QA Specialist III

Responsibilities include, provide guidance to cross functional team on the requirements and compliance aspects governing the changes to operational procedures in a fast pace project for optimization of procedures with the focus of reducing Human Error, review and approval of procedures and associated change records. Knowledgeable in the following aspects GMP, Process validation, CAPA/Investigations, Root Cause Analysis, Change Management, Risk Management, Annex 1 and FDA regulatory guidelines.

Job Title: Senior Quality Analyst
Location: Barceloneta, PR
Contract Length: 12 months with possible extension
Pay Range: $38-$41.43/hr
1st shift, 8 AM - 5 PM, Monday to Friday

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

Responsibilities:

• Support routine operations to ensure that all quality goals are met, and all practices and procedures comply with Clients policies and applicable regulations for the Quality areas under responsibility. Serve as backup for the QA Manager leading 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 hold where appropriate.
• Participates on the Validation Review Board as the Manufacturing Quality Assurance function.
• Approves standard operating procedures, change management and risk management documents. Ensures all documents are in compliance with company global procedures and regulatory requirements.
• Approves calibration requests, calibration out of tolerance and preventive maintenance records. Ensures that these documents have appropriate justifications according to product/process limits established.
• Demonstrates accountability and responsibility of EHS performance and compliance.
• Maintains an effective liaison and cooperative relationship with other Quality areas and Plant departments.
• Oversees manufacturing operations to ensure practices are in alignment with approved procedures.
• Provide support to the Compliance team during internal and external audits as required.
• Provide guidance for new product introduction activities. Develop risk assessments to support manufacturing activities for new products and ensure material control until regulatory approval.
• Conform to EHS management system requirements and compliance obligations, promote continuous improvement, and consider EHS aspects during the design and change process. Comply with all EHS procedures and policies including incident reporting, use of PPE, waste management and disposal, and any other program applicable according to the position duties.

Qualifications:

• Bachelor’s degree in biotechnology, Biology, Chemistry or Engineering. Master’s Degree in Science preferred.
• Four (4) years of experience in Pharmaceutical/Biotechnology industry in a similar position.
• This position requires knowledge of quality / compliance /Investigations /Risk management as well as regulations and standards affecting biological products.
• Excellent written and spoken communication skills in English and Spanish.
• Knowledge of GMP, safety regulations.
• Quality/compliance management skills.
• Fast paced and adaptable to continuously changing environment. Subject to work with multiple priorities and interruptions and under reasonable pressure due to the nature and function of the area.

SOP optimization project

• Experienced Quality representative to support Biologic Bulk Drug Substance manufacturing operations. Required experience in drug substance operations.
• Knowledgeable in the following aspects GMP, Process validation, CAPA/Investigations, Root Cause Analysis, Change Management, Risk Management, Annex 1 and FDA regulatory guidelines.
• Responsibilities include, provide guidance to cross functional team on the requirements and compliance aspects governing the changes to operational procedures in a fast pace project for optimization of procedures with the focus of reducing Human Error, review and approval of procedures and associated change records.
• Capable to work under minimum supervision, with critical timelines and commitments.

Nice to Have:
Experience in parenteral and biotechnology plants Biotechnology de Downstream Off stream

Top Skills:

• Bachelor’s degree on sciences, microbiology or Engineer Experience in Quality preferably evaluating and conducting investigations
• Fully Bilingual Teamwork and time management skills

• Bachelors degree in Biotechnology, Biology, Chemistry or Engineering.
• Four (4) years of experience in Pharmaceutical/Biotechnology industry in a similar position.
• This position requires knowledge of quality / compliance /Investigations /Risk management as well as regulations and standards affecting biological products.
• Excellent written and spoken communication skills in English and Spanish.
• Knowledge of GMP, safety regulations.
• Quality/compliance management skills.
• Fast paced and adaptable to continuously changing environment. Subject to work with multiple priorities and interruptions and under reasonable pressure due to the nature and function of the area.