Sr. QA Specialist (Hybrid)

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.

Responsibilities

• Essential Functions

  * Review / approve Master Batch Records (MBRs) and Executed Production Batch Records (EPBRs) of Eisai products manufactured at approved Contract manufacturing/packaging facilities.

  * Ensure that all manufacturing batch records are received and executed per procedure and meet all quality requirements by reviewing for completeness, compliance, and accuracy to support product lot disposition.

  * Provide quality oversight, review, and management for quality records such as, but not limited to local and global change management, vendor and customer/product complaints, deviations, CAPAs, training and OOS/OOT investigations.

  * Technical writing ability to author QA department SOPs.

  * Provide knowledgeable understanding of the chemistry and microbiological principles associated with a pharmaceutical manufacturing environment as well as plant utilities services such as compressed process air, clean steam, and Water (e.g. purified and/or Water For Injection) to support function groups.

  * Review / approve QC Analytical Testing, Stability Data and Certificates of Analysis; Validation Protocols and Study Reports.

  * Review Study Reports for inclusion in CMC regulatory submissions.

  * Participate in FMEA Risk Assessments.

  * Participate in process improvement activities aimed to add efficiency to Quality processes.

  * Collaborate and assist in resolving Eisai Network and Business Partner queries and requests.

  Requirements

  * Bachelor's degree (preferably in science related discipline).

  * Minimum 5 years' experience in FDA or equivalent regulated industry and at least 4 years' experience performing Quality Assurance functions (i.e.., SOP authoring/reviewing, batch record review/product disposition, investigations into deviations and/or out of specification results, customer complaints, change control, etc.)

  * Strong working knowledge of current Good Manufacturing Practices (cGMPs), Quality Management Systems (QMS) and International Conference for Harmonization (ICH) guidelines required

  * Preferred advanced understanding and working knowledge of support/upstream/downstream manufacturing technologies including manufacturing techniques, maintenance, knowledge of technical document writing and familiarity with 21 CFR, Parts 210 and 211 GMPs.

  * Quality Person in Plant experience desired

  * Strong oral and written communication skills.

  * Ability to interpret and apply cGMPs, relevant laws, guidance documents and directives

  * Strong attention to detail and ability to work independently.

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Eisai Salary Transparency Language:

Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills.

Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit https://us.eisai.com/careers-at-eisai/benefits.

Certain other benefits may be available for this position, please discuss any questions with your recruiter.

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.

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