Lansdale, PA, United States
Root Cause Analysis
8am – 5pm | Mon – Fri
$80,000 - $90,000
This role is responsible for the management of quality control processes, procedures and the people involved at our company. The Quality Manager is also responsible for maintaining the ISO 9001 system aspects which involves the quality control function. The scope of the quality control processes includes the supply of raw materials, manufacturing process controls the assessment & release of finished goods relative to agreed-upon specifications.
Day to Day:
➢ Manages all activities of the quality control laboratories including the following:
Manages safe behaviors and procedures in the lab.
Appropriate environmental controls and handling of laboratory chemicals.
Supervises quality control technicians, including training, productivity and performance assessment.
Maintain all quality testing and analytical procedures according to good laboratory practices and standards.
Manages reliability, maintenance and accuracy of testing equipment.
Assures adequate supplies and materials for effective lab operations.
Periodically develops analytical methods.
➢ Supervises corrective action processes for following up on customer feedback:
Collects, monitors and communicates customer feedback information
Ensures investigations for root cause analysis and corrective actions are clearly assigned and completed.
Monitors and reports on feedback provided to customer and closure of investigation.
➢ Assists in supporting manufacturing processes and assists with process troubleshooting as required with Plant Engineer and Production Supervisors.
Maintenance of approved list of raw materials in the controlled bill of materials.
Prepares batch sheets with approved raw materials consistent with controlled formulations and recipes.
Controls introduction of rework materials in batch sheets.
➢ Supports development of process controls, operating procedures and general best practices in production operations.
Reviews and approves operating procedures for inclusion of adequate instructions and process controls consistent with finished goods quality controls.
Ensures an adequate management of change process – effective reviews and controls when changes are proposed before implementation.
Reviews and assesses where operators are performing in process control checks for accuracy and effectiveness.
Knowledge, Skills, and Abilities:
Quality control processes are effective and efficient in meeting agreed-upon customer specifications.
Customer feedback regarding product quality is effectively captured, acted on and communicated for continuous improvement.
Raw material and manufacturing controls to support manufacturing meeting requirements efficiently and effectively.
Strong interpersonal skills.
High degree of attention to detail.
Strong communication and presentation skills.
Ability to work independently with minimal supervision.
Functional with Microsoft Office Suite of products.
Primarily day shift position but available as needed for troubleshooting
Physical demands – the physical demands listed here are representative of those that must be met by an employee to successfully perform the essential functions of the job. The employee must occasionally lift and or move 50 pounds. The employee must be able to climb stairs and work from heights.
Education, Training, Requirements:
Bachelors of Science Degree in Chemistry or Chemical Engineering.
Basic laboratory analytical techniques including Gas Chromatography, Titration, and various melt point and viscosity tests.
cGMP experience desired but not required.
5 to 7 years of experience working/managing a lab.
Job Type: Full-time
Salary: $80,000.00 to $90,000.00 /year