icrunchdata Network Nicholasville, KY 40356, USA
Dec 08, 2019Full-time
Reports to: CEO Primary Objective of Position: The QA/QC Analyst ensures compliance with regulations governing the manufacturing, testing, warehousing, and distribution of pharmaceutical drugs. This position will support PPS’ overall cGMP compliance and the day-to-day performance of cGMP compliance throughout the company. All tasks and duties must be completed in accordance and compliance with HIPAA guidelines, State and Federal laws, and current company policies and procedures. Key Responsibilities: Assist in troubleshooting systemic GMP issues Provide support for compliance/QA-related projects Assist in "on the floor" activities (line clearances, product inspection, interim problem solving, etc.); internal audits Assist in conducting GMP investigations; specifically, root cause analyses, risk assessments, and impact evaluations Review and assign dispositions for materials and components used in batch manufacture Review of executed batch records Interact with clients (meetings, audits, investigations, etc.) Write, read, and revise technical reports Stay current on cGMP Regulations and Certifications Perform other duties as assigned Experience and Educations Requirements: Bachelor’s degree in related field 2 years of experience in Quality Assurance and Control field Must have an understanding of GMP Manufacturing Environment Experience completing record audits, data analysis and writing reports preferred Excellent organizational skills Ability to flourish with minimal guidance, be proactive, and handle uncertainty, critical thinking Proficient in Word, Excel, Outlook, and PowerPoint; Google Docs Computer proficient Other qualifications to be considered: Able to effectively prioritize to accomplish work tasks timely. Consistently meets deadlines and established goals. Consistently demonstrates commitment to the Company’s success and growth Self-motivated; works independently with minimal supervision Customer-focused (both internal and external customers). Ability to work with customers to find what they want, create solutions and ensure a smooth sales process. Embraces and adjusts to change. Ability to thrive in a quick sales cycle environment. Can identify problems/issues and participate in problem resolution as appropriate for job level Seeks and is open to feedback, interested in personal development and displays willingness to improve Takes accountability for own actions and work Recognizes and pursues opportunities to expand the firm’s services to clients as appropriate Consistently maintains professionalism While performing the duties of this Job, the employee is required to effectively communicate verbally, the employee is required to listen to the needs of co-workers and/or customers and have the ability to write and communicate information to other co-workers. Specific vision abilities required by this job include close vision. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Job Type: Full-Time Wage: $40,000-50,000 salary Hours: Varies; however, typically 9:00am-5:30pm, Monday-Friday Benefits: Health, Dental, Vision, Life, 401k Location: Anywhere ADA Disclaimer: In developing this job description care was taken to include all competencies needed to successfully perform in this position. However, for Americans with Disabilities Act (ADA) purposes, the essential functions of the job may or may not have been described for purposes of ADA reasonable accommodation. All reasonable accommodation requests will be reviewed and evaluated on a case-by-case basis. Tailor Made Compounding is an Equal Opportunity Employer.