Quality Assurance Inspector

RXinsider LTD.; Bedford (OH); On-site; USD 48,000 - 72,000; Full time

Job summary

Hikma Pharmaceuticals USA Inc. in Bedford, OH, seeks a QA Inspector to monitor in-process quality for filling, inspection, and packaging of parenteral products. You will perform visual and functional testing and document results in accordance with cGMPs.

The role requires standing for long periods, lifting up to 15 lbs, and passing frocking/respirator requirements. A science degree with 0–2 years QA experience is preferred.

Qualifications

• Associate’s degree in science or Bachelor’s Degree with 0-2 years applicable lab/pharma experience.
• 0-2 years applicable laboratory or pharmaceutical production experience (QA preferred).
• Familiar with cGMPs, EU, CFR and the USP.
• Demonstrates attention to detail and accuracy.
• Good organizational skills and ability to multi-task.

Responsibilities

• Regular and predictable onsite attendance and punctuality.
• Performs in-coming tasks including pallet checking, raw material sampling, review of test results, release of components and supplies.
• Docs sampling/inspection/test results accurately per SOPs.
• Participates in weekend rotation and may work overtime as needed.

Skills

QA testing

Attention to detail

Teamwork

Communication skills

Mathematical skills

SOP reading

Education

Associate’s degree in science

Bachelor’s degree (0-2 years experience)

Tools

Analytical balances

Glove boxes

Pallet jack

Job description

Job Title: QA Inspector, QA

Location: Bedford, OH

Job Type: Full-time

Req ID: 10511

Description:

We continue to be 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 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.

Preferred Qualifications:

• Prior QA experience preferred

Equal Opportunity Employer:

Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.