QA Data/Document Review Associate

Organization
Luitpold Pharmaceuticals, Inc.
Job Location
Columbus, 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 
To provide a comprehensive Quality compliance review of cGMP analytical data and results for raw materials, in-process and finished product release, stability program results and summaries, and raw data related to the Validation of pharmaceutical processes. To facilitate corrections and clarifications to the reviewed data and provide a final approval of the records. 

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. 

• Provides quality assurance review of laboratory raw data and reports including analytical worksheets, test summaries and stability summaries (for chemistry related data). 
• Participates in identifying quality process improvements to increase efficiencies and performance of systems, operations and personnel relating to the QA Data Review process. 
• Writes and revises SOP’s and other GMP documentation as needed. 
• Ensures all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP, compendia, and all applicable FDA Guidance document requirements and other company requirements. 
• Participates in other Quality System activities with other team members as needed. 
• Perform any other tasks/duties as assigned by management. 
• We all must embrace the QUALITY culture.

Requirements: 

Requirements 

• Bachelor’s degree in the Physical Sciences, Mathematics or related field required. 
• Minimum 2 years experience in a chemical testing, laboratory setting with a working knowledge of wet chemistry and instrumental analysis techniques and microbiological assays. 
• Demonstrates extreme attention to detail to achieve quality results. 
• Ability to perform multiple activities at the same time and producing outstanding results to meet required deadlines. 
• Exercises a willingness to learn and take on added responsibilities as needed. 
• Excellent organizational, interpersonal and communication skills (oral and written) to work in a team environment. 
• Ability to work overtime as needed. 

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, hear, and see.

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