- Document Control: Oversee document control procedures, including document creation, review, approval, and distribution, ensuring accuracy, completeness, and compliance with regulatory standards.
- Batch Record Review: Review batch records, production documents, and associated records to ensure adherence to standard operating procedures (SOPs) and regulatory requirements.
- Quality Investigations: Lead and participate in investigations of deviations, out-of-specification (OOS) results, and non-conformances, employing root cause analysis techniques to identify corrective and preventive actions (CAPAs).
- Change Control Management: Manage change control processes, assessing proposed changes for potential quality impact, and ensuring appropriate documentation, evaluation, and approval in accordance with established procedures.
- Supplier Quality Management: Collaborate with procurement and supplier management teams to establish and maintain supplier quality agreements, conduct supplier audits, and ensure supplier compliance with quality requirements.
- Validation and Qualification: Participate in validation and qualification activities for equipment, processes, and systems, ensuring compliance with regulatory expectations and industry standards.
- Training and Development: Develop and deliver training programs on quality systems, procedures, and regulatory requirements to ensure awareness and competency among manufacturing personnel.
- Risk Management: Apply risk management principles to assess, mitigate, and control quality risks associated with manufacturing processes, products, and systems.
- Continuous Improvement: Identify opportunities for process optimization, quality enhancements, and efficiency improvements through data analysis, trend monitoring, and performance metrics.
- Regulatory Compliance: Stay abreast of evolving regulatory requirements, guidelines, and industry best practices to ensure ongoing compliance and readiness for regulatory inspections.
- Audit Support: Support internal and external quality audits, regulatory inspections, and customer audits by providing documentation, conducting walkthroughs, and addressing audit findings in a timely manner.
- Bachelor's degree in pharmaceutical sciences, chemistry, chemical engineering, or a related field. Advanced degree preferred.
- Proven experience in quality assurance roles within the pharmaceutical or biotechnology industry, with a strong understanding of cGMP regulations and quality management principles.
- Excellent analytical, problem-solving, and decision-making skills, with the ability to effectively prioritize and manage multiple tasks in a fast-paced environment.
- Strong communication and interpersonal skills, with the ability to collaborate cross-functionally and influence stakeholders at all levels of the organization.
- Certification in quality management (e.g., ASQ Certified Quality Engineer) or relevant professional certifications (e.g., Six Sigma, Lean Manufacturing) is a plus.
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Quality Engineer - Indianapolis, United States - Harba Solutions Inc.
Description
Job Responsibilities:
Qualifications:
???? Contact your Recruiter:
For more information about the role and to express your interest, you can reach out to our recruiter, Lauren Keltz, directly:
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???? About Harba Solutions:
Harba Solutions is a leading scientific services firm operating across a range of scientific industries including pharmaceuticals, biotechnology, medical devices, contract research organizations, and agricultural sciences. With a substantial network of qualified scientific candidates and ongoing interactions with emerging talents, we specialize in effectively placing scientific professionals in roles encompassing laboratories, chemistry, biology, and quality-focused disciplines, to name a few. Backed by strategic investors, our core values of commitment, work ethic, team and self-ownership, craft mastery, and pursuit of success shape our mission. Explore the opportunities at Harba Solutions and become part of the evolution of scientific services.
