What are the responsibilities and job description for the Senior Quality Assurance Specialist position at United Pharma?
Senior Quality Assurance Specialist
Location: New Jersey NJ Pennsylvania PA North Carolina NC Onsite or Hybrid
About the Role
We are seeking a Senior Quality Assurance Specialist with extensive experience in pharmaceutical manufacturing and quality systems. This role is responsible for ensuring compliance with regulatory requirements and maintaining the highest standards of product quality across operations. The ideal candidate will have strong experience working in GMP regulated environments and will play a key role in driving quality excellence and continuous improvement initiatives
Key Responsibilities:
Ensure compliance with FDA regulations GMP guidelines and company quality standards across manufacturing and quality operations
Lead and support quality system activities including deviations CAPA change control and investigations
Review approve and maintain SOPs protocols and quality documentation
Participate in risk assessments and implement corrective and preventive actions to improve processes
Provide guidance and mentorship to junior QA team members
Required Qualifications:
Bachelors degree in Life Sciences Pharmacy Chemistry or related field
Minimum 8 plus years of experience in Quality Assurance within the pharmaceutical industry
Strong knowledge of GMP FDA regulations and global regulatory standards
Hands on experience with quality systems including deviations CAPA change control and audit management
Experience in batch record review and validation processes
Preferred Qualifications:
Experience with regulatory inspections and audit management
Familiarity with electronic quality management systems
Lean Manufacturing or Six Sigma certification is a plus
Experience working in sterile or biologics manufacturing environments
Work Authorization:
This role is strictly W2 only no C2C or third party candidates