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Quality Control Associate
2 weeks ago
We are hiring for our rapidly growing client in the biotech IVD manufacturing business, based in Bengaluru.
Job Title: QC Associate
Location: Bengaluru
Education and Experience:
- MSc in Biotechnology/ Molecular Biology.
- 3-4 years of industrial experience in Quality Control.
Desirable:
- Expertise in QC for molecular diagnostic product manufacturing or development.
- ISO 13485 Internal Auditor Certificate.
- Experience in risk management, Statistical Process Control (SPC), and Six Sigma methodologies.
Work Profile:
The QC Associate will manage daily operations in the Quality Control (QC) department for In Vitro Diagnostics (IVD) products. This role ensures that products meet the required quality standards through testing, inspections, and compliance with regulatory guidelines (ISO 13485). Collaboration with cross-functional teams (R&D, Manufacturing, Regulatory Affairs) is essential to maintain compliance and ensure product safety and efficacy.
Key Responsibilities:
Quality Control and Testing:
- Conduct and supervise routine and non-routine testing of raw materials, in-process materials, and finished products.
- Perform analytical and functional testing and validation of IVD products according to specifications and regulatory standards.
- Oversee environmental monitoring and sterility testing for controlled environments used in manufacturing.
- Maintain and calibrate laboratory equipment, ensuring compliance with calibration standards.
Documentation and Reporting:
- Ensure timely documentation of QC results in compliance with Good Documentation Practices (GDP).
- Review and approve laboratory test results, identifying deviations or out-of-specification (OOS) results.
- Maintain QC records, batch release documentation, and Certificates of Analysis (CoA).
- Assist in the creation and revision of Standard Operating Procedures (SOPs) related to QC processes.
Compliance and Regulatory:
- Ensure compliance with ISO 13485 and other relevant standards for medical devices and IVD products.
- Participate in internal and external audits, ensuring adherence to regulatory and company-specific requirements.
- Manage product recalls and non-conformances, performing root cause analysis and implementing CAPA.
Team Leadership and Training:
- Provide leadership and guidance to junior QC staff, including mentoring and performance evaluation.
- Conduct training for QC personnel on new testing methods, equipment, and procedures.
- Assist the QC Manager in workload distribution and planning to meet production deadlines.
Continuous Improvement:
- Lead initiatives for continuous improvement in QC processes and product quality.
- Collaborate with cross-functional teams to optimize production processes and reduce quality risks.
- Identify and implement improvements in testing methods, QC protocols, and laboratory operations.
Skills and Competencies:
- Strong understanding of QC principles, laboratory testing methods, and regulatory compliance in the IVD field.
- Proficiency with laboratory instruments (e.g., spectrophotometers, PCR machines).
- Excellent analytical and problem-solving skills.
- Strong organizational skills and ability to manage multiple tasks.
- Good communication and interpersonal skills for cross-functional collaboration.
- Proficiency in quality management software and Microsoft Office Suite.
Working Conditions:
- Primarily laboratory-based, with some office work for documentation.
