Quality & CAPA Specialist for GMP Facilities

Trinity Consultants; City of Albany (NY); On-site; USD 70,000 - 90,000; Full time

Job summary

An engineering and consulting firm is seeking a qualified individual for a Compliance Specialist role focused on CAPA management within the pharmaceutical industry. You will be responsible for liaising with the Facilities Department, managing CAPA programs, and facilitating cross-functional meetings. Ideal candidates should have a Bachelor’s degree and at least 5 years of experience in QA or compliance, with strong technical skills and familiarity with regulatory requirements. This role offers an opportunity to work in a collaborative environment in Albany, New York.

Qualifications

• At least 5 years of related work experience in a QA or Compliance setting.
• Familiar with equipment used in pharmaceutical production, including bioreactors and chromatography skids.

Responsibilities

• Acts as a liaison between the Facilities Department and onsite quality and regulatory groups.
• Manages and participates in Facilities Department CAPA Program.
• Daily monitoring and tracking of CAPAs assigned to the facilities department.
• Facilitates cross-functional meetings regarding CAPA ownership.
• Provides support and training for Facilities personnel.

Skills

Strong technical aptitude

Preventative maintenance experience

Data analysis skills

Well-developed communication skills

Outstanding organization skills

Strong GMP background

Education

Bachelor’s Degree in Engineering, Biology, or equivalent

Tools

Computerized Maintenance Management System (BMRAM)

QUMAS

Excel

Job description

An engineering and consulting firm is seeking a qualified individual for a Compliance Specialist role focused on CAPA management within the pharmaceutical industry. You will be responsible for liaising with the Facilities Department, managing CAPA programs, and facilitating cross-functional meetings. Ideal candidates should have a Bachelor’s degree and at least 5 years of experience in QA or compliance, with strong technical skills and familiarity with regulatory requirements. This role offers an opportunity to work in a collaborative environment in Albany, New York.