Quality Assurance Inspector

Job Title: QA Inspector, QALocation: Bedford, OHJob Type: Full-timeReq ID: 10511Description: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 materialsSamples 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 jackBe 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 USPDemonstrates good attention to detail and accuracyGood organizational skills and ability to multi-task and perform work in a timely mannerDemonstrates ability to work in a team environment with good communication skills and ability to communicate effectively with peers, department management and production personnelKnowledge of computer systems at a level proficient to navigate input and/or reference computerized dataMust have sound judgment and demonstrate good analytical skills to assess risk to issues related to the manufacturing processMust be able to pass the respirator requirements established for the Inspector positionAbility to stand/walk 85% of the shift to sample raw material and deliver to labsGood manual dexterity to repetitively manipulate syringes to sample filled units for in-process monitoringGood close visual acuity (eye exam required)Noise levels on production lines may be moderate to highAble to lift 15 lbs.Able to pull/push raw materials with use of a pallet jack.Preferred Qualifications:Prior QA experience preferredEqual 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.