterial strains.
Ensure calibration/verification of all laboratory equipment.
Review production worksheets and material specifications for completion, accuracy, and conformance.
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.
Assist with new product development, including formulation development and shelf life/stability studies.
Perform any testing required as part of change control process.
Plan and execute validations on equipment used in QC and in manufacturing.
Collect objective evidence of conformance and draft 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.
Manage documents and Quality records.
Initiate non-conformances, planned deviations, CAPAs, etc., as well as review and approve records initiated by others.
Perform Risk Management evaluations, as well as review and approve Risk Management evaluations performed by others.
Initiate and lead Change Control processes, as well as review and approve Change Controls initiated by others.
Assist the Quality Manager with the approval of suppliers.
Assist and participate in Quality Planning and Management Reviews.
Assist the Quality Manager in the process of internal and external audits.
Additional tasks performed where appropriate.