Quality Assurance Specialist II

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

Please note, this is a full-time onsite position - relocation support is available for this opportunity.

Hartmann Young are currently partnered with a well known, global contract development manufacturing organisation (CDMO), who are looking to expand their team in New York.

Summary:

The Quality Assurance (QA) Specialist II is responsible for maintaining Quality databases and providing an on-the-floor QA presence and oversight to operations. This role includes identifying compliance risks in the operation prior to and during execution, avoiding deviation whenever possible as well as managing immediate corrective action. The QA Specialist II primarily works in the cGMP areas to manage adherence to the quality system and assist in and/or initiate the resolution of deviations.

The role:

• Represent company Quality Assurance when managing issues that require immediate corrective action. Ensure such action taken is appropriate and correctly documented.
• Review quality control testing for compliance with internal SOPs and specifications.
• Report back to appropriate management as to personnel performance, highlighting those areas and individuals in need of improvement as well as those exceeding expectations.
• Author, review, and/or approve Quality Management System documents, including, but not limited to, 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.

Requirements:

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

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