QA Specialist I

Job Description

Job Description

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

• BA/BS degree in life or physical sciences preferred (e.g., Pharmaceutical Sciences, Chemistry, Analytical or other relevant disciplines).
• 7+ years of experience in Quality, Compliance and/or Regulatory Affairs preferred. 
• 7+ years of experience in a FDA and cGMP environment preferred. 
• Experience in a cGMP pharmaceutical environment preferred.
• In-depth understanding of FDA 21 CFR regulations, ICH Guidelines, EU and Canadian GMPs.
• Proficient in Microsoft Word, Excel, SharePoint, and Acrobat Professional.
• Outstanding written, verbal, and interpersonal communication skills required.
• Strong attention to detail.
• Ability to work independently and in a team.
• Ability to establish and maintain effective working relationships with team members, co-workers, and/or clients.

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!