Job Description

Job Description

Job Description

We are looking for a Quality Assurance Specialist to support the implementation and maintenance of quality systems in compliance with FDA Regulations and the current Good Manufacturing Practices (cGMP). This is a contract-based opportunity for an independent professional willing to work on a hybrid environment (50% remote, 50% visiting client sites).

Main Responsibilities:

• Plan, execute, and oversee product inspection and testing for quality and conformance to specifications and deliverables.
• Review and approve manufacturing batch records, laboratory data, and quality documentation.
• Support investigations of deviations, non-conformances, and complaints; ensure timely and effective CAPA implementation.
• Participate in internal audits and inspection readiness activities.
• Assist in the development, revision, and control of SOPs, Policies, and quality documents.
• Monitor and enforce compliance with cGMP, FDA regulations, and company standards.
• Collaborate with cross-functional teams including manufacturing, Quality Control, Engineering, Regulatory Affairs, and Technical Services.
• Support change control processes and ensure proper documentation and risk assessment.
• Maintain QA metrics and contribute to continuous improvement initiatives.

General Requirements:

• Fluent in Spanish and English (spoken and written).
• Proficiency in Microsoft Office 365 (Teams, SharePoint, Outlook, Excel, Word, PowerPoint) and project management tools.
• Excellent communication skills.
• Strong knowledge of FDA Regulations, cGMP, and ICH guidelines.
• Excellent attention to detail and organizational skills.

Education Requirements:

• Bachelor’s Degree in life sciences, engineering, or other related fields.

Experience Requirements:

• 7+ years of experience in Quality Assurance within the pharmaceutical industry.
• Experience with all processes related to Quality Assurance within the pharmaceutical industry, including but not limited to: document control, change controls, investigations and CAPAs, risk assessments, protocols approvals, SOPs and batch records approval processes.
• Experience managing internal and external audits.

Physical Requirements:

• Ability to sit for long periods.
• Light physical activity may be required occasionally.
• Must be able to visit field locations as needed.
• Must be able to use personal protective equipment (PPE) when required.
• Ability to perform in a variety of industrial environments.

Job Tags

Similar Jobs