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Join a leading medical equipment company as a QA Inspector, responsible for ensuring product quality and safety through routine assessments and compliance with GMP and FDA standards. Ideal candidates should possess attention to detail and strong communication skills, with some experience in the pharmaceutical or biotech industry preferred. This entry-level, full-time role offers an opportunity to engage in critical quality assurance tasks and promote continuous improvement.
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Responsible for endorsing process and product quality, efficacy, and safety through the routine assessment of plant operations and finished products. Responsible for ensuring adherence to the regulatory and procedural requirements that govern those operations and products. Monitor product quality through the performance of required visual and functional testing. Maintain a working knowledge of statistically based Sampling Plans and their applications. Promote process control through activities in support of equipment and process validations. These activities are primarily product checks that support or refute validation studies. Monitor processes through the implementation of World Class Manufacturing Strategies, including Statistical Process Control (SPC). Responsible for generating and interpreting SPC control charts. Ensure the accuracy of measuring and testing equipment through the performance of calibrations. Perform periodic audits of manufacturing practices and local procedures. Procedural changes in response to these audits may be initiated and coordinated by the QA inspector. Support the corrective and preventive action program by assisting with expectation situations. Promote continuous improvement through participation (i.e. team leader / facilitator or major contributor) in Process Management Team program. Knowledge of GMP documentation and FDA required. Demonstrated attention to details and accuracy required. Must have good communication skills. General knowledge of quarantine and warehouse operation helpful. May be required to work flexible hours and overtime on short notice. Associates with 0 years related experience or High School diploma with 1+ years related experience. Experience in a pharmaceutical or Biotech industry helpful. Familiarity with cGMP and FDA requirements preferred.
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