We are seeking a highly detail-oriented and analytical Quality Control (QC) Specialist to ensure our products, services, and processes within the healthcare environment meet the highest quality and regulatory standards. This role plays a critical part in ensuring compliance, patient safety, and service excellence.

Job Description

• Perform routine inspections, sampling, and testing of materials, products, and services in compliance with internal protocols and regulatory requirements (e.g., ISO, FDA, BPOM, or healthcare accreditation standards).
   
• Monitor and assess the performance of laboratory/clinical procedures or production processes to ensure consistency and adherence to defined standards.
   
• Maintain accurate records of quality inspections, non-conformances, deviations, and corrective/preventive actions (CAPA).
   
• Collaborate with cross-functional teams (e.g., Production, R&D, Compliance, Laboratory, Clinical) to address quality issues and implement improvements.
  Conduct audits (internal and supplier) and support external inspections or regulatory audits.
   
• Review and update Standard Operating Procedures (SOPs), quality documents, and validation protocols.
   
• Assist in training staff on quality standards, regulatory updates, and best practices.
  Analyze data trends and generate quality reports to support decision-making.

Requirements

• Bachelor’s degree in Pharmacy, Biology, Chemistry, Medical Technology, Engineering, or a related field.
  Minimum [2-5] years of experience in quality control, preferably within the healthcare, pharmaceutical, clinical, or medical device industry.
   
• Familiarity with regulatory standards such as ISO 13485, ISO 9001, GMP, GLP, GCP, or CAP.
   
• Strong knowledge of quality management systems, risk assessment, and process validation.
   
• Excellent attention to detail, documentation skills, and problem-solving abilities.
   
• Proficient in MS Office Suite; experience with LIMS, QMS, or audit management software is a plus.
   
• Strong interpersonal and communication skills.