QA Auditor

Actalent; New York (NY); On-site; USD 55,000 - 75,000; Full time

Job summary

Actalent is seeking a QA Auditor in New York to perform in-house line audits of pharmaceutical filling and packaging operations, ensuring compliance with SOPs and regulatory standards. This role reviews production activities and batch records for adherence to SOPs, overseeing material release and documentation control.

Onsite training is provided, and the position suits motivated individuals with strong interest in quality assurance and cGMP practices.

Qualifications

• 1–4 years of experience in Quality Assurance or Manufacturing, preferably in an FDA-regulated environment.
• Associates degree in Science or equivalent is required.
• Working knowledge of contemporary cGMP practices and procedures is preferred.
• Knowledge of Good Documentation Practices.

Responsibilities

• Perform in-house line audits of pharmaceutical filling and packaging operations to verify compliance with SOPs and quality standards.
• Review manufacturing activities and documentation for adherence to SOPs and applicable regulations.
• Conduct line clearances to ensure production lines are properly prepared and free of previous product and materials before new operations begin.
• Perform in-process inspections to monitor product quality during manufacturing.
• Conduct end-item inspections to confirm that finished products meet specifications and quality requirements.

Skills

Quality Assurance

FDA-regulated

Documentation

Attention to detail

Education

Associates degree in Science

Bachelor's degree preferred

Tools

Calipers

Micrometers

Job description

Job Description

Job Description

Job Title: QA Auditor

Job Description

The QA Auditor performs in-house line audits of pharmaceutical filling and packaging operations to ensure products and processes comply with established procedures and regulatory standards. This role reviews manufacturing activities and documentation for adherence to standard operating procedures (SOPs), conducts inspections at multiple stages of production, and manages batch records and materials release. Onsite training is provided, and the position is ideal for motivated self-starters with a strong interest in quality assurance and contemporary cGMP practices.

Responsibilities

• Perform in-house line audits of pharmaceutical filling and packaging operations to verify compliance with SOPs and quality standards.


• Review manufacturing activities and documentation for adherence to SOPs and applicable regulations.


• Conduct line clearances to ensure production lines are properly prepared and free of previous product and materials before new operations begin.


• Perform in-process inspections to monitor product quality during manufacturing.


• Conduct end-item inspections to confirm that finished products meet specifications and quality requirements.


• Review and apply specifications for acceptance of incoming packaging components, raw materials, and finished products.


• Generate, review, and issue batch production records in accordance with Good Documentation Practices.


• Release materials and components for use in production once quality and specification criteria are met.


• Organize and issue printed materials to production areas, ensuring accuracy and proper control.


• Monitor and interpret charts, gauges, and other measurement tools to assess process performance and product quality.


• Review, issue, and archive log books and related documentation in a controlled and compliant manner.


• Thoroughly review large executed production batch records and identify errors that require correction.


• Coordinate various quality assurance activities simultaneously while maintaining attention to detail.


• Communicate with coworkers and management in a courteous and professional manner to support quality and production objectives.


• Maintain confidentiality of proprietary and sensitive information.


• Apply practical problem-solving skills to address a variety of concrete variables in situations with limited standardization.


• Effectively manage time and prioritize tasks to meet production and audit schedules, working with minimal supervision once trained.

Essential Skills

• 1–4 years of experience in Quality Assurance or Manufacturing, preferably in an FDA-regulated environment.


• Associates degree in Science or equivalent is required.


• Working knowledge of contemporary cGMP practices and procedures is preferred.


• Knowledge of Good Documentation Practices.


• Ability to use micrometers, calipers, and light inspection units for precise measurements and inspections.


• Strong attention to detail and accuracy in reviewing documentation and product quality.


• Ability to thoroughly review large executed production batch records and identify errors.


• Ability to manage time effectively and coordinate multiple activities simultaneously.


• Ability to work with minimal supervision after training is completed.


• Strong written and oral communication skills for documentation and interaction with team members.


• Ability to maintain confidentiality of sensitive information.


• Ability to solve practical problems and work with a variety of concrete variables in situations with limited standardization.

Additional Skills & Qualifications

• Bachelors degree in Science or equivalent is preferred.


• Experience in Quality Assurance or Manufacturing in an FDA-regulated pharmaceutical environment is preferred.


• Technical writing skills are a plus.


• Knowledge of internal auditing and compliance practices related to quality assurance.


• Experience with quality control and quality inspection activities.


• Ability to conduct audits and inspections using measurement tools such as micrometers and calipers.


• Strong interpersonal skills to communicate effectively with coworkers and management in a professional manner.


• Self-motivated, highly driven work style with the ability to act as a self-starter.


• Ability to adapt to different work schedules and changing priorities as needed by production and quality operations.

Work Environment

This role is based in a clean room, manufacturing, and laboratory environment focused on pharmaceutical filling and packaging operations. The typical first-shift schedule c