Role overview

Qualifications

Proven experience as a Life Sciences consultant in cGMP pharmaceutical or biotech settings.
Strong knowledge of CSV, CFR Part 11, Data Integrity/Governance, CAPA, and FDA remediation.
Experience with commissioning and qualification, quality system implementation, and SOP/policy development.
Willingness to work on a 1099 contracting basis across the US and availability for immediate or future assignments.

Responsibilities

Provide consulting support across compliance, training, and quality systems in cGMP environments, including CSV and data integrity governance.
Lead or support investigations and deviations, CAPA, FDA remediation, audits/assessments, and mock FDA inspections.
Assist with commissioning and qualification activities, quality system implementation, and SOP/policy development.
Support MA due diligence and license application activities; collaborate with clients and Talent Acquisition to scope assignments.

Key facts

Remote from: United States
Freelance
Consultant
English

Hard skills

Computer System Validation Data Integrity Data Governance Title 47 CFR Part 15 Commissioning Corrective And Preventive Action (CAPA) FDA Regulations Auditing Educational Assessment Policy Development Due Diligence End-User License Agreement

Other skills

Investigation
Training And Development
Consulting

About the company

MEDVACON LIFE SCIENCES, LLC

Pharmaceuticals

MEDVACON is a renowned company recognized globally for providing tailored FDA Quality Compliance and Technical Consulting Services. With an unwavering commitment, MEDVACON partners with Life Sciences Companies to achieve optimal solutions while effectively managing compliance-related expenditures. MEDVACON’s extensive array of services reflects our dedication to client satisfaction. Our proficiency encompasses Validation, Qualification, Quality Systems, IT Computer System Validation/Software Quality Assurance (CSV/SQA), FDA Audit Preparation, Response and Remediation Services, as well as Training, Tech Transfers, and Project Management. We look forward to partnering and working with you and your organization! MEDVACON, Elevating Excellence

Company details

Company typeSME

IndustryPharmaceuticals

Company size51 - 200

Links

Website LinkedIn See all jobs

Your match analysis

See how your profile stacks up against this role.

We compared the job requirements to your profile to show where you're strong and where you fall short.

Job description

We are looking to connect with experienced consultants open to working now or on future assignments in cGMP pharmaceutical or biotech setting on assignments involving:

Compliance and Training
CSV & CFR Part 11
Data Integrity / Governance
Commissioning and Qualification
Quality System Implementation
Compliance ~ cGxP Consulting
Investigation and Deviation – CAPA
FDA Remediation
Audits and Assessments
Mock FDA Inspections
SOP / Policy Development
M&A Due Diligence
License Application Support

While we are headquartered in Sparta, NJ, we continually have a high number of consulting and contracting assignments on 1099 across the US.

A member of our Talent team will be in touch to discuss your application in more detail. In the meantime, check out our website: Home — Medvacon Life Sciences LLC

Quality Grind Podcast: Quality Grind Podcast — Medvacon Life Sciences LLC

Blog Series: Blog — Medvacon Life Sciences LLC

Important Notice: Protecting Your Information
Medvacon Talent Acquisition only conducts initial video interviews via Microsoft Teams or Zoom. All communication will come from an email address ending in @medvacon.com. If you receive a message that seems suspicious or is not from our official domain, please report it immediately to jobs@medvacon.com.