Description

Summary:

Prioritize daily sample testing and perform a variety of laboratory tests on raw materials, in-process and finished batches. Review compounding and laboratory records for accuracy and completeness. Investigate customer complaints, OOS/OOT results and implement any corrective action as determined by QC supervision.

Essential Duties and Responsibilities:

• Perform laboratory analysis on incoming raw materials, in-process samples, and finished products per established procedures, including wet chemistry.
• Perform general housekeeping duties.
• Sample raw materials per approved procedures.
• Coordinate information flow within the laboratory and to internal customers.
• Access, input, and retrieve information from the QC computer systems.
• Disposition of raw materials, process samples and finished products for use or sale.
• Be thoroughly versed in GMP regulations and ensure that all laboratory documentation meets standards for completeness and accuracy.
• Demonstrate a complete understanding of safe procedures for processing, analyzing, and storage of hazardous and/or flammable products and raw materials in accordance with local, state, and federal guidelines.
• Document deviations in performance not anticipated or indicated in test procedures.
• Be or become thoroughly familiar with QC and manufacturing process and work flow, QC retain program and documentation procedures.
• Work with minimal supervision, re-prioritizing work schedules quickly.
• Become familiar and assist with OOS/OOT and Customer complaint investigations.
• Become familiar and assist with Annual/New Supplier Validations protocol, sample transfer and testing process.
• Become familiar and assist with SOP creation, review and revision activities.
• Become familiar and assist with Stability protocol and testing processes.
• Become familiar and assist with supplies/services ordering process.
• Become familiar and assist with contract manufacturing protocol and work flow.
• Must be able to perform any routine task in the laboratory in an efficient manner.
• Must provide timely, accurate information to production personnel.
• Participate in meetings as required.
• Complete training assignments as required.
• All other duties as assigned.

Supervisory Responsibilities:

N/A

Education Requirements:

Associates degree in quality or chemistry related programs is desired or a minimum 1 year QC or QA experience in a like industry environment.

Experience Requirements:

Requires a minimum of 1 years Vi-Jon specific QC or QA experience when degree requirement is not met.

Competencies:

• Interpersonal skills are vital.
• Requires the use of math and measuring instruments.
• Knowledge of FDA regulations.
• Knowledge of laboratory or test procedures.
• Ability to use laboratory equipment in a safe manner.

Certificates, Licenses, Registrations:

N/A

Travel:

N/A

Work Environment:

Worker exposed to extreme heat and cold with temperatures sufficiently high or low to cause marked bodily discomfort. Exposed to sufficient noise to cause worker to shout in order to be heard above the ambient noise level. Worker exposed to hazards such as proximity to moving mechanical parts. Works in laboratory, production line and warehouse environments.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms. Occasionally lift boxes of products 5-40 lb. frequently lift samples 1-5 lb. Clarity of vision at 20 inches or less, with the ability to distinguish colors and adjust eye to bring objects into sharper focus.