Manages the plant QC Inspections Staff. Responsible for implementation and maintenance of related Good Manufacturing Practices (GMP), sampling plans, staffing and the QC Inspections Program for the IF Plant, K-Pak Warehouse, Rexburg and the Powder Plant.
Essential duties, responsibilities, and qualifications of the job can be performed with or without reasonable accommodation and without posing a direct threat to him/herself or others.
Duties and Responsibilities
- Conducts or coordinates internal audits of plants for compliance to GMP.
- Acts as liaison with FDA and other regulatory agencies during routine inspections of Inspection Systems.
- Develops documentation and trains written procedures for the plant QC Inspection Programs.
- Maintains the QC testing laboratories where applicable in accordance with GMPs.
- Coordinates and trains the sampling of ingredients for conformance to specifications.
- Coordinates and trains the inspection of packaging components and outside manufactured products for conformance to specifications.
- Coordinates the sample/ingredient retain program.
- Coordinates the recertification and salvage program.
- Works with Purchasing/Forecasting to assure proper flow and prioritization of items through inspections.
- Maintains physical standards and sampling sheets for all inspected materials.
- Interacts with plant management to assure GMP awareness and compliance.
Supervision of Others
- Performs other duties as assigned or needed.
- Destruction or storage of outdated documents according to guidelines.
- Provides direct supervision to QA inspection staff and technicians by performing such duties as determining employment status (i.e. hiring, terminating, promotions, issuing warnings, etc.), interviewing applicants, counseling, training, scheduling, resolving conflicts, coordinating with other departments, conducting employee meetings, recommending wage increases, etc.
- Bachelor’s degree or 5+ years industry Quality Assurance supervisory experience.
- A working knowledge of Federal Regulations regarding the manufacturing and distribution of drug products.
- Minimum 3 years experience in pharmaceutical (or medical device) Quality Assurance, including experience in component and finished product inspection.
- Excellent verbal and presentation skills.
- Ability to organize and coordinate projects.
- Ability to manage a department budget.
- Ability to perform multiple tasks in a fast paced setting.
- Ability to perform duties with efficiency and accuracy.
- Statistical and data analysis skills.
- Computer word processing, spreadsheet, and database skills.
Melaleuca - 9 months ago
Melaleuca grows its sales from the ground up. Deriving its name from the tea tree (Melaleuca alternifolia), the company is a leading manufac...