QA specialist

Responsibilities:

• Responsible for ensuring the integrity of all data and documentation reported from the laboratory – routine reports, method verifications, validations, equipment qualifications, etc.
• Reviews all source data and associated documentation for accuracy and cGMP conformance
• Supports in the preparation and collation of training material and other relevant quality related activities
• Ensure compliance of the vendor qualification process
• Assist in the investigation and review of deviations, change controls, CAPAs, and OOS reports to assure complete compliant source data
• Perform internal audits and assist with client audits
• Supporting the team to ensure calibrations, facilities / equipment qualifications and verifications, and materials receipt are being managed and are up to date.
• Understands testing and procedures within quality testing
• Verify laboratory testing is conducted in accordance with SOPs as well as compendial (USP/NF, EU) and ISO 17025:2017 regulations
• Other duties as required and appropriate to support the quality function

Skills / Qualifications:

• Bachelor’s degree in the sciences Experience in an FDA regulated laboratory environment
• Proficiency in Microsoft Office
• Quality experience in a relevant industry sector/relevant quality standard(s)
• Excellent written and verbal communications skills
• Ability to solve complex
• Quality and technical related problems
• Experience in supplier management a plus
• Experience in cell biology and molecular biology laboratory techniques a plus
• Experience with eQMS a plus

Salary: $85k to $130k