Sr. QA Associate - Exton at Eisai in Exton, Pennsylvania

Job Description:

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.

Job Summary

• Performs review and approval of Clinical and Commercial Master Batch Records and Executed Production Batch Records of Eisai Products manufactured at the Exton BPP, to ensure that all reviewed records have been executed per procedure and meet all quality requirements.




• Performs Production Batch Record review of Eisai products manufactured by contract facilities. The review may include associated deviations, as well as implementing and tracking corrective / preventive actions, change controls and technical documents (stability protocols/reports, method and process development).




• Provides Quality Person in Plant support for products manufactured at the Exton facility.




• Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies, and that the performance and quality of services conform to established standards and agency guidelines.




• Ensures the quality assurance programs and policies and procedures are maintained and revised biennially.




• Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations and agency guidelines to assure compliance.




• Performs review and approval of QC Analytical Testing and Stability Data, cleaning validation documents (internal and external) for equipment, method and processes




• Participates in the review of FMEA Risk Assessments.




• Performs CMC QC check for Regulatory submissions (IND, IMPD, BLA).




• Performs review and approval of Global Investigator Brochures and Technical Memos.




• Conducts investigations in collaboration with Operations to fully understand the impact of the deviation and determine appropriate CAPA.




• Support quality efforts pertaining to the development, testing and production of several different therapeutic antibodies.




• May represent QA on cross-functional department teams and function in the absence of department manager.




• Performs internal audits and external audits requiring occasional domestic and international travel as needed.

The Sr. QA Associate is an individual contributor with no direct reports and is expected to perform their core job functions with minimal supervision and input from quality management.

Essential Functions

Reviews Master and executed clinical and commercial production batch records in a timely manner, ensuring that records are in compliance with GMP's and standard operating procedures.

• Conducts, writes and performs risk assessments for investigations/deviations in collaboration with Operations to fully understand the impact of any deviation. With assistance from the Operations, determines root cause and assigns appropriate CAPA.




• Drafts or contributes to QA documentation, including investigation reports and standard operating procedures as needed.




• Reviews QC analytical reports, CMC sections for regulatory submissions and executed production batch records for products manufactured by contract facilities.




• Provide Quality Person in Plant support for products manufactured at the Exton facility.



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  Other duties as assigned to facilitate ongoing Eisai Exton quality activities including, but not limited to:

  
  

  • Represents QA at departmental meetings and on cross-functional department teams involving Eisai Exton and external partners

  
  

Requirements

• Bachelor's degree in a Life Science is required. Preferred Chemistry or Biology degree.




• 8+ years' experience in FDA or equivalent regulated industry (biotechnology or pharmaceutical industry)




• 8+ years' experience performing Quality Assurance functions (for example; SOP and protocol writing, batch record review, investigations into deviations and out of specification results).




• Prior experience working in a cleanroom environment and/or on the manufacturing floor required.




• Experience working with regulatory agencies (i.e., FDA, MHRA, PMDA), required.




• Strong working knowledge of cGMP, Quality Management System and ICH guidelines required; prior experience with regulatory inspections required.




• Demonstrated experience performing batch record review and investigating product complaints.




• Excellent communication skills (oral and written) and demonstrated organizational skills.




• Critical thinkingand effective decision-making skills with ability to identify issues requiring further attention, and ability to initiate and facilitate resolution of those issues in a timely & professional manner.




• Strong attention to detail a must.

• Strong interpersonal relationship skills; ability to work effectively and gain consensus across the organization.




• Continuous Improvement experience preferred.




• Computer skills including a working knowledge of Microsoft Office (PowerPoint, Word, Excel,Project, Visio and Microsoft TEAMS).




• Working knowledge of TrackWise, LIMS and SAP desirable.




• Ability to work independently with minimal supervision and direction.

Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.

Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:

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