Indianapolis 0 - 0 p/h Contract
Job Responsibilities
Lead and document investigations related to nonconformances, deviations, and atypical events; develop and implement appropriate corrective and preventive actions (CAPA).
Initiate, assess, and/or approve change control documentation impacting batch documentation, procedures, analytical methods, specifications, and related quality system records.
Utilize structured problem-solving methodologies (e.g., risk assessments, root cause analysis tools, failure mode evaluations) to support investigations and improvement projects.
Evaluate quantitative and qualitative data to identify trends, support event investigations, and contribute to operational efficiency and cost optimization efforts.
Support activities involving controlled or regulated materials in accordance with established safety and compliance standards.
Promote a culture of quality and safety by ensuring adherence to internal policies, procedures, and training requirements.
Maintain working knowledge of applicable U.S. and international regulatory expectations and industry standards.
Prepare and/or review periodic product quality reports and related compliance documentation.
Assist with regulatory inspections and internal audits by providing documentation, explanations, and subject matter support as needed.
Ensure ongoing compliance with applicable regulatory frameworks and quality system requirements.
Qualifications
Bachelor’s degree in a scientific discipline (Biology, Chemistry, or related field) preferred; equivalent industry experience may be considered in place of formal education.
3 years of experience in a regulated manufacturing or quality environment.
Demonstrated ability to investigate complex issues, make sound decisions, and manage priorities in a fast-paced setting.
Strong analytical capability, including data interpretation and basic to advanced mathematical calculations.
Proficiency with Microsoft Office applications and general computerized systems.
Effective written and verbal communication skills, including technical documentation experience.
Ability to work both independently and collaboratively across functional teams.
Reliable attendance and the ability to manage multiple assignments with a high level of accountability.
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