Sr. Quality Control Specialist
22 days ago
West Valley City
Job Description Benefits Offered: • Medical, • Dental, • Vision, • 401K with company match, • PTO, • 11 Paid Holidays Biovation Labs is seeking a Senior Quality Control Specialist to join our team. The Senior QC Specialist provides advanced support for quality operations under the guidance of the QC Manager. This role leads key operational initiatives, including environmental monitoring, SOP updates, specification support, inspections, and stability program management. The Senior QC Specialist ensures compliance with cGMP, supports OOS investigations, and manages critical documentation and QMS activities, including ingredient data and raw material specifications. This role also contributes to continuous improvement initiatives. Job Duties & Responsibilities : Continuos Improvement & Quality Initiatives • Support continuous improvement initiatives to enhance operational efficiency and product quality., • Monitor QC metrics and trends and support process improvement initiatives., • Oversee the design, implementation, and maintenance of an effective Environmental Monitoring Plan (EMP), • Conduct swabbing and sampling activities at defined frequencies, analyze results, and implement appropriate containment measures for affected areas., • Participate in and support CAPA, OOS, NCR, and deviation investigations under the QC Manager’s direction., • Assist with investigation closure activities, ensuring appropriate documentation and follow-up actions., • Conduct inspections of finished goods, in-process materials, and components to ensure compliance with specifications., • Verify product weights, labeling, and documentation accuracy., • Upload and maintain ingredient information, raw material data, and specifications within the QMS., • Ensure accurate and current document control for specifications, test methosds, and supporting data., • Support the review and release of component materials and finished goods., • Administer the stability program, including sample tracking, test scheduling, data recording, and documentation and results., • Participate in internal audits and regulatory inspections as needed., • Maintain a strong working knowledge of evolving regulatory and company requirements., • High School Diploma or GED; additional education preferred., • Significant experience in QC or regulated manufacturing, with exposure to investigations, audits, and CAPA., • Strong analytical, problem-solving, and decision-making skills., • Effective leadership, mentoring, and cross-functional collaboration., • Proficiency in Microsoft Office and regulatory documentation., • Ability to lift 25 lbs and perform standard physical duties., • Excellent written and verbal communication skills