Senior Quality Control Specialist
2 weeks ago
We are seeking a highly skilled Senior Quality Control Specialist to join our team at Yoh, a Day & Zimmermann company. As a key member of our quality assurance team, you will be responsible for ensuring the highest standards of quality in our products.
Key Responsibilities:
- Develop, implement, and maintain quality control systems and measures
- Inspect and test raw materials, fragrances, in-process, and customer-supplied bulk against specifications to ensure quality standards are met
- Establish priorities to ensure timely job completion
- Issue adjustments to in-process bulk as necessary
- Complete inspection forms for finished bulk/intermediate and/or raw materials and fragrances
- Update status of raw materials and/or bulk/intermediate in the ERP system
- Communicate quality control information to relevant organizational departments, outside vendors, or contractors
- Produce and communicate reports regarding nonconformance of products
- Assist in investigations related to nonconformance or OOS, customer complaints
- Provide department-related data, trends, etc. for management review
- Resolve production and manufacturing problems to minimize cost and delay
- Maintain raw material retains for the department
- Maintain all quality systems logs related to the department
- Monitor performance of QC systems to ensure effectiveness, efficiency, and compliance to company SOPs and regulatory requirements
- Assist in updating or writing department-related SOPs and work instructions or other department-related documents
- Review statistical studies, technological advances, or regulatory standards and trends to stay abreast of issues in the field of quality control
- Identify and implement training needs for the production team to meet quality standards
- Instruct staff in QC and analytical procedures
- Assist in raw materials and bulk/intermediate cycle counts and full inventories
- Consistently demonstrates excellent interpersonal skills and professionalism to company management, all levels of staff, and vendors and outside agencies
Qualifications:
- Bachelor's degree in science (chemistry, pharmacy, or biology) or equivalent work experience
- 5+ years quality control-related experience in a cGMP OTC manufacturing environment
- Knowledge of drug cGMPs, SOPs, and regulatory guidelines, including FDA requirements
- Proficient use of Microsoft Office products, including Word, Excel, Outlook, and PowerPoint
- Experience using common laboratory equipment, such as pH meters, refractive index, pycnometers, Brookfield viscometers, color matching, scales, and lab mixers
- Must be able to clearly and concisely communicate verbally and in writing in English
- Ability to speak and understand Spanish is a plus
- Must be able to analyze and present quantitative data
- Able to accurately compute basic mathematical equations, such as addition, subtraction, division, multiplication, and percentages
- Must be able to analyze and interpret data relating to various projects and resolve issues and problems that arise
Physical Demands and Work Environment:
- Must have good visual/organoleptic alertness
- Must be able to sit for up to eight hours per day, lift and carry up to 20 lbs with or without assistance, reach above shoulder height, bend, stoop, and crawl to retrieve items from under a desk or floor-level cabinet or drawer; push and pull, use a computer keyboard throughout the workday, stand while filing or performing other essential responsibilities
- Exposure to standard chemicals used in an office environment is expected and includes but is not limited to toner, glue, and liquid paper or white out
- Additionally, the incumbent will be exposed to chemicals used in the manufacturing process of nutritional supplements, cosmetics, and prescription drugs
- Must have reliable transportation and valid driver's license and be able to drive to appointments
- Must maintain current, in-force vehicle insurance
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