Onsite Specialist II, Scientific Support

The Non-Conformance Investigator is responsible for leading and documenting investigations related to quality incidents and other non-conformances within the Quality Control department. The role focuses on identifying root causes, assessing product and compliance risks, and implementing effective corrective and preventive actions (CAPAs) to prevent recurrence. The investigator collaborates closely with QC analysts, QA, manufacturing, and other stakeholders to ensure timely closure of investigations and compliance with GMP regulations.

• →Investigate QC deviations, OOS/OOT results, and non-conformance events.
• →Perform root cause analyses using tools such as Fishbone, 5 Whys, and trend analysis.
• →Assess the impact of quality events on products, processes, and compliance.
• →Develop and track CAPAs to completion.
• →Prepare clear and accurate investigation reports.
• →Support regulatory inspections and internal audits.
• →Identify recurring issues and recommend process improvements.
• →Ensure investigations are completed within defined timelines and quality standards.

• Degree in Life Sciences, Chemistry, Pharmacy, or a related field.
• Experience in a GMP-regulated pharmaceutical or biotechnology environment.
• Knowledge of deviation management, CAPA, OOS investigations, and quality systems.
• Strong analytical, problem-solving, and technical writing skills.

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.

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