What are the responsibilities and job description for the Quality Associate II position at Premier Magnesia?
COMPANY BACKGROUND:
Premier Magnesia, LLC is a privately held company and a global market leader in magnesia-based products and solutions for dozens of applications ranging from agricultural to industrial and environmental markets. We are one of the world's principal manufacturers and suppliers of high purity calcined magnesium oxide and magnesium hydroxide products. For over 50 years, the Company and its predecessors have owned and operated a magnesia mine and processing plant located in Gabbs, Nevada that will continue to offer the only domestically mined source of magnesia ore in the United States well into the future.
POSITION SUMMARY:
The primary responsibility of this position is to provide Quality support to Manufacturing ensuring compliance with all applicable regulatory mandates and customer specific requirements. Responsible for the proactive participation in the efforts to prevent, detect, report, correct or cause to be corrected the production of non-conforming material or product through routine conduct of audits/inspections at all stages of production. Enforces and educates employees on Good Manufacturing Practices and Good Documentation Practices.
Essential Functions:
- Conduct various Quality audits (SCR, Trailer Inspections, Process Audits), identify issues, and maintain cGMP compliant documentation of such activities.
- Work closely with Production, and Quality Manager to correct issues found prior to the shipments of loads.
- Work closely with Production to correct cGMP-GDP issues found in Shift-to-Shift Batch Record Reporting prior to final Batch Review.
- Ensure completion of Annual Weight Calibration for Quality specific weights.
- Inspection of in-process 50lb bags and 2000lb Super Sacks.
- Communicating issues found in Production as they arise.
- Customer Specific Testing (Bulk Density)
- Liquid Load Testing (In-Process Testing)
- In-Process Testing & Data Reporting (Bulk Density, Mud pH, etc.)
- Maintain Compliance and Issues Found in reporting Spreadsheets
- Maintain Metal Contamination Prevention Program
- Ensure completion of Annual Compact Force Gauge (Magnet Strength Tester) Calibration
- Conduct Semi-Annual Magnet Strength Tests of necessary equipment.
- Conduct non-conforming product audits (Collect Data, Write Reports, and Communicate to necessary individuals)
- Maintain Temperature and Humidity Data
- Assist with preparation for Regulatory Agencies, 3rd Party Certifications, and Customer Audits
Perform other duties, as needed, based on evolution of the company and the requirements of the department/position.
Special Knowledge, Skills, and Training:
- Fundamental understanding of cGMP and Safety regulations.
- Ability to influence people; must be able to drive results via influence rather than direct authority.
- Ability to repeatedly lift/turn 50lb bags.
- Ability to stand for long periods of time while conducting audits, inspections, and testing.
- Ability to work overtime and one day per weekend as production and shipping schedule demands.
- Possess oral and written communication skills, strong interpersonal skills, strong organizational abilities, and able to work in a team environment.
- Must have strong personal time management skills with ability to work with minimal supervision and must have Multi-Task capabilities.
- Intermediate computer skills (Microsoft Word and Excel).
- Previous Quality Auditing experience a plus.
- Background in medical, food, or pharmaceutical manufacturing a plus.
Education (minimum requirements/equivalent):
- High school diploma required. Degree in scientific or technical field preferred.
- Two years’ work experience in Quality Assurance/Quality Control and/or in a regulated Manufacturing environment needed. Further experience may be considered in lieu of education.
- Certification as a CQA is highly desirable.
