QA Inspector, QA

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Description:

Job Title: QA Inspector, QA

Location:Bedford, OH

Job Type:Full-time

About Us:

As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe.

Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them.

Description:

We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated QA Inspector, QA. In this role, you will be responsible for monitoring 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 Responsibilities:

• 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:

We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them:

• Associate’s degree in science OR Bachelor’s Degree with 0-2 years applicable laboratory, pharmaceutical manufacturing, or related experience.
• 0-2-year applicable laboratory or pharmaceutical production experience (QA preferred).
• 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…