Senior Quality Analyst / Quality Assurance Specialist II

Job overview

The Senior Quality Analyst / Quality Assurance Specialist II role is onsite in Barceloneta, PR, with a stated pay range of $30–$33.54 per hour. The role supports manufacturing operations and the effectiveness of the Quality System. This position evaluates plant events, product and process impacts, investigations, and risk-based assessments to support routine operations and product disposition. It helps ensure manufacturing practices and documentation meet quality procedures and regulatory requirements.

What you'll do

• Support routine operations and quality goals
• evaluate plant investigations and ensure accurate CAPA documentation
• perform product impact analyses and place products on QA hold where appropriate
• participate in the Validation Review Board
• approve SOPs, change-management and risk-management documents
• review calibration and preventive-maintenance records
• support audits and new product introduction
• oversee alignment with approved procedures
• comply with EHS requirements.

What we're looking for

Skills & competencies

senior quality analyst

quality assurance specialist ii

barceloneta pr

artech

quality system

manufacturing quality

capa

gmp

investigations

risk management

rotating shifts

weekend availability

holiday availability

$30–$33.54/hr

Work arrangement

• Weekend coverage required

Why this role

Four-day, 10-hour schedule with rotation across first, second, and third shifts every two months; availability for shifts, weekends, and holidays is required. Requires a bachelor's degree in biotechnology, biology, chemistry, or engineering and four years of pharmaceutical or biotechnology industry experience in a similar position.

About the employer

Artech LLC is hiring for this role. Industry: Research and Development in Biotechnology (except Nanobiotechnology). Sector: 54.