Job Title: Quality Control Technician 1

 

Job Summary: The Quality Control Technician is responsible for following the company quality control program, which includes inspection of incoming materials, production lines, in process inspection, dispensing of raw materials to production and some laboratory analysis.

Essential Duties and Responsibilities:

A Quality Control Technician shall follow and help establish procedures for maintaining high standards of product quality, reliability, and safety.

Functions include but are not limited to:

  • Proper handling of chemicals, including hazardous materials,  according to lab chemical hygiene plan
  • Inspection and documentation of incoming containers, closures and labeling.
  • Sample, test and approval of incoming raw materials.
  • Sample, inspect, and analyze finished product.
  • Communicate with Production, Regulatory Affairs, Quality Assurance regarding the disposition of raw materials and finished products.
  • Perform on-line product inspections and document findings.
  • Production equipment inspections
  • Miscellaneous clerical functions pertaining to QC records
  • Assisting in weighing out and dispensing raw materials to production
  • Perform equipment calibration and maintenance, as required.
  • Assist in the cleaning and organization of the laboratories.
  • Perform other duties as assigned.                                                                                                                          

Other Duties:

This individual is part of the CGMP Team and Fulfillment Team, which is concerned with product quality and safety. The candidate must be well organized and have a keen eye for detail. He/she must be a team player who can communicate effectively both orally and in writing.                                                                                                                                    

Knowledge and Skills:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Ability to read and interpret documents such as safety rules, operating and maintenance instructions, procedure manuals and Material Safety Data Sheets (MSDS).  Ability to write routine reports and correspondence.  Ability to speak effectively before groups of customers or employees of the organization.

Ability to calculate figures and amounts such as proportions, area, circumference, volume, use scientific notation, unit factoring and unit conversion. Ability to apply basic concepts of algebra and geometry.

Ability to apply common sense understanding to carry out detailed but uninvolved written or oral instructions. Ability to deal with problems involving a few concrete variables in standardized situations.

To perform this job successfully, an individual should have intermediate computer skills including: word processing, spreadsheet programs and database management.

Oral Communication Skills

Professionalism

Math Aptitude

Reading Skills

Filing

Project Management

Technical Communication

Organization

Time Management

Customer Service

Planning

Multi-Tasking

Education and Work Experience:

An Associate's Degree in one of the sciences or 2 years equivalent experience. The candidate should also be proficient in MS Word and Excel. Preferred experience includes: Quality Control, Quality Assurance or Inspection, at a GMP, FDA or USDA regulated facility. Familiar with 21 CFR 210 and 211, cGMP of Drugs and Finished Pharmaceuticals.                                                                                                                                                            

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The noise level in the work environment is usually moderate.

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.

The employee must be able to lift and/or move up to 50 pounds.  While performing the duties of this job, the employee is regularly required to stand; walk; use hands; reach with hands and arms; talk or hear and taste or smell. The employee is occasionally required to sit, climb, balance, stoop and kneel.