Senior Quality Assurance Specialist
6 days ago
PSC Biotech is a leading provider of essential services to the life sciences industry, ensuring that healthcare products meet the highest standards and regulatory requirements. We are seeking an experienced Quality Engineer to join our team.
About the Role
The successful candidate will be responsible for ensuring quality standards in production and validation processes, implementing process improvements, and conducting thorough investigations, risk management, and corrective action implementation to ensure regulatory compliance. This role requires strong technical knowledge of GMP, FDA regulations, and other relevant industry standards.
Responsibilities
- Provide technical quality, process, and validation expertise and on-the-floor support.
- Monitor and analyze production processes and validation testing to ensure compliance with regulatory requirements.
- Analyze data from validation tests to determine systems and processes meet required criteria and specifications.
- Conduct investigations and root cause analysis to best implement corrective actions for process deviations and quality issues.
- Provide through quality review and approval of required validation lifecycle documentation including commissioning, qualification, validation protocols, reports, records, etc.
- Evaluates non-conformances, performs gap analyses, and takes appropriate action to efficiently resolve deficiencies.
- Collaborate with cross-functional teams to identify and implement process improvements.
Requirements
- Bachelor's degree in Engineering, Life Sciences, or a related field.
- 3-5 years of proven experience in quality, process, and or validation engineering in the pharmaceutical and/or biotech industry.
- Experience with manufacturing process equipment.
- Strong knowledge of GMP, FDA regulations, and other relevant industry standards.
- Proven success in risk management; experienced conducting non-conformance and deviation investigations and executing CAPA implementation.
- Experience with validation lifecycle management and risk-based approaches.
- Excellent analytical and technical problem-solving skills.
- Strong technical writing skills and understanding of full lifecycle documentation (protocols, reports, procedures, risk assessments, specifications and requirements, etc.)
- Effective communication and interpersonal skills.
- Proactive with strong organization, time management, and project management abilities.
- Excellent attention to detail with commitment to quality and compliance.
- We value candidates who are willing and able to travel as needed for project assignments and client engagements.
Compensation
This W2 Temp position offers a competitive salary range of $80,000 - $110,000 per annum, depending on experience. Additionally, you will receive medical and sick time benefits.
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