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QA Specialist I
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 **$2,000 Sign-On Bonus!**
 1st Shift: 8:00am – 5:00pm, Mon - Fri
Â
 **$2,000 Sign-On Bonus!**
 1st Shift: 8:00am – 5:00pm, Mon - Fri
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.Â
- 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.Â
- 7+ years of experience in a FDA and cGMP environment preferred.Â
- 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.Â
- Sign-On Bonus!
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