Alcami is seeking a Sr. Quality Specialist for cGMP manufacturing, working on a weekend schedule from Friday to Monday in Morrisville, NC. The role focuses on ensuring quality and compliance in a fast-paced environment, requiring extensive experience in GMP and aseptic parenteral manufacturing
Job Summary
The Senior Quality Assurance Specialist is accountable for driving results in a fast-paced environment by ensuring quality and compliance with applicable regulatory requirements.
This role involves performing visual inspection of parenteral products which requires specific qualification and maintaining accurate quality databases.
Alcami offers a competitive salary, exceptional benefits package including medical, dental, vision, and 401(k) with immediate vesting.
Matching Summary
Match Score: 85
Alcami is seeking a Sr. Quality Specialist for cGMP manufacturing, working on a weekend schedule from Friday to Monday in Morrisville, NC. The role focuses on ensuring quality and compliance in a fast-paced environment, requiring extensive experience in GMP and aseptic parenteral manufacturing.
Salary
Not specified; Competitive salary mentioned; Benefits include medical, dental, vision, 401(k) with match
Skills & Requirements
Must-have
cGMP regulatory compliance experience
Aseptic parenteral manufacturing knowledge
Visual inspection qualification required
Grade C gowning proficiency
Batch record creation and issuance
Internal audit execution skills
Nice-to-have
Mentoring operations personnel
SOP development assistance
Client consultation capabilities
Process improvement initiatives
Vendor management support
Key Requirements
Bachelor's degree in Chemistry or Biology
10+ years of GMP related experience
Master's degree in related field as alternative
Minimum five years of related work experience
20/20 corrected vision for Visual Inspector qualification