Microbiology Quality Analyst – Bioburden & Sterility

Applied Medical; Rancho Santa Margarita (CA); Sur place; USD 73 000 - 75 000; Plein temps

Avantages offerts par ce poste

Competitive compensation and benefits

Education reimbursement program

401(k) with match

Paid holidays and vacation

Résumé du poste

Applied Medical is seeking a Microbiology Analyst to support bioburden, sterility, and other biological testing programs for medical device manufacturing. You will maintain lab records, review data, and ensure compliance with regulatory requirements within the Biological Sciences function.

The role involves coordinating with external laboratories, preparing protocols, and supporting cross-functional teams on testing activities, audits, and continuous improvement initiatives.

Qualifications

• Bachelor's degree in biological sciences or related field.
• 2–3 years of relevant professional experience in medical devices, life sciences, or regulated manufacturing environments.
• Experience supporting biological testing, quality, regulatory, or laboratory operations functions.

Responsabilités

• Coordinate Bioburden, sterility, and other testing programs with external labs and related purchasing processes.
• Monitor laboratory audits (quarterly/biannual) for compliance.
• Prepare and maintain testing protocols, study plans, and final lab reports per quality and regulatory requirements.
• Maintain lab data, identify trends, deviations, and investigation needs.
• Collaborate with Engineering, Manufacturing, Quality, and cross-functional teams to handle test samples.

Connaissances

Analytical thinking

Problem-solving

Attention to detail

Communication skills

Team collaboration

Project management

Adaptability

Formation

Bachelor's degree in biological sciences or related field

Outils

SOPs

Description du poste

Applied Medical is seeking a Microbiology Analyst to support bioburden, sterility, and other biological testing programs for medical device manufacturing. You will maintain lab records, review data, and ensure compliance with regulatory requirements within the Biological Sciences function.

The role involves coordinating with external laboratories, preparing protocols, and supporting cross-functional teams on testing activities, audits, and continuous improvement initiatives.