On-Site Quality & Compliance Specialist — Night Shift

Alcami-5; Morrisville (NC); On-site; USD 70,000 - 90,000; Full time

Job summary

Alcami is seeking a Quality Specialist to provide on-site quality support in a fast-paced environment, ensuring compliance with cGMP and regulatory requirements. The role includes document reviews, audits, data trending, and training within the site’s quality management systems.

Responsibilities cover on-floor manufacturing support, complex data reviews, client and regulator inspections, SOP development, and quality improvements across the lab or manufacturing facility, with 12-hour night shifts

Qualifications

• Bachelor’s degree in Chemistry, Biology, or relevant field and 3+ years of related experience required, or Master’s degree and 1+ years of related experience.
• Relevant GMP experience required.
• Experience in Environmental monitoring and critical utilities preferred for sterile operations.

Responsibilities

• Support manufacturing processes on the floor.
• Performs quality review and approval of complex documents, all types of data, protocols, and/or reports.
• Supports quality floor audits and/or floor inspections.
• Supports for client and regulatory agency audits and inspections.
• Provides quality evaluation and release of support materials, products, equipment and facilities as required.
• Maintains quality databases and may perform analysis and trending.
• Assists with quality improvement initiatives as needed.
• Develops quality SOPs or other quality documents and/or reports as needed.
• Provides consultation on complex quality and compliance topics in areas of expertise.
• Develops and provides training in quality and compliance topics in areas of expertise.
• Provides Quality oversite for the site specific Quality Management Systems including Investigations, Corrective Actions, Change control, etc.

Skills

GMP knowledge

Communication skills

Math skills

Computer skills

Independent worker

Client interaction

Education

Bachelor's degree in Chemistry, Biology, or relevant field

Master's degree in relevant field

Job description

Alcami is seeking a Quality Specialist to provide on-site quality support in a fast-paced environment, ensuring compliance with cGMP and regulatory requirements. The role includes document reviews, audits, data trending, and training within the site’s quality management systems.

Responsibilities cover on-floor manufacturing support, complex data reviews, client and regulator inspections, SOP development, and quality improvements across the lab or manufacturing facility, with 12-hour night shifts