Huxley, IA, 50124, USA
13 days ago
Regulatory Quality Assurance Manager
Job Title: Regulatory Quality Assurance SpecialistJob Description We are seeking a dedicated Regulatory Quality Assurance Specialist to ensure our products meet the highest quality standards and comply with regulatory requirements. The ideal candidate will oversee batch records, manage standard operating procedures, and ensure compliance with established protocols before product release. This role involves collaborating with cross-functional teams, conducting audits, and implementing corrective and preventive actions. Responsibilities + Oversee batch records and ensure timely completion + Review all products to meet quality standards in compliance with regulatory requirements + Manage and oversee standard operating procedures (SOPs) + Ensure compliance with established protocols and quality standards before product release + Develop, review, and update SOPs and quality documents + Conduct regular audits of processes and documentation + Collaborate with cross-functional teams to address quality-related concerns + Implement corrective and preventive actions (CAPA) + Train and mentor staff on quality assurance processes + Prepare for inspections and audits + Maintain accurate and detailed records and generate reports Essential Skills + Attention to detail + Excellent interpersonal and communication skills + Proficient in quality assurance practices, batch record management, and SOP development + Knowledge of regulatory quality standards and compliance + Experience in conducting audits and documentation review Additional Skills & Qualifications + Bachelor's degree in Chemistry, Chemical Engineering, or related field + Relevant certifications in quality assurance + Minimum of 2 years of experience in quality assurance within the chemical manufacturing industry + Proficient in quality management systems and software tools Work Environment This role is primarily office-based with occasional visits to the production floor. The facility offers a pleasant working environment with a minty aroma throughout. Employees enjoy great benefits, including 8 paid holidays and negotiable PTO. The work hours are flexible, typically 8-9 hours from Monday to Thursday, with Fridays being more relaxed as most employees leave by noon. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: + Hiring diverse talent + Maintaining an inclusive environment through persistent self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
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