Quality Assurance Supervisor
4 days ago
Omaha
Job Description Position Description The Quality Assurance Supervisor is responsible for leading, coordinating, and overseeing Quality Assurance (QA) activities to ensure the Company’s Quality Systems comply with applicable GMP, FDA, and internal requirements. This role provides direct supervision to Quality Assurance Specialists to ensure effective execution of QA processes, supports regulatory inspections, and drives continuous quality improvement across the organization. Responsibilities • Manage, develop, and maintain the Quality Management Systems for all sites in Cohere Beauty, • Manage the Change Control process for all sites, ensuring effective change control processes are followed and documented, • Work with the Customer Coordinators (CCs) and Customer Success Managers (CSMs) to update and ensure accurate BOMs and Specifications for all products, • Provide support and oversight for Nonconformances, Customer Complaints, and CAPAs to ensure root cause analysis and effective resolution, • Review trending reports, quality metrics, and key performance indicators to identify risks and improvement opportunities., • Ensure compliance with Good Manufacturing Practices (GMP), FDA regulations, and applicable standards., • Review and approve SOPs, policies, protocols, reports, and training materials., • Support activities during inspections (FDA, ISO, Customers, etc.), • Ensure documentation systems (audit records, training records, deviation reports, CAPAs) are accurate, complete, and inspection-ready., • Perform or oversee gap analyses against regulatory and industry standards., • Recommend and implement improvements to quality processes, systems, and programs., • Facilitate quality-related meetings and cross-functional discussions., • Communicate quality expectations, regulatory updates, and compliance trends to leadership and staff., • Provide clear guidance and interpretation of regulatory requirements to internal stakeholders., • Directly supervise, coach, and mentor Quality Assurance Specialists, • Assign, prioritize, and review QA work to ensure accuracy, timeliness, and compliance., • Provide onboarding, training, and ongoing performance feedback to QA staff., • Conduct performance evaluations and support professional development plans., • Serve as an escalation point for quality issues, compliance concerns, and decision-making., • Act as the primary point of contact between QA staff and management., • Perform other duties as assigned Minimum Education & Experience • Bachelor’s degree, preferably in Chemistry or in physical or biological science., • Minimum 5 years’ experience in a Food and Drug Administration (FDA) or other regulated manufacturing environment., • Minimum 3 years of progressive experience in Quality Assurance. Knowledge, Skills & Abilities • Demonstrable strong written and verbal communication skills., • Excellent organizational skills., • Proven record of excellent documentation skills., • Strong problem-solving skills., • Work well under pressure and are able to prioritize workloads., • Ability to perform risk assessment., • Experience fostering teamwork to get results., • Well organized and multi-task oriented., • Ability to work independently on multiple projects., • Ability to read, write, and speak English competently., • Ability to maintain reliable and predictable attendance. Preferred Knowledge, Certifications, Skills & Abilities • Worked in pharmaceutical or cosmetic mfg. environment., • Project management and technical software skills (Excel, Access, etc.) required., • Experience with transitioning to an eQMS Travel & Working Conditions • Primarily office environment – climate-controlled., • Periodic visits to:, • Warehouse environment – some temperature extremes, dust, and noise., • Manufacturing environment - some temperature extremes, dust, noise, and wet., • Potential exposure to hazardous chemicals., • Requires use of PPE such as safety glasses, hairnets, or gloves, • No annual travel requirements with this position. The specific statements shown in each section of this description are not intended to be all-inclusive. They represent typical elements and criteria considered necessary to perform the job successfully. Cohere Beauty recognizes that an individual with a disability may require accommodation to enable him/her to successfully perform a job function. Consideration will be given to reasonable accommodation.