Overview
Quality Assurance Specialist Jobs in Pennsauken, NJ at Planet Pharma
Title: Quality Assurance Specialist
Company: Planet Pharma
Location: Pennsauken, NJ
Location: Pennsauken, NJ
Work Arrangement: 100% On-Site
Position Summary
We are seeking a Quality Assurance Specialist to support quality systems and compliance activities within a regulated manufacturing environment. This hands-on role is responsible for maintaining and improving Quality Management System (QMS) processes, supporting investigations, managing documentation, and partnering cross-functionally to ensure compliance with industry standards and customer expectations.
This position offers the opportunity to work in a modern manufacturing environment supporting continuous improvement, compliance initiatives, and quality-focused projects.
Key Responsibilities
- Maintain and support Quality Management System (QMS) processes and documentation.
- Lead or support investigations related to customer complaints, nonconformances, deviations, and quality events.
- Perform root cause analyses and drive corrective and preventive actions (CAPA) through implementation and closure.
- Support change control activities and ensure proper follow-through of quality processes.
- Write investigation reports, quality documentation, and compliance-related records.
- Partner with Operations, Engineering, Supply Chain, and other functional teams to resolve quality issues.
- Assist with internal and external audits, including preparation, execution, and corrective action follow-up.
- Support quality improvement initiatives and compliance projects.
- Ensure controlled documents remain current and compliant with established procedures and standards.
Required Qualifications
- Bachelor's degree preferred.
- 3-5 years of Quality Assurance experience in a regulated manufacturing environment.
- Experience managing or supporting CAPA, Change Control, Complaint Handling, and investigation processes.
- Strong root cause analysis and problem-solving skills.
- Experience writing quality reports, investigations, and controlled documentation.
- Knowledge of GMP/cGMP requirements and industry quality standards.
- Ability to manage multiple priorities, meet deadlines, and work independently.
- Strong verbal and written communication skills.
Preferred Qualifications
- Experience supporting customer, supplier, ISO, or regulatory audits.
- Knowledge of ISO 9001 and/or ISO 15378 standards.
- Experience working in cleanroom or classified manufacturing environments.
- Customer-facing quality experience.
