What are the responsibilities and job description for the Quality Assurance Specialist position at Empire?
Quality Assurance Specialist
Pay Range: $60-65k
Location: Orangeburg, NY
Schedule: M-F 7:30am to 4pm
Summary of Position:
Determines disposition of final product and ensures compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and PBA Standard Requirement Documents. Works with the Quality Team by helping to perform tasks for ongoing projects: coordination, organization of files, distribution of tasks and project status tracking. Consults with Quality Management to discuss effective plans for resolving major quality, production, and efficiency problems.
Job duties
- Maintain technical files for product approval and ensure GMP compliance for raw materials, in-process, finished products, packaging, and labeling.
- Review and approve batch records and documents; assign QA release status and disposition to finished products.
- Analyze test data and generate metrics to improve batch record review processes; support continuous improvement and training efforts.
- Review and approve sops, Specifications, Deviations, Change Controls, OOS/oots, and Test Methods; ensure compliance with industry standards.
- Verify laboratory protocols and reports for cgmp/GLP compliance; maintain QA database and monitor testing procedures.
- Prepare reports analyzing data from customer complaints/adverse events; resolve issues and escalate as needed.
- Update and maintain Quality Management System documentation to reflect regulatory changes.
- Perform additional QA tasks, including Environmental Monitoring and Vendor Qualifications, as directed by Supervisor or Manager.
Requirements:
- BS in Engineering is preferred
- Experience with CFR Regulations, cGMP Regulations and FDA Environment (Food or Pharmaceuticals) preferred
- Must have good English written and verbal communication skills
- Detail oriented. Great tracking skills
What is in it for you?
- Great company environment
- 136 hours PTO, 9 paid holidays, 1 floating holiday, and birthday off.
- "Fun squad" plans 5 events/year (food trucks, sports, volunteering, trivia nights, etc.).
- Holiday and summer parties.
- 2 summer Fridays (½ day company-paid).
- Excellent benefits with 4% 401k company match.
Apply now!
Job Type: Full-time
Pay: $60,000.00 - $65,000.00 per year
Application Question(s):
- Please confirm your email:
Experience:
- FDA regulations: 2 years (Required)
Ability to Commute:
- Orangeburg, NY 10962 (Required)
Work Location: In person
Salary : $60,000 - $65,000
