Quality Project Coordinator

Job Description

Job Description

Job Title: Quality Project Coordinator

Location: Metropolitan Area
Job Type: Full-time
Industry: Pharmaceutical / Medical Devices
Experience Required: 3-5 yrs
Languages: Fluent in English and Spanish

Position Summary:

Smart Precise Solutions, Inc. is seeking a Quality Project Coordinator responsible for leading and supporting investigations related to raw material non-conformances (NCRs) within the manufacturing and packaging areas for diabetes-related products. This role will serve as a liaison between Quality, Engineering, Manufacturing, Suppliers, and other cross-functional teams to ensure timely, thorough, and compliant closure of non-conformance events in accordance with applicable regulatory standards.

Key Responsibilities:

• Coordinate investigations for raw material non-conformances in manufacturing and packaging areas.
• Track and follow up on Corrective and Preventive Actions (CAPAs) associated with NCRs.
• Collaborate with Quality, Engineering, Production, and Procurement teams to gather objective evidence and determine root causes.
• Ensure all documentation is accurate and compliant with internal procedures and regulatory requirements.
• Perform trend analysis and prepare technical reports.
• Participate in internal and external audits, providing information related to NCR investigations.
• Manage project timelines and prioritize tasks to meet investigation deadlines.
• Support continuous improvement initiatives related to raw material quality and process control.

Academic Requirements:

• Bachelor’s degree in Biology, Chemistry, Biomedical Engineering, Chemical Engineering, Industrial Engineering, Materials Science, or a related scientific/engineering discipline.
• A master’s degree is a plus but not required.

Required Experience:

• Minimum of 3 years of experience in a regulated industry (pharmaceutical, medical device, biotechnology).
• Proven experience managing non-conformances, deviations, or material-related complaints.
• Familiarity with manufacturing and packaging processes.
• Hands-on experience with electronic quality systems (e.g., Track Wise, Veeva, Master Control).
• Strong technical writing skills and ability to work cross-functionally.
• Bilingual: Spanish and English (written and spoken at a technical level).

Regulatory Knowledge:

• U.S. Regulations:
  • 21 CFR Parts 210, 211, 820 (GMPs and QSR)
  • 21 CFR Part 11 (electronic records and signatures)
• International Standards:
  • ISO 9001, ISO 13485
  • ICH Q7, Q9, Q10
  • USP/NF
  • Familiarity with EMA, Health Canada, or WHO standards is a plus.

Key Competencies:

• Excellent organizational and multitasking skills.
• Critical thinking and problem-solving abilities.
• Strong interpersonal and communication skills.
• Detail-oriented with a focus on compliance.
• Proficient in project management tools (e.g., MS Project, Smartsheet, JIRA).