Quality Assurance Specialist II

Hartmann Young; New York (NY); On-site; USD 85,000 - 110,000; Full time

Job summary

Hartmann Young partners with a global contract development and manufacturing organization to recruit a QA Specialist II in New York. This role provides on-the-floor QA presence, ensuring adherence to cGMP and quality systems while identifying and addressing deviations with proper documentation.

The candidate will review QC testing against SOPs, report on personnel performance, author and approve QMS documents, and participate in audits and regulatory inspections.

Qualifications

• BA/BS in Chemistry or MA/MS in Chemistry with related pharmaceutical/cGMP experience.
• Experience maintaining quality systems and ability to identify compliance risks.
• On-the-floor QA presence and proactive deviation prevention required.

Responsibilities

• Represent QA when immediate corrective action is needed and ensure proper documentation.
• Review QC testing for compliance with SOPs and specifications.
• Report personnel performance and highlight areas for improvement or excellence.
• Author/review/approve Quality Management System documents (change controls, SOPs, deviations, CAPAs).
• Participate in internal audits, external audits, investigations, and inspections.
• Respond to clients regarding manufacturing, testing or documentation issues with supervision.
• Develop or maintain Quality System metrics for management review.
• Provide on-the-floor QA support to operations and coordinate day-to-day activities.

Skills

QA on-the-floor

cGMP knowledge

Audits

CAPA management

SOP documentation

ICH Guidelines

21 CFR 210/211

Quality metrics

Training

Education

BS in Chemistry

MS in Chemistry

Job description

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.

If this is an opportunity of interest, please reach out or apply. We'd love to hear from you!

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