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• Duration: 6+ month contract, potential for extension or conversion
• Pay rate: $65-$75/hr
• Job Location: Remote, USA
• Schedule: M-F, EST time zone working hours

SENIOR SPECIALIST, GMP QUALITY

Position Summary

The Senior Specialist, GMP Quality will support Quality Unit activities and quality oversight efforts associated with internal operations and external manufacturing partners. This role is responsible for ensuring clinical and commercial products meet established quality requirements and are released in compliance with applicable regulations, quality standards, and internal procedures.

Key Responsibilities

• Review pre-executed and executed batch records for API, bulk drug product, and finished drug product to ensure adherence to approved procedures and product specifications.

• Perform product disposition activities for clinical and commercial materials in accordance with quality standards and applicable regulatory requirements.

• Support review of regulatory documentation to ensure accuracy and consistency with source data.

• Process and maintain Product Quality Complaints as required.

• Assist with the drafting, review, and revision of Quality Agreements.

• Collaborate with analytical and technical teams to perform GMP reviews of stability studies, analytical testing, method validations, and method transfers.

• Identify and recommend improvements to Quality Systems to enhance compliance, effectiveness, and operational efficiency.

• Provide quality oversight for deviations, product impact assessments, root cause investigations, CAPA activities, and change control processes within electronic Quality Management Systems.

• Support internal audits, supplier audits, and regulatory inspections as needed.

• Ensure quality records are maintained accurately and in compliance with GMP requirements.

Qualifications

• Bachelor's degree in Life Sciences, Chemistry, Biochemistry, or a related scientific discipline required; advanced degree preferred.

• Minimum of 7 years of Quality Assurance experience within the pharmaceutical, biotechnology, or related regulated industry.

• Experience supporting Chemistry, Manufacturing, and Controls (CMC) activities and regulatory submissions.

• Strong understanding of product development and manufacturing processes from early development through commercialization.

• Knowledge of FDA cGMP regulations, ICH guidelines, EU GMP requirements, and other applicable pharmaceutical regulations.

• Experience supporting deviation investigations, CAPA management, change control, batch record review, and product release activities.

• Strong written and verbal communication skills with the ability to work independently and collaborate effectively across cross-functional teams.

• Experience with small molecule products and oral dosage forms is preferred.

• Hands-on analytical laboratory or Quality Control experience is a plus.

• Experience with electronic Quality Management Systems (eQMS) such as Veeva or similar platforms is preferred.