Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionSummary:Investigates and observes Operations and Quality Operations departments to assure that FDA current Good Manufacturing Practices, company SOPs and product registrations are followed and maintained. Conducts investigations of batches, preps, lots, equipment, and facilities in accordance with the Code of Federal Regulations. Assists the Operations and Quality Operations departments in satisfying all FDA and DEA requirements.Essential Functions:
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Required Qualifications:HS Diploma or GED is requiredBachelors Degree in Chemistry, Biology, Engineering or relevant science preferred.Minimum of 3+ years' experience in Records, Investigation Writing, QC, QA, Analytical Development, Process Engineering, Engineering services or manufacturing is requiredRequires a basic understanding of the practices, principles and theory of GMP Services. Must be able to identify and analyze unique problems.Equivalency:Equivalent combinations of education, training, and related work experience may be considered.Knowledge, Skills and Abilities:Extensive knowledge of GMPExcellent problem solving and writing skills.Strong Proficiency in Microsoft Office SuitesAbility to work on multiple projects simultaneously.Strong attention to detailPhysical Requirements:Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.#qualitycinci
