Onsite QA Specialist - IVD/ISO Compliance (San Diego)

Actalent; San Diego (CA); Sur place; USD 41 000 - 51 000; Plein temps

Avantages offerts par ce poste

Medical, dental, and vision insurance

401(k) retirement plan

Paid time off

Résumé du poste

Actalent in San Diego, CA seeks a Quality Assurance Specialist to provide quality oversight in an ISO-regulated manufacturing environment. The role centers on reviewing batch records and documentation to ensure accuracy, completeness, and compliance prior to product release.

Responsibilities include reviewing production records, material inspection records, calibration docs, supporting lot release, and preparing Certificates of Analysis as needed.

Qualifications

• Bachelor's degree in Life Sciences, Engineering, Business, or related field.
• 3+ years of QA experience in regulated manufacturing.
• Preferred knowledge of IVDR.

Responsabilités

• Review and approve quality system records including NCRs, CAPAs, complaints, deviations, and change orders.
• Support investigations, root cause analyses, risk assessments, and effectiveness checks.
• Maintain quality records and support internal and external audits.
• Participate in training activities and assist with various quality projects as business needs arise.
• Help maintain compliance with ISO:2016 standards and support quality system activities within a regulated IVD/CDMO environment.
• Perform detailed review of manufacturing records, production records, material inspections, calibration records, and support product release activities.

Connaissances

21 CFR 820

Documentation review

Regulatory interpretation

Problem solving

Communication skills

Computer systems

Formation

Bachelor's degree in Life Sciences, Engineering, Business, or related field

Description du poste

Actalent in San Diego, CA seeks a Quality Assurance Specialist to provide quality oversight in an ISO-regulated manufacturing environment. The role centers on reviewing batch records and documentation to ensure accuracy, completeness, and compliance prior to product release.

Responsibilities include reviewing production records, material inspection records, calibration docs, supporting lot release, and preparing Certificates of Analysis as needed.