Freshers Biology QA Job at Beckman Coulter Life Sciences

Essential Duties and Responsibilities –

• Maintain and monitor quality management system and protocols including processes, and procedures that ensure compliance with regulations and standards.
• Responsible for final product release based on verification of compliance to all Quality System and Regulatory requirements.
• Responsible for performing In-Process Quality Assurance activities as per applicable procedures.
• Responsible for handling product related non-conformances and other deviations within the site.
• Support audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors throughout all stages of the audits.
• Reports status of activities to supervisor and is responsible for communicating Quality and Regulatory related issues or opportunities to the next management level.
• Performs other related duties as required.

Qualification and Experience –

Minimum Requirements –

• Bachelors or master’s degree in biology, Engineering or related disciplines
• Minimum of 0-3 years related experience in quality assurance and/or regulatory affairs
• Knowledge of ISO 13485, GMP and GLP requirements would be advantageous
• Experience with handling product batch releases and non-conforming products.

Required Competencies –

• Exceptional communication skills (verbal/written/presentation/relationship building) with the ability to work collaboratively with cross-functional project teams and regulators
• Ability to drive results, foster teamwork, handle pressure, and provide feedback.
• Must be able to demonstrate skills in root cause investigation and problem-solving.
• Organized, detail-oriented with impeccable integrity.
• High level of initiative, self-motivation, and energy.