Job description


  • Entry level
  • No Education
  • Salary to negotiate
  • Reynoldsburg


Job DescriptionSUMMARY:Reviews, coordinates, and assists to ensure nonconformances are adequately investigated for determination of root cause and product impact per FDA regulations. In addition, ensures that corrective and preventive actions (CAPA) are identified and implemented to prevent/reduce reoccurrence. Oversee product complaint investigation process to ensure they are adequately investigated, within defined timeframes. ESSENTIAL FUNCTIONS:Initiate, track monitor, facilitate closure, and QA review of deviations, investigations, out ofspecification (OOS), and out of trend (OOT) reports for compliance to FDA regulations and other guides/guidelines. Author QA deviations/investigationsProvide cGMP guidance to functional groups such that all discrepancies are closed within defined timeframes.Issue reports of all open non-conformances and track completion/closure.Manage CAPAs to ensure timely closure of actions resulting from various types of investigationsfrom the QC laboratories. Provide metrics to track/trend non-conformances and recommend additional actions to prevent reoccurrence. Assist during regulatory inspections or other audits as requiredProvide training to function areas on compliance issuesOther duties as requiredQUALIFICATIONS:To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.ESSENTIAL KNOWLEDGE, SKILLS AND ABILITIES:Excellent interpersonal, oral, and written communication skills.Proficient with computer programs. TrackWise experience preferred.Ability to meet attendance standards. All full-time employees are required to work a 40-hr week. At times it may be necessary to work additional hours in order to get the required tasks accomplished to meet deadlines. Qualifications: EDUCATION AND EXPERIENCE:Bachelor’s degree and a minimum of 5 years’ experience in a Quality Systems relating to deviations, investigations, out of specifications (OOS), non lab out of specifications, corrective and preventive actions (CAPA), and product complaints. In addition, experience in performing cGMP related training. Five years of previous quality experience in pharmaceuticals or related field.PHYSICAL DEMANDS, MENTAL REQUIREMENTS, AND WORK ENVIRONMENTThe physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.This position requires prolonged sitting. Additionally, requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator and other office equipment. Requires normal range of hearing and vision to record, prepare and communicate appropriately. Additional physical and mental requirements include:Ability to hear accurately the spoken word with moderate office noise or plant noiseAbility to apply deductive reasoning and understand complicated issuesAbility to receive instructions and follow work rules and company policiesAbility to follow safety and security practicesAbility to meet deadlines and effectively deal with office stressAbility to accurately communicate ideas, facts and technical informationCompany Overview: Akorn, Inc. is a niche pharmaceutical company that develops, manufactures and markets generic and branded prescription pharmaceuticals as well as animal and consumer health products. We specialize in difficult-to-manufacture sterile and non-sterile dosage forms including: ophthalmics, injectables, oral liquids, topicals, inhalants, and nasal sprays. Akorn markets its products to retail pharmacies, ophthalmologists, optometrists, physicians, veterinarians, hospitals, clinics, wholesalers, distributors, group purchasing organizations, and government agencies.EEO Statement: Akorn, Inc. is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.Auto req ID: 1750BR

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