Senior Quality Assurance Specialist

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

Job summary

Hartmann Young partners with a global CDMO to recruit a Senior Quality Assurance Specialist for our New York site. This full-time onsite role focuses on reviewing documents, protocols and reports within the QMS, and interacting with clients on quality issues.

You will assist the QA Manager to ensure regulatory compliance (FDA/EMA/MHRA), conduct investigations of OOS and deviations, lead GMP activities, and coordinate internal and customer audits with CAPA management.

Qualifications

• Bachelor of Science in Chemistry or related field.
• Quality Assurance/Regulatory experience in a pharmaceutical environment (FDA/EMA/MHRA).
• Broad knowledge of cGMP, FDA/ICH guidelines and API regulations.
• USFDA inspection experience (participating or leading).
• Excellent communication and organisational skills; able to work cross-functionally.

Responsibilities

• Assist QA Manager to ensure QMS compliance and regulatory requirements.
• Investigate OOS, Deviations, Change Control, and CAPAs.
• Review/prepare QA documentation, protocols and reports.
• Develop/review/approve quality standards, policies and procedures for cGMP.
• Support regulatory inspections and CAPA preparation; monitor task completion.
• Lead GMP activities and drive deviation investigations with manufacturing managers.
• Report quality metrics and audits; manage master batch records when required.
• Coordinate customer audits and capabilites; provide updates to customers and management.
• Escalate serious compliance gaps to quality management.
• Coordinate internal audits and QA auditor rotations; share quality information across networks.

Skills

Quality Assurance experience

Cross-functional collaboration

Regulatory knowledge

Communication skills

Negotiation & influencing

Audits coordination

Education

Bachelor of Science in Chemistry or related 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 Senior Quality Assurance (QA) Specialist is responsible for the review of various documents, protocols, qualifications and/or reports related to Quality Management Systems. This role interacts with clients for quality related issues, as required. The Senior QA Specialist may be asked to participate in regulatory inspections, client audits and internal audits.

The role

• Assist the Quality Assurance Manager in ensuring compliance with all Quality Management Systems and Regulatory Agency requirements (e.g., FDA, EMA, MHRA, etc..) for the site.
• Conduct investigations of OOS, Deviations, Change Control Management, and CAPAs.
• Work cross-functionally with other departments on Analytical Quality Assurance activities such as reviewing various documents, protocols, qualifications and/or reports related to Quality Management Systems.
• Develop and/or review and/or approve quality standards, policies, and procedures for all functions and departments involved in cGMP activities.
• Support all the Regulatory Agency inspections at the site and the preparation of CAPAs and monitor the completion of assigned tasks.
• Lead and drive the GMP activities, work with manufacturing Managers and Supervisors to complete the deviation investigations on time.
• Responsible driving the established Quality Metrics.
• Review and approve master batch records as and when required.
• Manage all the customer audits at the site, lead the preparation of CAPAs, and monitor their completion providing updates to customers and management.
• Report serious or repeated observations or serious compliance gaps to quality management.
• Manage the Internal Audit program including coordination of auditors within the QA department.
• Interact with Quality networks to share information related to quality expectation, inspections, audits, facilitating harmonisation of quality systems.

Requirements

• Minimum Bachelor of Science degree in Chemistry or a related field.
• QA, RA or Compliance experience in pharmaceutical industry (preferred in APIs) at USFDA regulated facilities.
• Broad knowledge of cGMP, FDA and international regulations (e.g., 21 CFR 11, 210, 211, 820, EU GMP, ICH Q7), Quality Systems for active pharmaceutical ingredients (APIs), and familiarity with guidelines (e.g., FDA, ICH).
• Knowledge of pharmaceutical processes.
• USFDA inspection experiences (participating or leading).
• Excellent communication and organisational skills, as well as negotiation, influencing, and collaboration skills, and demonstrated ability to work cross functionally across internal stakeholders.
• Proficient in building consensus, negotiating and escalating issues.
• Good understanding of the importance and use of quality metrics.