Specialist Clinical QC - Compliance Analytical Development and Clinical QC

Location: New Haven CT (minimum 4days onsite)

This is what you will do:

Clinical QC Specialist is responsible for performing assigned tasks in support of maintaining overall GMP quality and compliance in the Clinical Quality Control laboratory within Analytical Development Quality Control Department.

The specialist will help identify and implement quality requirements under the direction of the CQC Compliance Manager; disseminating policies procedures assisting in internal audits and performing compliance related tasks within a regulated EDMS. Additionally this candidate will be responsible for equipment validation/qualification oversight and maintenance including maintaining calibration schedules and equipment qualification packages as well as associated change controls deviations CAPAs and audit responses.

You will be responsible for:

• Working in a fastpaced environment where product development supports unmet needs of patients with rare diseases.

• Responsible for generating reviewing providing assessments and maintaining out of specification (OOS) reports deviation reports CAPAs and Change Controls for Analytical Sciences cGxP operations as directed.

• Oversee equipment management and qualification program (i.e. System implementation upgrades oversee calibration and maintenance calendar service review approve and maintain equipment binders and logbooks)

• Assist with QA audits and design correction action to observations as assigned.

• Work with direct management to maintain and ensure alignment of the training matrix of ADQC (Analytical Development and Quality Control Department)

• Review of new procedures and proposed changes to current procedures for compliance with relevant and current regulatory and corporate requirements; presents findings as needed.

• Work with direct management to identify opportunities for improvement in systems and processes as well as makes recommendations for effective changes to ensure compliance with cGMP.

• Write and review methods SOPs qualification and validation protocols and reports and technical reports as assigned.

• Compile data and information related to assay and instrument performance.

• Maintain knowledge of current scientific principles and theories train other lab personnel and provide troubleshooting assistance as assigned in areas of competence.

• Ensure training is current for all job functions performed. Attend all required company training.

• Perform other related duties as assigned.

• Global role requiring domestic and international travel 05

You will need to have:

• A successful candidate must have a B.S. degree in a relevant field with 25 years of experience working in cGMP setting

• Strong verbal and written communication skills

• A broad knowledge of Pharmaceutical Quality Assurance regulatory compliance or quality control inclusive of cGMP FDA regulations familiarity with ICH guidelines and EU regulations.

• Proficient with various MS Office programs including Word Excel Outlook PowerPoint database management and statistical analysis

• Effectively organize and manage work responsibilities with minimal supervision.

• Effective time and project management skills with the ability to multitask.

• Experience with documentation and quality systems.

• Knowledge of pharmaceutical/biotechnology process.

The duties of this role are generally conducted in an office environment. As is typical of an officebased role employees must be able with or without an accommodation to use a computer; engage in communications via phone video and electronic messaging; engage in problem solving and nonlinear thought analysis and dialogue; collaborate with others; maintain general availability during standard business hours.

We would prefer for you to have:

• Previous experience with Trackwise.

• Previous experience with Veeva Vault eDMS.

• Previous experience with ValGenesis.

• Previous experience with Laboratory Information Systems (LIMS).

• Proficient with various MS Office programs including Word Excel Outlook and PowerPoint as well as SAS JMP statistical software.

Date Posted

10Apr2025

Closing Date

14Apr2025Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment training compensation promotion and other terms and conditions of employment based on race color religion creed or lack thereof sex sexual orientation age ancestry national origin ethnicity citizenship status marital status pregnancy (including childbirth breastfeeding or related medical conditions) parental status (including adoption or surrogacy) military status protected veteran status disability medical condition gender identity or expression genetic information mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation please contact Alexion participates in EVerify.