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Familiarity with GxP, FDA, ICH, and OSHA requirements is preferred, along with experience using Minitab and Excel or relevant applications.","https://schema.org",{"og:url":78,"og:type":121,"og:title":59,"og:site_name":91,"og:description":61},"article",{"robots":123,"canonical":78},"index,follow",{"doc_id":125,"site_id":56},258986,1790470386,{"code":4,"msg":5,"data":128},{"doc_id":125,"user_id":129,"nickname":88,"user_avatar":130,"doc_module":9,"category_id":15,"category_name":16,"doc_title":59,"doc_description":61,"doc_content":131,"file_id":132,"file_url":133,"file_type":134,"file_size":135,"view_count":101,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":73,"language":136,"language_code":57,"site_id":56,"html_lang":57,"table_of_contents":137,"faqs":138,"seo_title":139,"seo_description":61,"update_tm":140,"read_time":9},687197207639,"https://ap-avatar.wpscdn.com/davatar_a8503ba1806abce46bf441b54a3ca4cd","Quality Assurance Analyst  \nFull Time  \nMt. Laurel, NJ  \nFLSA Status  \nNon-exempt  \nSalary  \nStarting at $20/hour based on experience plus twice a year bonuses  \nJob Summary  \nThe Quality Assurance Analyst is responsible for ensuring cGMP standards are maintained to ensure process and product quality.  \nEssential Duties and Responsibilities include the following. Other duties may be assigned.  \n• Assist in maintaining Master Batch Record documentation ([i.e. new](i.e. new) , revision, obsolete, etc.)  \n• Review Production Batch Record documentation for product release  \n• Assist in the completion of investigation  \n• Assist in the implementation of new and revised policies/procedures  \n• Assist in change control management  \n• Maintain compliance with company policies, regulatory requirements, quality specifications, safety standards, and sanitation practices  \n• Perform routine audits of processes and gap analysis relating to production operations  \n• Perform quality review of documentation and processes  \n• Ensure cGMP standards are maintained and coordinate efforts to build  \nRequired Education and Experience  \n• Bachelor’s Degree in Biological Science, Chemistry, Biomedical Engineering, or relevant field  \n• 1 years of experience in pharmaceutical/cosmetic manufacturing environment or relevant field, is preferred  \n• Familiar with GxP, FDA, ICH, OSHA requirements, is preferred  \n• Experience using Minitab, Excel, and/or relevant applications  \n• Must have knowledge of basic principles, theories and laws, policies and procedures that pertain to compounding  \n• Must be capable of wearing all protective wear as required. This includes, but not limited to; mask, gloves, gown, hairnet, safety goggles etc.  \n• Must be able to work with chemicals used in the preparation of compounds following any special safety precautions as required.  \n• Must have strong organizational skills and exceptional attention to detail  \n• Must exhibit punctuality and low absenteeism  \n• Able to work independently, as well as part of a team  \nCompetencies  \n• Communication Proficiency  \n• Problem Solving/Analysis  \n• Quality  \n• Results Driven  \n• Technical Capacity  \n• Thoroughness  \nSupervisory Responsibility  \nThis position has no supervisory responsibilities.  \nWork Environment  \nThis job operates primarily in an office environment. This position requires the use of standard office equipment, and frequent standing and walking.  \nPhysical Demands  \nThe physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  \n• Able to sit, stand, squat, kneel, reach and walk for prolonged periods of time  \n• May need to lift up to twenty-five (25) pounds on occasion  \nPosition Type and Expected Hours of Work  \nThis is a full-time position. Because of the nature of the business, work schedules may vary at times.  \nTravel  \nNo travel is expected for this position.  \nDisclaimer  \nThe above job description is intended to describe the general nature and level of work being performed by employees assigned to this job. It is not designed to capture or illustrate a comprehensive list of all responsibilities, duties, and skills required of employees assigned to this job.  \nAAP/EEO Statement  \nStokes Healthcare is an Equal Employment Opportunity and Affirmative Action Employer.","cbCaifbUFXSPAHIn","https://ap.wps.com/l/cbCaifbUFXSPAHIn","pdf",93823,"English","# Job Summary\n## Essential Duties and Responsibilities\n## Required Education and Experience\n## Competencies\n## Work Environment, Physical Demands, and Hours\n## Disclaimer and AAP/EEO","[{\"question\":\"What standards does the Quality Assurance Analyst ensure are maintained?\",\"answer\":\"The analyst ensures cGMP standards are maintained to support process and product quality, coordinating efforts to build compliance.\"},{\"question\":\"Which documentation and quality activities are included in the role?\",\"answer\":\"The role assists with maintaining Master Batch Record documentation, reviewing Production Batch Record documentation for product release, and performing quality review of documentation and processes.\"},{\"question\":\"What qualifications are required for this position?\",\"answer\":\"A bachelor’s degree in biological science, chemistry, biomedical engineering, or a relevant field is required. Familiarity with GxP, FDA, ICH, and OSHA requirements is preferred, along with experience using Minitab and Excel or relevant applications.\"}]","Quality Assurance Analyst Job Description | PDF",1789328352]