QA Specialist I

Position Overview

The primary role of the QA Specialist I position is supporting validation activities, product release, Investigations, Deviations, CAPA programs, and a variety of quality system activities.

Essential Job Functions

• Provide compliance/regulatory review of documents (SOPs, protocols, and reports), as necessary.
• Support the Investigations, Deviations and CAPA programs.
• Assist in preparing Annual Drug Product Reviews.
• Participate in Quality Systems improvement projects.
• Support responses to questions and/or concerns from regulatory agencies within the timeframes specified.
• Participate in validation activities.
• Assist in preparing required regulatory/compliance statements.
• Maintains compliance with all company policies, plans, and procedures, including safety, security, and regulatory.
• Assists with Quality and Supplier audits, as needed.
• Employees at Coating Place work with and/or are familiar with the GMP requirements for Food, Dietary Supplements, Pharmaceuticals, or other elements of each. 
• Depending on the position, the employee will be aware of Halal and/or Kosher requirements.
• Other duties as assigned.

Education/Skills/Knowledge Required

Competitive Benefits:

• Friendly work environment.
• Medical, Dental, Vision, Life, AD&D, and Disability Insurance.
• Pre-tax 401(k) and after-tax Roth 401(k) contribution options with company matching up to 5%.
• Generous Paid-time Off - Accrue up to 17 days of PTO within the 1st year.
• Tuition Reimbursement Program. 
• Sign-On Bonus!