A Regulatory Affairs Specialist maintains specialized knowledge of state and federal government regulations that affect an employer. Interprets regulations and implements procedures that bring an employer into compliance with regulations; may audit internal compliance with regulations.
Verona, WI Job Details Full-time 16 hours ago Benefits AD&D insurance Disability insurance Health insurance Dental insurance Tuition reimbursement Paid time off Vision insurance 401(k) matching Qualifications Microsoft Excel Drug regulation Word embeddings Employee relationship building GMP ICH guidelines SharePoint Productivity software Stakeholder relationship building FDA regulations Full Job Description 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!
