Officer Quality Assurance

The incumbent will play a key role in ensuring product quality, regulatory compliance, and operational excellence by driving Quality Management System (QMS) and In-Process Quality Assurance (IPQA) activities across manufacturing operations. This role offers an opportunity to contribute to a highly regulated IVD/Medical Devices environment, supporting continuous improvement initiatives while ensuring adherence to GMP, ISO 9001, ISO 13485, and quality standards.

• Graduate/Post-Graduate in Life Sciences, Biotechnology, Microbiology, Chemistry, Pharmacy, or a related discipline.

• 2 to 5 years of Quality Assurance experience, including at least 1 year in the IVD or Medical Devices industry.

• Sound knowledge of GMP, Good Documentation Practices (GDP), Change Controls, CAPA, Deviations, Non-Conformance Management, and Validation practices.

• Knowledge of ISO 9001, ISO 13485, regulatory requirements, and audit processes.

• Understanding of ELISA, Clinical Chemistry, Rapid Diagnostics, Hematology, and related manufacturing processes.

• Proficiency in MS Office and quality documentation management.

• Strong communication, problem-solving, time management, and stakeholder management skills.

• Execute IPQA activities across fabrication, dispensing, manufacturing, packaging, and dispatch operations to ensure consistent product quality and compliance.

• Review and maintain SOPs, batch records, calibration schedules, logbooks, and technical documentation.

• Drive quality improvements by identifying deviations, non-conformances, and process risks, while ensuring timely investigations and CAPA implementation.

• Support QMS activities including handling of market complaints, Change Controls, audits (internal & external), training initiatives, and compliance programs.

•  Ensure adherence to GMP, GDP, ISO standards, safety requirements, and records management practices.

• Collaborate effectively with cross-functional teams to strengthen quality culture and operational excellence.

• Contribute to the delivery of safe, compliant, and high-quality products through a proactive, detail-oriented, and continuous improvement mindset.

Disclaimer:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Avantor is proud to be an equal opportunity employer.

We are an Equal Employment/Affirmative Action employer and VEVRAA Federal Contractor. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law.

If you need a reasonable accommodation for any part of the employment process, please contact us by email at recruiting@avantorsciences.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

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