Senior Quality Analyst

Artech-Information-Systems-L.l.c.; Barceloneta (PR); On-site; USD 50,000 - 57,000; Full time

Job summary

Artech-Information-Systems-L.l.c. seeks a QA Specialist III / Senior Quality Analyst to implement and maintain the Quality System and support manufacturing operations in event resolution, impact assessment, and documentation discrepancies.

Experience in GMP, CAPA investigations, risk assessment, and regulatory guidelines is required. Bilingual English/Spanish and a degree in biotechnology or related field are preferred; masters are a plus. Onsite in Barceloneta, PR.

Qualifications

• Bachelor's degree in Biotechnology, Biology, Chemistry or Engineering.
• Four (4) years of experience in Pharmaceutical/Biotechnology industry in a similar position.
• Knowledge of GMP, safety regulations.
• Excellent written and spoken communication skills in English and Spanish.
• Quality/compliance management skills.

Responsibilities

• Support routine operations to ensure that all quality goals are met, and all practices and procedures comply with Client 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.
• 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 Client global procedures and regulatory requirements.

Skills

Fully bilingual

Teamwork

Time management

Education

Bachelor’s degree in Biotechnology, Biology, Chemistry or Engineering

Master's degree in Science preferred

Job description

Title

QA Specialist III / Senior Quality Analyst

Location

Barceloneta, PR – 100% Onsite

Duration

12+ months

Pay Range

$36/hr to $41.43/hr

Schedule

1st shift – 8-5 – 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 of routine operations and product disposition.

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. Assures the quality of manufactured products and processes per standard operating processes (SOP'S) and GMP (Good Manufacturing Practices). Degree not required.

Responsibilities

• Support routine operations to ensure that all quality goals are met, and all practices and procedures comply with Client 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 Client 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

• Bachelors degree in Biotechnology, Biology, Chemistry or Engineering. Masters 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.

Top 3–5 Required Skills, Experience or Education

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

Additional Required Qualifications

• 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.

Nice to Have (But Not Required)

• Experience in parenteral and biotechnology plants
• Biotechnology de Downstream Off stream

Work Environment

Production areas and Office environment to perform inspections.

Overtime

Maybe in extraordinary cases.

Work Arrangement

Onsite

Interview Process

Number of Interview Rounds: 1 or 2nd round if needed

Interview Type: Onsite preferred

Key Stakeholders

Manufacturing Operations, Quality, Compliance Departments

Experience Level

5–7 Years