Durham, North Carolina, United States
1 day ago
IPQA Associate
Division Overview Aurolife was founded in 2008 as part of a group of companies that has a long history of excelling in generic pharmaceutical prouct development and manufacturing. Aurolife has a 10 year history of extraordinary manufacturing practices in the solid oral dose arena. The support and expertise of our parent organization has given Aurolife a jump start in building a solid pharmaceutical portfolio very quickly. The Aurolife family consists of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several formulations under manufacture, we have a robust pipeline of products. Aurolife's aim is to provide healthcare at economical prices to make this a healthier world to live in. Job Overview IPQA Associate is to perform all required in- process testing & sampling for Manufacturing and Packaging batches. Perform incoming inspections and outgoing inspections of finished product batches. Perform verifications using special instruments (Caliper, Balance, etc.) to assign final Approval to Labeling, Packaging and Raw Materials. Responsibilities Collection and inventorying of Retain and/ or Stability Samples Maintaining various logbooks to document the performance or completion of specific functions (ex. Material Receiving Log) Replace Temperature/Humidity Charts weekly if applicable Maintaining IPQA supply inventory Qualifications - Skills & Requirements REQUIRED 1-3 year experience performing in-process checks/verifications in the Manufacturing and Packaging areas of pharmaceuticals manufacturing environment. Must be a Team player able to effectively communicate with QA Supervisor, IPQA, Quality Control, Production, and Supply Chain to meet finished product release goals Be able to work long hours to support production requirements Be available for overtime, including weekends, as needed for production support Possess the ability to analyze information and make consistently good decisions ANY REQUIRED LICENSES/CERTIFICATIONS A familiarity with cGMPS, CFRs, OSHA and FDA regulations Experience with deviations /incidents and CAPA Our Company is committed to a policy of equal employment opportunity. It is the Company’s policy to administer all human resources actions and policies without regard to race, age, color, religion, sex, marital status, nationality, national origin, ancestry, mental or physical disability, affectional or sexual orientation, genetic information, atypical hereditary cellular or blood trait, citizenship status, any veteran status or any military service or application for any military service, or any other class protected by law. All employment decisions and personal actions, including, without limitation, recruiting, hiring, placement, promotion, compensation, benefits, transfers, terminations, layoffs, training, education and social and recreational programs, are and will continue to be administered in accordance with and to further the principle of equal employment opportunity. Performance of supervisors and employees alike will be evaluated on the bias of the equal opportunity efforts as well as other criteria. Education & Experience BA Degree 1-2 years experiece. Compensation Min USD $55,000.00/Yr. Max USD $65,000.00/Yr. Physical Requirements WAREHOUSE OR PRODUCTION POSITION – While performing the duties of this job the employee is required to: Regularly lift and/or move objects 10-50lbs Frequently required to stand, walk, stoop, kneel, crouch or crawl Occasionally required to sit and climb or balance Specific vision abilities required for this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust and focus The worker is subject to environmental conditions. Protection from weather conditions but not necessarily from temperature changes The worker is subject to both environmental conditions. Activities occur inside and outside Medium work Exerting up to 50 pounds of force occasionally, and/or up to 30 pounds of force frequently, and/or up to 10 pounds of force constantly to move objects. Additional Physical Requirements No Additional Requirements Blood/Fluid Exposure Risk Category I: Tasks involve exposure to blood, fluids or tissue.
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