QC Data Quality Lead — 1st Shift, On‑Site

Alcami Corporation

Morrisville (NC)

On-site

USD 90,000 - 120,000

Full time

7 days ago
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Job summary

Alcami Corporation seeks a Supervisor, Data Quality Review to lead a fast-paced QA team in a cGMP environment. You will schedule work, develop SOPs, and provide consultation on quality and compliance topics across disciplines.

The role requires a Bachelor’s degree in pharmaceutical sciences or related, 6+ years of pharmaceutical lab experience, and leadership ability. On-site with travel up to 5%, you will drive continuous improvement and audit readiness.

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 regarding quality issues, audits, and inspections.
  • Collaborates with other supervisors in quality, labs, and manufacturing.
  • Oversees distribution of work to achieve department goals.
  • Performs data review of lab documentation, protocols, reports, investigations, test procedures, on schedule with accuracy.
  • Ensures timely completion and compliance with cGMP and training requirements.
  • Attracts, develops, and retains a high performing team through selection, training, coaching, mentoring and performance management.

Skills

Leadership
cGMP knowledge
Data review
Quality systems
Analytical testing
Documentation
Microsoft Office
Empower
MODA
NuGenesis

Education

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

Tools

Empower
MODA
NuGenesis
Microsoft Office

Job description

Alcami Corporation seeks a Supervisor, Data Quality Review to lead a fast-paced QA team in a cGMP environment. You will schedule work, develop SOPs, and provide consultation on quality and compliance topics across disciplines.

The role requires a Bachelor’s degree in pharmaceutical sciences or related, 6+ years of pharmaceutical lab experience, and leadership ability. On-site with travel up to 5%, you will drive continuous improvement and audit readiness.

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