Quality Analyst: CAPA & Compliance for Biotech Ops

Kelly Services; Barceloneta (PR); On-site; USD 70,000 - 90,000; Full time

Job summary

Kelly Services is seeking a Quality Analyst in the Barceloneta, PR area to implement and maintain the Quality System and support manufacturing operations. You will review investigations, perform risk assessments, and ensure product disposition aligns with regulatory requirements.

The ideal candidate has a Bachelor's in a relevant science, 4 years in pharma/biotech quality, and fluency in English and Spanish.

Qualifications

• Bachelor's degree in biotechnology, biology, chemistry or engineering; master's preferred.
• 4 years experience in pharmaceutical/biotechnology industry.
• Knowledge of GMP and safety regulations; quality/compliance management.
• Excellent written and spoken English and Spanish.

Responsibilities

• Support routine operations to meet quality goals and ensure compliance with Customer 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.
• Investigations of plant events are evaluated in a timely manner; documented 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; approves SOPs, change management and risk management documents; ensures documents comply with global procedures and regulatory requirements.
• Approves calibration requests, calibration out of tolerance and preventive maintenance records with proper justifications.
• Demonstrates accountability and responsibility of EHS performance and compliance.
• Maintains liaison with other Quality areas and Plant departments.
• Oversees manufacturing operations to align with approved procedures.
• Support the Compliance team during internal and external audits.
• Provide guidance for new product introduction activities and develop risk assessments to support manufacturing for new products.
• Conform to EHS management system requirements and promote continuous improvement; comply with all EHS procedures and policies.
• Other program applicable according to position duties.

Skills

GMP knowledge

Quality/compliance management

English and Spanish communication

Investigations / Risk management

Education

Bachelor's degree in biotechnology, biology, chemistry or engineering

Masters degree in science preferred

Job description

Kelly Services is seeking a Quality Analyst in the Barceloneta, PR area to implement and maintain the Quality System and support manufacturing operations. You will review investigations, perform risk assessments, and ensure product disposition aligns with regulatory requirements.

The ideal candidate has a Bachelor's in a relevant science, 4 years in pharma/biotech quality, and fluency in English and Spanish.