QA Auditor

Job Description

We are seeking a dedicated QA Auditor to join our team. The role involves performing in-house line audits of pharmaceutical filling and packaging operations, ensuring compliance with standard operating procedures. The QA Auditor will conduct line clearances, in-process inspections, and end-item inspections, and will be responsible for reviewing and applying specifications for acceptance of packaging components, raw materials, and finished products. Additionally, the role requires generating, reviewing, and issuing batch production records, releasing materials and components for production use, organizing and distributing printed materials to production, and monitoring and interpreting charts and gauges. Successful candidates will receive onsite training and must possess strong knowledge of contemporary cGMP practices and procedures.

Responsibilities

• Perform in-house line audits of pharmaceutical filling and packaging operations.
• Review manufacturing activities and documentation for compliance with SOPs.
• Conduct line clearances, in-process, and end-item inspections.
• Review and apply specifications for acceptance of incoming packaging components, raw materials, and finished products.
• Generate, review, and issue batch production records.
• Release materials and components for use in production.
• Organize and issue printed materials to production.
• Monitor and interpret charts and gauges.
• Review, issue, and archive log books.

Essential Skills

• Quality assurance and audit experience.
• Knowledge of internal audits, compliance, and inspections.
• Proficient use of micrometers, calipers, and quality inspection tools.
• Strong written and oral communication skills.
• Technical writing skills.

Additional Skills & Qualifications

• Associates degree in Science, or equivalent is required.
• Bachelor's degree in Science, or equivalent is preferred.
• 1-4 years' experience in Quality Assurance or Manufacturing, preferably in an FDA regulated environment.
• Working knowledge of cGMPs is preferred.
• Ability to manage time effectively and work with minimal supervision.
• Knowledge of Good Documentation Practices.
• Ability to review large executed production batch records and identify errors.
• Attention to detail and ability to coordinate various activities simultaneously.
• Professional communication skills.
• Ability to maintain confidentiality and solve practical problems.

Work Environment

The work environment includes clean room, manufacturing, and laboratory settings. The typical schedule is 4, 10-hour days during the first shift, which runs from 6:00 AM to 4:30 PM. Flexibility is required for various days of the week, and a 5-day schedule may be indicated. Overtime rates apply for hours over 40 per week. Alternative work hours or schedules may be required at the discretion of management.

Pay and Benefits

The pay range for this position is $43680.00 - $52000.00/yr.

Eligibility requirements apply to some benefits and may depend on your job

classification and length of employment. Benefits are subject to change and may be

subject to specific elections, plan, or program terms. If eligible, the benefits

available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Syracuse,NY.

Application Deadline

This position is anticipated to close on Jun 24, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.