QA Quality Systems Specialist II

Organization
Luitpold Pharmaceuticals, Inc.
Job Location
New Albany, OH
Job Description

PharmaForce, Inc. is a pharmaceutical research, development and manufacturing company based in the Columbus, Ohio area specializing in the sterile injectable market. PharmaForce is wholly owned by parent company, Luitpold Pharmaceuticals, a division of Japanese pharmaceutical company Daiichi Sankyo. We are an Equal Opportunity Employer (Minority/Female/Veterans/Individuals with Disabilities). 

Nature and Scope 
The Quality Systems (QS) Specialist II will be responsible for effectively ensuring non-routine events are investigated and documented in accordance with company SOPs, policies and cGMPs. This is a cross-functional position that interacts with all departments at PharmaForce. The incumbent will participate in planning and organizing the quality systems to meet or exceed the company's quality expectations. 

Essential Duties and Responsibilities 
Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. 

• Under the direction of the Quality Systems (QS) Manager, the QS Specialist II will: 
 • Coordinate specific departmental activities with the goal of maximizing efficiency of management control systems, programs, policies, work methods and procedures. Collaborate with QS staff, colleagues, leadership to ensure that goals and objectives are accomplished in a timely manner. 
• Interact and maintain relationships with colleagues, investigators, and staff in facilitating department objectives and ensuring positive working interactions. 
 • Provide detailed attention to carry out activities in support of the QS Department with inter-related activities of other programs, departments or staff and communicates within the appropriate timeframe. 
• Work independently and recognize daily needs to be met with minimal supervision while delivering timely results. 
• Effectively manage multiple tasks and work under pressure. 
 • Ensures any non-routine events associated with the manufacture of safe, pure, and effective sterile pharmaceuticals are investigated and documented in accordance with company SOPs, policies and cGMPs and within assigned timelines. Identify trends, evaluate metrics and provide support for internal audits under the direction of the QS Manager. 
• Ensure event, deviation and CAPA timelines are maintained through inter-department communication. 
• Facilitate and lead assigned investigations involving multiple investigation areas. Gown and enter aseptic manufacturing to support investigations or any other QA activities. 
• Review Quality Systems data for trends within assigned area of support and report to functional area management, QA and QS Manager. 
• Ensure appropriate corrective action plans are implemented and verified for effectiveness in accordance with company SOPs, policies and cGMPs. 
 • Facilitate and participate in initiatives to address compliance gaps identified during investigations with minimal assistance. Provide quality system level assessments and reviews, author and facilitate change requests. 
 • Confirm the completeness, accuracy and consistency of all work so that it meets the standards of quality. Identify errors and inconsistencies and initiate resolution to ensure high quality. 
• Support functional area managers in internal audit response activities. 
• Provide support to Senior Management for all internal third party audits. 
• Participate in continuous improvement initiatives to improve the Quality System. 
 • Identify and participate in initiatives to continuously improve the Quality System. Author and facilitate change requests as required. 
 • Represent the QS group in continuous improvement committees or working groups. Incorporate process improvement tools to guide working groups. Facilitate first pass acceptance of identified deliverables. 
• Position has responsibilities at multiple locations in central Ohio.



Requirements: 

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. 

• Bachelor's Degree required. Quality certification preferred (e.g. ASQ). 
• 5 years of quality assurance experience in an FDA regulated environment is required. 
• Demonstrated analytical and critical thinking skills. 
• Knowledge of applicable FDA regulations and established expertise in interpreting and applying to the organization required. 
 • Excellent English communication skills, both oral and written, and comprehension are required. Ability to effectively present information to top management, employees, or customers. 
• Direct experience investigating any issues that may occur during cGXP activities and summarizing investigations in written format. 
• Demonstrable experience in root cause analysis, impact assessment, and risk management. 
• Exceptional organization and time management skills. Proven ability to multitask efficiently. 
• Detail-oriented person with the ability to work independently, accurately and assess priorities. 
 • Ability to respond quickly to problems or changes in priorities and work with a team to effect solutions; sense of urgency. 
 • Ability to work in a team environment. Ability to work in multidiscipline environments. 
• Advanced computer skills to include Microsoft Word, Excel, Access, Visio or comparable software, PowerPoint, email. 
 • Must possess an understanding of how the pharmaceutical process pathway works, specifically how each of the various disciplines interact and their respective needs to achieve success. 
• Self-directed requiring minimal supervision; urgency, and attention to detail and problem solving. 
 • Perform any other tasks/duties as assigned by management. 
 • We all must embrace the QUALITY culture. 

Physical Environment and Physical Requirements 

• While performing duties of the job, incumbent is occasionally required to stand; walk; sit; use hands to finger, handle or feel objects, tools or controls; reach with hands and arms; balance; talk and hear.

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