Overview
Quality Specialist Jobs in Sussex County, NJ at Suru
Title: Quality Specialist
Company: Suru
Location: Sussex County, NJ
Job Summary:
We are seeking a meticulous and experienced Quality Assurance Specialist to join our team. This role is crucial in ensuring compliance with international pharmaceutical and biotechnology regulations, with a strong emphasis on maintaining and improving quality systems. The ideal candidate will have a deep understanding of regulatory frameworks, extensive experience with technical documentation, and a proactive approach to quality management in a manufacturing environment.
Key Responsibilities:
Ensure adherence to global regulatory requirements, including ISO standards and FDA regulations, to maintain product quality and compliance.
Develop, review, and manage complex technical documentation related to quality processes and regulatory compliance.
Oversee and contribute to critical quality system functions such as process improvements, non-conformance investigations, regulatory audits, and validation efforts.
Apply statistical process control (SPC) techniques and industry best practices to analyze and optimize manufacturing and quality control processes.
Leverage extensive industry experience and critical thinking to guide decision-making and strategic planning for quality initiatives.
Demonstrate strong organizational and planning abilities to manage multiple projects and priorities effectively.
Communicate clearly and professionally across departments, as well as with external partners, to ensure alignment on quality objectives and compliance requirements.
Collaborate within cross-functional teams to drive continuous improvement and maintain a high standard of quality.
Utilize expertise in quality management systems, including deviation handling, document control, product release, and change management, to support business objectives and mitigate risks.
Qualifications & Requirements:
Bachelor’s degree in Engineering, Life Sciences, or a related field.
3-7 years of experience in quality assurance, with a focus on documentation and compliance in regulated industries such as pharmaceuticals or medical devices.
In-depth knowledge of industry regulations, including ISO 9001, ISO 13485, and FDA 21 CFR Parts 210, 211, and 820.
Strong background in managing quality systems, including CAPA, audits, process validation, and change control.
Proficiency in statistical analysis and SPC methodologies to support quality improvements.
Excellent analytical and problem-solving skills with a keen attention to detail.
Exceptional written and verbal communication skills with the ability to work effectively across teams and with external partners.
Proven ability to work independently and collaboratively in a fast-paced, team-oriented environment.
Experience with quality management software and electronic documentation systems is a plus.
Benefits:
11 holidays per year
Our Client pays 100% for your Long-Term (LTD) and Short-Term Disability (STD), Basic Term Life and Accidental Death and Dismemberment (AD&D) insurance, and Employee Assistance Program (EAP).
3% match on 401k
15 days (120 hours) of Paid Time Off
