Location: Barceloneta, PR
Shifts: Must have full availability to work rotating shifts based on business needs. Work schedules are subject to change and may include, but are not limited to, the following shifts:

• 1st shift:  8:00am - 5:00pm (Monday - Friday)
• Overtime as per businees operational needs.

 

Purpose :
Responsible for implementing and maintaining the eff ectiveness of the Quality System.Support manufacturing operations in the resolution of events, impact assessment anddocumentation discrepancies. Provide guidance for product/process impact analysis,perform holistic evaluation of events, review and approve investigations and risk basedevaluations in support to routine operations and product disposition.

Responsibilities:

• Support routine operations to ensure that all quality goals are met, and allpractices and procedures comply with company policies and applicable regulationsfor the Quality areas under responsibility. Serve as backup for the QA Managerleading the team and providing support to quality initiatives.
• Ensures investigations of plant events are evaluated in a timely manner;completed thoroughly and documented accurately in the plant CAPA system.
• Performs product impact analyses for plant events and places product on QA holdwhere appropriate.
• Participates on the Validation Review Board as the Manufacturing QualityAssurance function.
• Approves standard operating procedures; change management and riskmanagement documents.
• Ensures all documents are in compliance with company global procedures and regulatory requirements.
• Approves calibration requests, calibration out of tolerance and preventivemaintenance records.
• Ensures that these documents have appropriatejustifi cations according to product /process limits established.
• Demonstrates accountability and responsibility of EHS performance andcompliance.
• Maintains an eff ective liaison and cooperative relationship with other Qualityareas and Plant departments. Oversees manufacturing operations to ensurepractices are in alignment with approved procedures.
• Provide support to the Compliance team during internal and external audits asrequired.
• Provide guidance for new product introduction activities.
• Develop risk assessments to support manufacturing activities for new products and ensurematerial control until regulatory approval.
• Conform to EHS management system requirements and compliance obligations,promote continuous improvement, and consider EHS aspects during the designand change process.
• Comply with all EHS procedures and policies includingincident reporting, use of PPE, waste management and disposal, and any otherprogram applicable according to the position duties.

Requirements:

• Bachelors degree in Science: Biotechnology, Biology, Microbiology, Chemistry or Engineering.
• Four (4) years of experience in Pharmaceutical/Biotechnology industry in a similar positions.
• This position requires knowledge of quality / compliance /Investigations /Risk management as well as regulations and standards affecting biological products.
• New Product Introduction – experienced Quality representative to support manufacturing and technical operations for the introduction of new biological products filled under aseptic processing conditions. 
• Required experience in parenteral filling operations for sterile drug products. 
• Knowledgeable in the following aspects GMP, Media Fills, Process validation (PPQ), Smoke Studies, CAPA/Investigations, Root Cause Analysis, Change Management, Risk Management, Annex 1 and FDA regulatory guidelines.   
• Responsibilities include, develop, review and approval of protocols, technical reports, investigations, procedures, risk assessments. 
• Provide guidance to cross functional team on the requirements and compliance aspects governing the new product introductions.
• Excellent written and spoken communication skills in English and Spanish.
• ?Teamwork and time management skills
• Knowledge of GMP, safety regulations.
• Quality/compliance management skills.
• Fast paced and adaptable to continuously changing environment.
• ubject to work with multiple priorities and interruptions and under reasonable pressure due to the nature and function of the area.

 
 
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.The pay rate for this position is $42.31/hr.