On-Site QC Data Quality Supervisor - First Shift

Alcami-5; Morrisville (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

Alcami in Morrisville, NC, is seeking a Supervisor, Data Quality Review to lead quality review activities in a fast-paced GMP environment. You will schedule work, develop SOPs, and provide consultation on quality and compliance topics.

The role emphasizes building a high-performing team, ensuring timely data reviews of lab documentation, and maintaining cGMP training compliance, with strong collaboration with QA, labs, and manufacturing.

Qualifications

• Bachelor’s degree in Pharmaceutical Sciences, Chemistry, Biochemistry, Microbiology or equivalent required.
• Minimum 6 years of related pharmaceutical laboratory experience in a cGMP environment required.
• 1-2 years of leadership experience preferred.
• Prior CMO or CDMO experience strongly preferred.
• Prior experience in method development/validation and/or transfer/verification, protocols, and troubleshooting required.

Responsibilities

• Interacts with clients and regulatory agencies as needed regarding quality issues, audits, and inspections, and hosts client audits.
• Collaborates with other supervisors in quality, labs, and manufacturing.
• Oversees the distribution of work to ensure efficiency and achievement of department goals.
• Performs data review of lab documentation, protocols, reports, investigations, test procedures, and other documentation on schedule, with accuracy and competency.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Attracts, develops, and retains a high performing team to meet the current and evolving needs of the business through effective selection, training and development, coaching, and mentoring and performance management.

Skills

Leadership

Communication

Presentation

Problem solving

Verbal communication

Education

Bachelor's degree in Pharmaceutical Sciences, Chemistry, Biochemistry, Microbiology or equivalent

Tools

Microsoft Office

Empower

MODA

NuGenesis

HPLC

Job description

Alcami in Morrisville, NC, is seeking a Supervisor, Data Quality Review to lead quality review activities in a fast-paced GMP environment. You will schedule work, develop SOPs, and provide consultation on quality and compliance topics.

The role emphasizes building a high-performing team, ensuring timely data reviews of lab documentation, and maintaining cGMP training compliance, with strong collaboration with QA, labs, and manufacturing.