Position Responsibilities and Objectives

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.

Qualifications

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.

Additional Information

Schedule:

40 hours per week

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.