Senior QA Document Control Lead — FDA/cGMP MasterControl

Zachary Piper Solutions; Elkridge, Northern (MD, KY); Hybrid; USD 95,000 - 100,000; Full time

Benefits offered by this job

PTO

Paid Holidays

Medical

Dental

Vision

401K

Tuition Reimbursement

Paid Maternity Leave

Military Reserve Pay Offset

Job summary

Zachary Piper Solutions seeks a QA Document Control Manager to support a pharmaceutical manufacturing organization onsite in Elkridge, MD. This role works in a regulated FDA and cGMP environment with ample opportunity for long-term growth.

You will lead the Document Control team, administer and maintain the eDMS (MasterControl preferred), review SOPs, and prepare for regulatory audits and FDA inspections. Ideal candidates bring a Bachelor's in a scientific discipline, 8+ years GMP experience,

Qualifications

• Bachelor's degree in a scientific discipline or equivalent experience.
• 8+ years of experience in a GMP-regulated environment.
• Experience working in an FDA-regulated environment.
• Strong knowledge of cGMP regulations and quality systems.
• Experience with eDMS platforms; MasterControl preferred.
• Previous leadership or people management experience.
• Strong technical writing and documentation skills.

Responsibilities

• Manage daily activities of the Document Control team.
• Administer and maintain the eDMS system (MasterControl preferred).
• Review and approve SOPs, protocols, forms, and GMP documentation.
• Support regulatory audits and FDA inspections.
• Maintain training records and document control processes.
• Partner with cross-functional teams to ensure compliance.
• Identify and implement process improvements.

Skills

Leadership

Technical writing

Regulatory compliance

GMP knowledge

Education

Bachelor's degree in a scientific discipline

Tools

MasterControl

Job description

Zachary Piper Solutions seeks a QA Document Control Manager to support a pharmaceutical manufacturing organization onsite in Elkridge, MD. This role works in a regulated FDA and cGMP environment with ample opportunity for long-term growth.

You will lead the Document Control team, administer and maintain the eDMS (MasterControl preferred), review SOPs, and prepare for regulatory audits and FDA inspections. Ideal candidates bring a Bachelor's in a scientific discipline, 8+ years GMP experience,