LOCATION: Madison, WI area
FLSA Status: Non-Exempt
The Quality Assurance Lead provides technical and professional assistance to various functions within the organization to support the achievement of quality, safety, sales and production goals and provides ongoing maintenance and continuous improvement of the Quality Management System. This position is in Madison and reports to the site Quality Manager.
To perform this job successfully, an individual must be able to perform each essential job duty. Essential job functions and duties include, but are not limited to:
- Participate in or lead facility quality management systems, such as CAPA, deviations, qualifications, validations, and audits, as well as food safety preventive controls per FSMA requirements.
- Manage the customer complaint process, including leading investigations and follow up on resolution.
- Assists with writing Standard Operating Procedures, Standardized Work Instructions, and forms.
- Coordinate supplier quality management activities, including audits and qualifications.
- Identify, prioritize, communicate, and resolve supplier quality issues.
- Provide trending analysis on supplier quality and performance metrics.
- Assist with new process design and validation to assure effective control procedures are established.
- Perform internal quality/process audits to assess compliance to regulations and the internal quality management system.
- Collect and trend off-line data for quality and process performance data.
- Assist in the development of process monitoring systems in accordance with food safety plans and to reduce process variation to reduce/eliminate causes of defects.
- Work with all functional areas to resolve quality issues and assure compliance with regulations, company standards, and customer requirements.
- Help facilitate continuous improvement and learning across all functional areas.
- Overseeing the batch record issuance process according to the production schedule.
- Maintains and updates quality-related spreadsheets and trackers.
- Other duties as assigned.
The appropriate knowledge, skills, and abilities required for this position are achievable through the following combination of education, work experience and training:
- Associates degree in a related field; or 4 years related experience and/or training in manufacturing environment; or equivalent combination of education and experience.
- Quality Assurance experience with a focus on quality systems in an FDA-regulated manufacturing environment, preferably in dietary supplements or pharmaceuticals.
- Strong working knowledge in GMP in FDA regulated industry; preferably food or dietary supplement manufacturing.
- Fundamental understanding of quality systems and the development, documentation, implementation, and improvement of the quality management system with respect to standards and regulations.
- ASQ Quality Auditor certification preferred.
- Demonstrated skill in audit planning, techniques, execution, reporting results and follow-up.
- Proficient with problem-solving and quality improvement tools and techniques.
- Able to plan, control, and assure product and process quality in accordance with quality principles.
- Excellent communication, organizational, planning, problem-solving, and follow-up skills.
- Ability to work effectively as a team player in a diverse work group.
- Self-starter, motivated and ability to work unsupervised.
- Strong written and verbal communication skills required.
- Enthusiastic, cooperative, and positive behavior/attitude.
- Strong computer skills with proven proficiency in Microsoft Word, Excel, Power Point, and Visio. Experience with EQMS and ERP systems a plus.
- Occasional travel is required.
To apply, please send your resume to email@example.com