Quality Control Technician I

Posting Date: 07.28.2020

Status: Hourly, non-exempt

Department: Quality Control

Reports to: Manager, Quality Control

Job Summary:

In this role you will perform work required to ensure Company product quality is maintained at standards set forth by Company Quality System and mandated by regulatory agencies such as the FDA, ISO, and CMDR.

Duties and Responsibilities:

  % Time Essential/Non-Essential
1. Perform testing of in-process components for Molecular products TBD Essential
2. Perform final release testing for Molecular products TBD Essential
3. Troubleshooting of technical and quality issues TBD Essential
4. Undertake new procedures and observe proper safety precautions TBD Essential
5. Able to perform technical procedures and use laboratory equipment TBD Essential
6. Review batch records TBD Essential
7. Calibrate/maintain laboratory equipment TBD Essential
8. Maintain Good Manufacturing/Laboratory Practices (GMP/GLP) TBD Essential
  The above statements are intended to describe the principal functions of the position.  They are not intended to encompass all duties. There may be additional duties assigned by your supervisor based on business needs.

Qualifications:

MINIMUM QUALIFICATIONS:
  1. Associates degree in Biology, Chemistry, Life Sciences or other related technical field or equivalent combination of education and experience
  2. 1+ years of laboratory and/or quality control experience
PREFERRED QUALIFICATIONS:
  1. 2+ years' experience in a regulated industry
  2. 2+ years' experience with GMP, FDA, ISO, and USDA regulations
  3. Prior experience in the following areas:
    • Pipette experience
    • pH meter
    • ELISA assays
Individuals should possess the following competencies to perform the job successfully:

Competencies:

  1. Working knowledge of internet software, Fourth Shift, and MRP Inventory/Manufacturing software and Microsoft Office Suite (Outlook, Excel, and Word).
  2. Knowledge of enzyme and/or immunochromatographic assays, inspection/measurement systems, systematic troubleshooting, statistics and data analysis

Working Conditions:                                          

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. The employee is frequently exposed to work near moving mechanical parts, vibration and an environment with moderate noise levels.  May be required to work in a controlled environment requiring special garb (ex. coats, hairnets, and facial hair guards), gloves and prohibiting specific items.

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 these essential functions. An operator must:
  • Be able to move body through different positions to allow safe maneuvering of product from carts/totes and tables to/from the machine
  • Be able to adhere to all safety procedures and practices
  • Be able to adhere to all Current Good Manufacturing Practices (cGMP) while utilizing tools, computers, and safety devices to efficiently complete assigned work
  • Have the ability to work in a standing position on a constant basis is required when performing job. The duration may be up to the scheduled work hours. Sitting may be required on an occasional to frequent basis
  • Be able to walk, squat, crouch, stoop and bend forward/sideways without aids/assistive devices on occasional to frequent basis
  • Be able to push and pull with light to moderate force
  • Have sufficient strength and movement in upper body/arms and hands to perform repetitive forward reaching
  • Be able to extend hand(s) and arm(s) in any direction while handling parts
  • Be able to seize, hold and grasp items typical of this job with good dexterity with both hands, such as tweezers, nippers and small cutting tools throughout the work shift
  • Have good eye-hand coordination
  • Be able to pinch and work with the fingers throughout the workday
  • Have the ability to lift, lower and carry up to 25-30 lbs. on an occasional basis (1/3 of workday) and 10-20 on a frequent basis (2/3 of workday)
  • Have specific vision abilities required by this job include: color and shading discrimination, close vision, distance vision, peripheral vision and ability to adjust focus.  Must possess sight and hearing senses or by the use of prosthetics that enable these senses to function adequately
  • Be able to correctly orient/layout parts using reasoning and relation problem solving
Based on the weight and frequency of material handling and required non-handling activities, the typical day-to-day job demands of an Operator carry the physical demand rating classification of Medium.  This rating is set forth by The United States Department of Labor. *Please Note: Physical demands vary by job title, plant location, and product design. Tessy is an equal opportunity employer.

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