Title:  QA Inspector, QA

Job Title :QA Inspector I-1st  Shift 

 JOB PURPOSE

The QA Inspector monitors in-process product quality for Filling and Inspection and Packaging of parenteral products. The QA Inspector is responsible for performing visual and functional testing of product against statistically based sampling plans. In addition, the QA Inspector performs routine inspection and testing of components in accordance with Standard Procedures and specifications as required by production scheduling. In performing the above duties, the individual is responsible for accurately and clearly documenting test results in accordance with cGMPs. This position participates in rotation for weekend coverage and as needed during the work week.

KEY ACCOUNTABILITIES:

• Regular and predictable onsite attendance and punctuality.
• Performs in-coming tasks which include pallet checking, raw material sampling, review of test results, release of components, raw materials and production supplies.
• Contacts QA Coordinator or QA Supervisor for daily line assignments.
• Samples/Checks/Verifies Controlled Substances during in-coming monitoring and raw material sampling.
• Must pass frocking qualification for controlled areas and pass the respirator requirements for sampling raw materials 
• Samples using analytical instrumentation such as Analytical balances, glove boxes and compressed gases.
• Be able to push pallet(s) of raw material with the use of a pallet jack
• Be able to lift 15-20 lbs.
• Maintains good housekeeping and safe working conditions. 
• Accurately and clearly documents sampling/ inspection/test results in accordance to department and site SOPs.
• Performs other duties to support production or validation as determined by QA Supervisor.
• Participates in rotation for weekend coverage to support production. May work flexible hours and overtime on a short notice to support production.

QUALIFICATIONS

• Minimum:    Associate’s degree in science or equivalent with 0-2 year applicable laboratory, pharmaceutical manufacturing or related experience (QA preferred)

EXPERIENCE

• Minimum:    2-year applicable laboratory or pharmaceutical production experience (QA preferred).

SKILLS

• Possesses proficient mathematical skills (addition, subtraction, multiplication, division, algebra, unit conversions, rounding significant figures, dividing polynomials, solving rational equations).
• Familiar with cGMPs, EU, CFR and the USP
• Demonstrates good attention to detail and accuracy
• Good organizational skills and ability to multi-task and perform work in a timely manner
• Demonstrates ability to work in a team environment with good communication skills and ability to communicate effectively with peers, department management and production personnel
• Knowledge of computer systems at a level proficient to navigate input and/or reference computerized data
• Must have sound judgment and demonstrate good analytical skills to assess risk to issues related to the manufacturing process
• Must be able to pass the respirator requirements established for the Inspector position
• Ability to stand/walk 85% of the shift to sample raw material and deliver to labs
• Good manual dexterity to repetitively manipulate syringes to sample filled units for in-process monitoring
• Good close visual acuity (eye exam required)
• Noise levels on production lines may be moderate to high
• Able to lift 15 lbs.
• Able to pull/push raw materials with use of a pallet jack.