QA Specialist I **$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. • 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!