Onsite QA Specialist II - Relocation Support (New York)

Hartmann Young; New York (NY); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

Hartmann Young, a global contract development and manufacturing organisation, seeks a QA Specialist II in New York for on-site quality assurance oversight of cGMP operations. You will manage deviations, review QC testing, and ensure documentation and regulatory compliance on the floor.

The role emphasizes QA oversight, issuance of CAPAs, and participation in internal and client audits, with relocation support available for this opportunity in New York.

Qualifications

• Requires a BA/BS in Chemistry or a relevant field with 3 years of related work experience in pharmaceutical, biotechnology, medical device, and/or cGMP FDA-regulated industry OR MA/MS with 1 year of related work experience.
• Strong familiarity with regulatory requirements of ICH Q7, Q9, Q10, and/or 21CFR210 and 211.

Responsibilities

• Represent company Quality Assurance when managing issues that require immediate corrective action.
• Review quality control testing for compliance with internal SOPs and specifications.
• Report back to appropriate management as to personnel performance, highlighting those areas in need of improvement as well as those exceeding expectations.
• Author, review, and/or approve Quality Management System documents, including change controls, SOPs, deviations, CAPAs, etc.
• Perform and/or participate in internal audits, external audits, investigations, and/or inspections.
• With supervision, may respond or manage responses to clients regarding manufacturing, testing and/or documentation issues.
• May develop and/or maintain Quality System metrics for management review.
• Provide on the floor support to operations, including coordinating and performing day to day activities as needed.
• May assist in developing and conducting training of personnel to execute production in full accordance with cGMP’s and quality systems to ensure real-time compliance.
• May perform QA visual inspection activities when required.
• Participate in regulatory and client audits.
• Other duties as assigned.

Skills

Quality Assurance

cGMP knowledge

Regulatory compliance

Documentation

Education

BA/BS Degree in Chemistry or a relevant field

MA/MS Degree in Chemistry or a relevant field

Job description

Hartmann Young, a global contract development and manufacturing organisation, seeks a QA Specialist II in New York for on-site quality assurance oversight of cGMP operations. You will manage deviations, review QC testing, and ensure documentation and regulatory compliance on the floor.

The role emphasizes QA oversight, issuance of CAPAs, and participation in internal and client audits, with relocation support available for this opportunity in New York.