AH-2511-401
QC TECHNICIAN MICROBIOLOGY
ASTURIAS

About the Role

We are looking for a highly skilled and detail-oriented QC Technician - Microbiology to join an important healthcare company. In this role, you will lead and oversee critical laboratory operations, ensuring compliance with GMP standards and regulatory requirements. You will play a key part in maintaining the integrity of the quality systems, driving process automation, and supporting continuous improvement initiatives.

Key Responsibilities

• Ensure compliance with company procedures on Safety, Environment, and Quality.
• Supervise and guide analysts in performing laboratory tests and activities.
• Review and approve analytical documentation, including test results, certificates of analysis, stability studies, and supplier qualifications.
• Collaborate in drafting SOPs, specifications, analytical methods, and stability protocols.
• Manage SAP entries for results, batch management, and material creation.
• Guarantee proper packaging and custody of QC samples (stability, cleaning, reference standards).
• Oversee calibration and qualification of laboratory instruments and maintain related documentation.
• Lead technical services activities: equipment calibration, qualification, and lifecycle management.
• Maintain updated procedures for computerized systems validation and ensure data integrity.
• Manage supplier qualification for services and equipment.
• Evaluate and review data from external laboratories.
• Drive continuous improvement projects and promote process optimization and automation.
• Support production and analytical development activities (method validations, transfers, investigations).
• Collaborate in aseptic process simulation design and execution.
• Provide technical support during audits and inspections by health authorities.
• Assist in preparing responses to technical inquiries from clients and regulatory bodies.
• Contribute to internal training and analyst qualification programs.

Regulatory & Quality Compliance

• Update laboratory procedures to meet GMP and pharmacopeia requirements.
• Review validation protocols and reports to ensure regulatory compliance.
• Participate in risk assessments, deviation investigations, and CAPA implementation.

What They Offer

• A dynamic and collaborative work environment.
• Opportunities for professional growth and involvement in innovation and automation projects.
• Exposure to international standards and interaction with health authorities and global suppliers.
• Competitive compensation and benefits package.

Qualifications

• Degree in Biology or related field.
• Valuable Microbiology specialization.
• Minimum 1 year of experience in Quality Control within the pharmaceutical industry working specialized in Microbiology.
• Excellent communication, and problem-solving skills.

Detalles / Details