Quality Specialist

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 :

• Bachelors 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.

Remote Work :

No

Employment Type :

Full-time