Job Description
Job DescriptionQA AuditorJob Description
We are seeking a motivated and detail-oriented QA Auditor to join our team. In this role, you will perform essential line audits of pharmaceutical filling and packaging operations and ensure compliance with SOPs. You will also conduct line clearances, in-process, and end-item inspections, and review specifications for acceptance of packaging components, raw materials, and finished products. Additionally, you will be responsible for generating, reviewing, and issuing batch production records, releasing materials for production, and organizing printed materials for production. The position requires a strong knowledge of contemporary cGMP practices and procedures, as well as excellent written and oral communication skills.
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.
- 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 auditing skills.
- Experience with internal audits, compliance, and inspections.
- Proficiency in using micrometers, calipers, and light inspection units.
- Knowledge of Good Documentation Practices.
- Ability to review large executed production batch records thoroughly.
- Strong attention to detail and ability to coordinate activities simultaneously.
- Effective time management skills.
- Excellent written and oral communication skills.
Additional Skills & Qualifications
- Associates degree in Science or equivalent is required.
- Bachelors 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.
- Technical writing skills are a plus.
Work Environment
The work environment includes clean rooms, manufacturing facilities, and labs. The typical first shift schedule consists of four 10-hour days, with standard work hours from 6:00 AM to 4:30 PM. Flexibility in availability for various days of the week and a five-day schedule may be required. Overtime rates apply for hours worked 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.
Company Benefits
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 Aug 4, 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.