QA Document Control Manager

Piper Companies

Elkridge (MD)

On-site

USD 131,809,000 - 137,540,000

Full time

4 days ago
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Benefits offered by this job

Medical
Dental
Vision
401K
PTO
Sick Leave
Holidays

Job summary

Piper Companies in Elkridge, MD is seeking a QA Document Control Manager for a fully onsite role within a global life sciences organization focused on regulated healthcare products. This role oversees document control and quality documentation across regulatory activities, ensuring cGMP compliance.

You will collaborate with cross-functional teams, support audits and inspections, and manage EDMS workflows. The ideal candidate has 8+ years GMP experience and familiarity with FDA-regulated

Qualifications

  • Bachelor’s degree in a relevant area or equivalent work experience.
  • Experience in a FDA regulated environment.
  • 8+ years’ experience in a GMP environment.
  • Knowledge of cGMP and other regulatory requirements applicable to industry.

Responsibilities

  • Oversees document control activities to ensure regulatory and cGMP compliance.
  • Administers the EDMS, including document workflows, approvals, and change controls.
  • Reviews and maintains quality documentation, SOPs, and training records.
  • Partners with cross-functional teams to support compliance and process improvements.
  • Supports audits, inspections, and quality reporting activities.

Skills

GMP experience
cGMP knowledge
Regulatory compliance
Quality documentation experience

Education

Bachelor’s degree or equivalent experience

Job description

Piper Companies is currently looking for a QA Document Control Manager in the Elkridge, MD area to work a fully onsite role. This QA Document Control Manager will join a global life sciences organization focused on the research, development, manufacturing, and commercialization of regulated healthcare products.

Responsibilities for the QA Document Control Manager:
  • Oversees document control activities to ensure regulatory and cGMP compliance.
  • Administers the EDMS, including document workflows, approvals, and change controls.
  • Reviews and maintains quality documentation, SOPs, and training records.
  • Partners with cross-functional teams to support compliance and process improvements.
  • Supports audits, inspections, and quality reporting activities.
Qualifications for the QA Document Control Manager:
  • Bachelor’s degree in a relevant area or equivalent work experience
  • Experience in a FDA regulated environment
  • 8+ years’ experience in a GMP environment
  • Knowledge of cGMP and other regulatory requirements applicable to industry
Compensation for the QA Document Control Manager:
  • Hourly Rate: $46-48/hr based on professional experience
  • Medical
  • Dental
  • Vision
  • 401K
  • PTO
  • Sick Leave as required by law
  • Holidays
Keywords:

Quality Assurance, QA, Quality Management System, cGMP, GMP Compliance, Regulatory Compliance, FDA Regulations, Quality Systems, Change Control, Risk Assessment, Manager, Management, Quality Documentation, Document Control, Document Management, Data, Document Review, Staff Management, Project Coordination, Workflow Optimization, Development, Quality Metrics, Pharma, Pharmaceutical Manufacturing

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