Location: Barceloneta, PR
Pay Rate: $27.75 / Exempt

Summary:
The Senior Investigator writer is responsible for providing quality assurance support for the plant including resolution corrective and preventive action for events, leading and participating in investigations, coordination and leading of local Change Plan, support in complaint investigations, quality improvement programs, and assurance of cGMP and company policy compliance for the manufacturing plant. Understands internal business process, to make appropriate prioritization of their assigned work duties.

Responsibilities:

• Perform exception reports, complaints, PQRs, CP coordination, and trend monitoring systems, ensuring compliance with company Operations policies, plant procedures, and regulations.
• Investigate exception events in manufacturing, incoming laboratory, Quality Control laboratory, validation, microbiology, stability, and complaints areas.
• Conduct consistent and thorough investigations, ensuring proper documentation and timely resolution based on CAPA requirements.
• Perform product quality complaint investigations in compliance with company policies, plant procedures, and regulatory requirements.
• Conduct laboratory investigations for out-of-specification or trending results following compnay procedures and policies.
• Provide support to plant users on Exception Events IT systems.
• Document and coordinate local change plan assessments and strategies with end users and impacted functional areas.
• Generate and review periodic quality metrics related to investigations, complaints, CP, PQRs, and other KPIs as requested by management.
• Support new product processes as a QA investigator/writer and serve as a liaison between company and third-party manufacturers or contractors.
• Provide support during internal and external inspections.
• Execute assigned operational tasks as required by the area.
• Evaluate potential events as the first point of contact on the manufacturing floor and define immediate mitigation actions.
• Comply with EHS management system requirements, promote continuous improvement, and consider EH&S aspects during design and change processes.
• Follow all EHS procedures and policies, including incident reporting, PPE usage, waste management, disposal, and other applicable programs.

Qualifications:

• Bachelor’s degree in Science or Engineering (preferably Biology or Chemistry) with a minimum of four (4) years of experience in a quality or technical role within the pharmaceutical or biotechnology industry.
• Master’s degree in Science or Engineering (preferably Biology or Chemistry) with a minimum of two (2) years of experience in a quality or technical role within the pharmaceutical or biotechnology industry.
• Certification on Root Cause Analysis in pharmaceutical process, preferred.
• Advanced knowledge and prior exposure to technical and operational processes required to perform job responsibilities effectively.
• Knowledge of GMP and safety regulations.
• Effective verbal and written communication skills in both English and Spanish.
• Prior experience with CAPA, including authoring and approving laboratory and manufacturing investigations.
• Experience with other quality systems (e.g., change management, risk management documentation) is preferred.
• Strong interpersonal and communication skills.
• Strong problem-solving skills.
• Ability to manage multiple priorities simultaneously.

 
 
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: $ 27.75/hr.