MAIN DUTIES & RESPONSIBILITIES

• Ensure Safety & GMP’s are followed and all discrepancies are reported to the QA Supervisor
• Interact regularly with employees to assure a good flow of communication.
• Accurate communication with QA Working Lead and QA Supervisor regarding the status of production lines, raw materials and finished goods.
• Assure raw materials and finished goods are released for use.
• Make minor quality decisions (when acceptable quality limits are well defined by specifications) regarding the acceptability of products.
• Perform regular line inspections as per specifications in the batch record.
• Be a “back-up” for other QA Technicians.
• Communicate with QA Technicians the specification requirements for both raw materials and finished goods.
• Participate in general and line specific training.
• Initiates/conducts Non-Conforming Material Report investigations
• Assure compliance to CFR 21 Part 111.0.
• Provide line specific technical and procedural input in the creation and implementation of written procedures.
• Other duties may be assigned as necessary by the QA Supervisor.
• Accountable for the quality of work
• Accurate and timely recording of information on specified documents
• Proper use and care of equipment and materials issued to work area

REQUIREMENTS

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily as outlined above.
• Ability to operate/use personal computer, office equipment, telephone, and various word processor and spreadsheet software.

• Ability to exchange information with others clearly and concisely; to present ideas, facts, and technical information.

• Ability to work with minimal direct supervision.

• Ability to work well with others in a team environment.
• Zero (0) to one (1) year of related experience preferred or additional years of education and experience may be substituted for each other, as determined by Human Resources and the QA Manager.
• Ability to effectively present information and respond to questions from QA Supervisor, other internal departments and Customers.

• Must be able to understand, speak, read and write in English in order to perform the essential functions of the job as they relate to comprehension of laws, regulations, standards, documents and other internal and external communications.

• Ability to keep proprietary information confidential is critical to this position.
• Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. Knowledge of both standard and metric systems.
• Must be able to lift 25 pounds.

WORKING CONDITIONS

• Production areas, which may include the following conditions:
  • High noise levels

  • Dust, fumes and odors
• Subject to various means of business travel (planes, trains, busses, automobiles)

Note: This job description is not intended to be all-inclusive. Salary is dependent upon experience and internal and external salary conditions. This document does not create an employment contract, implied or otherwise, other than an “at will” employment relationship.