Overview
Quality Engineer Jobs in Newark, NJ at Stark Pharma Solutions Inc
Title: Quality Engineer
Company: Stark Pharma Solutions Inc
Location: Newark, NJ
Hi,
My name is Sravani Dasari from Stark Pharma Solutions Inc. We are hiring talent for our client and are currently working on a Quality Engineer position. Please send me your updated resume if you have relevant experience and are interested in this opportunity. The detailed job description is as follows.
Job Title: Quality Engineer
Location: New Jersey
Duration: Long Term
Position Overview
We are seeking an experienced Quality Engineer to support quality assurance, compliance, validation, and quality systems activities within a pharmaceutical manufacturing environment. This role will focus on ensuring compliance with FDA regulations, cGMP requirements, quality system management, investigations, validation support, and continuous improvement initiatives across manufacturing operations.
Key Responsibilities
Provide quality oversight for manufacturing operations and ensure compliance with cGMP regulations, FDA requirements, and company quality standards.
Manage and support quality system activities, including deviations, CAPAs, change controls, non-conformances, and risk assessments.
Lead and participate in root cause investigations and implement corrective and preventive actions.
Review and approve manufacturing records, SOPs, validation protocols, reports, and GMP documentation.
Support equipment qualification (IQ/OQ/PQ), process validation, cleaning validation, and ongoing process verification activities.
Collaborate with Manufacturing, Engineering, Validation, and Regulatory teams to resolve quality and compliance issues.
Analyze quality metrics and trends to identify opportunities for process improvements and compliance enhancements.
Support internal audits, supplier quality programs, customer audits, and regulatory inspections.
Ensure compliance with 21 CFR Part 210/211, ICH guidelines, GDP, and ALCOA+ data integrity principles.
Promote a culture of quality through training, compliance awareness, and continuous improvement initiatives.
Required Qualifications
Bachelor's Degree in Engineering, Pharmaceutical Sciences, Chemistry, Biology, Life Sciences, or a related technical discipline.
3 5+ years of Quality Engineering, Quality Assurance, Validation, or related experience.
Experience within pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments.
Strong knowledge of quality systems, including deviations, CAPA management, change control, investigations, and risk management.
Experience supporting equipment qualification, process validation, and manufacturing quality oversight.
Understanding of cGMP regulations, FDA requirements, data integrity principles, and inspection readiness activities.
Experience Supporting Regulatory, Customer, Or Third-party Audits Is Preferred.
Strong analytical, problem-solving, technical writing, and communication skills.
Ability to work effectively in a cross-functional team environment.
I am actively connecting with professionals for current and upcoming opportunities. If you are open to exploring new roles or would like to stay informed about relevant positions, please send me your updated resume along with the best number and time to reach you.
Please follow Stark Pharma Solutions on LinkedIn for the latest job updates: https://www.linkedin.com/company/99455976/
