Quality Assurance Specialist
📋 Role Overview & Responsibilities
STAQ Pharma is currently hiring for a Quality Assurance Specialist to join their team for the 2nd shift here in Denver, CO.Schedule: Monday to Friday, 2 PM to 10:30 PM Pay: $55,000-$70,000/year The responsibilities of this individual will includeLead the document control program to ensure procedures meet CGMP requirementsManage training documentation and track employee compliance with training plansIssue GMP documents including Master Batch Production Records, Room and Equipment Logs, Document Change Orders, etc.Support in-process and finished product lot acceptance sampling and inspectionParticipate in investigations and problem solving of raw material, in-process, and finished product non-conformances with production personnel and/or supplierDevelop and implement corrective and preventive actions geared toward continuous process improvementsSupport the finished product label printing and issuance processWrite and implement standard operating procedures to meet and maintain FDA cGMP, USP, and state licensure requirementsProvide supplier related support to production and receiving inspection teamOther duties and tasks, as assignedQualifications and Education Requirements2-5 years of Quality Assurance experiencePharmaceutical, Medical Device, or biotechnology industry experience, preferably in support of manufacturingB.S. or B.A. on Sciences or a relevant field or equivalent experienceProfessional certification in Quality Engineering or Quality Auditing, preferredPreferred SkillsExcellent independent judgement and interpersonal skillsExcellent mathematical, written communication, and verbal communication skillsStrong technical writing skills and attention to detailKnowledge of and proficiency in the use of basic statisticsFamiliarity with Good Manufacturing Practices and FDA RegulationsSupplier Auditing experienceProficient in using Microsoft Word, Excel, PowerPoint, Outlook: experience with OneNote and Publisher a plus
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This position is located in Denver, CO with potential relocation and sponsorship assistance depending on candidate qualifications.
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