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Senior Quality Assurance Engineer
2 months ago
Position Title – Senior Quality Assurance Engineer
Location – Remote
Contract Duration – Long-term engagement
Working Hours – Standard business hours
Overview:
As a Senior Quality Assurance Engineer, you will play a crucial role in supporting a life sciences manufacturing environment, serving as a key expert in Quality Engineering. Your contributions will be vital in performing thorough root cause analyses (RCAs) and executing corrective and preventive actions (CAPAs) to ensure effective resolution of issues. You will also provide quality oversight to enhance Critical to Quality (CTQ) metrics, thereby fostering overall site enhancement initiatives.
Key Responsibilities:
- Analyze process and product discrepancies and out-of-specification conditions by utilizing various root cause analysis techniques, including Cause and Effect Diagrams and 5-Whys.
- Ensure compliance with regulatory standards and act as a coordinator for compliance-related activities.
- Address customer concerns with professionalism and efficiency.
- Diagnose issues related to electrodes and buffer solutions.
- Implement CAPAs to avert recurrence of deviations and nonconformities, and validate the effectiveness of these changes using appropriate quality tools.
- Guide the handling of non-conforming materials, including both final products and raw materials.
- Conduct statistical analyses to monitor and improve process and product performance, responding proactively to adverse trends.
- Lead change control processes for complex improvement initiatives using risk-based methodologies.
- Possess expert-level knowledge of Quality tools such as FMEA, risk analysis, validation principles, sampling plans, Six Sigma, and control plans.
- Participate in generating risk assessments for both products and processes.
- Demonstrate a strong understanding of validation principles, including the creation of protocols and reports, establishing acceptance criteria, and conducting statistical analyses.
- Maintain the site's Quality Systems in alignment with ISO standards and regulatory requirements.
- Drive continuous improvement initiatives across all areas, implementing changes and verifying their effectiveness.
- Support internal and external audits, including those conducted by customers and suppliers.
- Perform Quality Assurance duties as necessary to assist manufacturing operations and material release.
- Draft or update standard operating procedures and quality system documentation as needed.
- Prepare technical documentation, including investigation summaries and change management records.
Qualifications – Skills and Knowledge:
- Required: Bachelor of Science (BS) Degree in a scientific or engineering discipline; a Master’s degree (MS) is advantageous.
- A minimum of 6 years of experience in a Quality Engineering role, preferably within a cGMP Biotech or Life Sciences environment.
- Demonstrated experience with titration and pH testing.
- Excellent verbal and written communication skills in English.
- Proficient in technical and statistical writing.
- Experience with ISO-9001:2015 (ISO 13485 preferred) and DEA compliance.
- Able to function effectively in a matrix organization.
- Comprehensive understanding of quality systems and their development, documentation, and implementation in accordance with domestic and international standards.
- Familiarity with the audit process, including planning, execution, reporting, and follow-up.
- Strong analytical, problem-solving, judgment, and decision-making abilities.
- Safety equipment usage is required, including safety glasses and gloves.
- Proven ability to conduct quality investigations, including root cause analysis and corrective/preventive action determination.
- Validation expertise, including knowledge of product, process, and equipment qualifications (IQ/OQ/PQ).
- Strong data analysis skills, with the ability to apply statistical methods for quality investigations.
- Lean Sigma Green or Black Belt certification is a plus.
- ASQ CQE certification is a plus.
- Exceptional organizational skills with a keen attention to detail.
- Ability to manage multiple tasks efficiently to meet production demands.
- Proficient in Microsoft Office applications (Word, Excel, PowerPoint).
Company Overview:
Infojini Consulting is a staffing and recruitment firm based in Baltimore, MD, specializing in providing services to various healthcare institutions, wellness centers, pharmacies, and medical facilities across the United States.
