Location: Anasco, PR

Responsibilities:

• Develop and implement quality programs, including tracking, analyzing, reporting, and problem-solving.
• Plan, control, and assure product and process quality in accordance with established quality principles such as planning processes, material control, acceptance sampling, and measurement systems.
• Develop technical documentation such as Validation Protocols, Technical/Investigation Reports, SOPs, Validation Plans, Change Controls, and other related documents.
• Qualify new facility additions, including HVAC and water filter systems.
• Ensure compliance with ISO cleanroom standards and FDA regulations in a regulated environment.
• Understand and execute the audit process, including types of audits, planning, preparation, execution, reporting results, and follow-up actions.
• Analyze and acquire data using appropriate standard quantitative methods for process analysis and improvements.
• Work on problem-solving and quality improvement initiatives using various tools and techniques.
• Develop and maintain a thorough understanding of reliability, maintainability, and risk management in relation to quality systems.
• Interact cross-functionally with various departments to ensure compliance and process improvements.

Qualifications:

• BS in Chemical, Biomedical, Mechanical, or Industrial Engineering.
• At least a minimum 5 to 7 years of experience in an FDA-regulated environment.
• Prior experience with ISO cleanrooms.
• Experience with Quality System Regulation (QSR), ISO, Design Control, and Process Validation guidelines.
• Experience in lyophilization and biomaterials is preferred but not required.
• Med device experience is preferred but not required.
• Certifications: ASQ Certified Quality Engineer (CQE) and/or Quality Auditor (CQA) preferred.

Technical Knowledge:

• Knowledge of qualifying new facility additions such as HVAC, water filtration systems.
• Understanding of quality systems development, documentation, and implementation to meet domestic and international standards.
• Basic knowledge of the audit process (planning, preparation, execution, reporting, follow-up).
• Strong understanding of reliability, maintainability, and risk management principles.
• Knowledge in Lean and Six Sigma concepts.
• Familiarity with statistical techniques (SPC, DOE, Process Capability, Gage R & R).
• Experience using Minitab or similar statistical process control tools is preferred.

Skills:

• Strong project management skills.
• Strong technical writing skills.
• Strong problem-solving and analytical thinking skills.
• Proficient in computer software (MS Office, MS Project, VISIO).
• Experience in cGMP, cleaning methods, and validations preferred.
• Ability to work well in a team and independently (self-starter).
• Strong interpersonal and communication skills, with the ability to interact cross-functionally.
• Fully bilingual (English/Spanish).

 

 


At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $43.00/hr.