BioSpace
Job Overview
QA Validation Specialist III role at BioSpace, based in Raritan, NJ. Exempt level position responsible for quality oversight of validation and qualification activities for equipment, systems, computer systems, and processes within a cell therapy manufacturing plant in a sterile GMP environment.
Key Responsibilities
Provide quality and compliance oversight for computer systems validation, process validation, equipment, utilities, and facility qualification, shipping validation, data integrity, and maintenance activities.
Review and approve qualification and validation documentation (specifications, protocols, reports).
Approve periodic review documentation for qualified equipment/systems (audit trails, user groups, system administration).
Provide expertise and solutions to issues regarding qualification and validation strategies and documentation.
Provide guidance on industry best practices and quality requirements for maintaining a compliant state for all site systems.
Assist in development of validation and qualification related policies, procedures, templates, forms.
Oversee data integrity of systems, instruments, and equipment used at the site.
Develop and evaluate quality processes and system standards to ensure compliance with applicable standards and global regulations.
Interact with Quality and Technical Services to assess and guide deployment of systems at the CAR‑T Raritan Site.
Approve change controls, SOPs, non‑conformances, and CAPAs associated with qualification/validation execution.
Perform tasks consistent with safety policies, quality systems, and cGMP requirements.
Drive continuous improvement.
Perform other duties as assigned.
Qualifications
Minimum 4 years relevant experience, preferably in a sterile manufacturing facility in quality assurance, manufacturing compliance, clinical quality, or cell therapy.
Knowledge of cGMP regulations and FDA/EU guidance related to GMP manufacturing of biopharmaceuticals; experience in supporting cell‑based products is a plus.
Strong knowledge of GxP compliance.
Experience with cGMP regulatory body audits.
Strong interpersonal and written/oral communication skills.
Ability to process complex information and make critical decisions with limited information.
Ability to work independently and manage a portfolio of ongoing projects.
Attention to detail and adherence to procedures.
Team player with positive attitude under minimal supervision.
Experience reviewing/auditing GMP documentation.
Proficiency with Microsoft Office applications.
Compensation Base pay range $93,463 – $122,670 USD.
Benefits Medical, dental, and vision insurance; 401(k) retirement plan with company match vesting day one; equity and stock options; eight weeks paid parental leave after three months; 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays; flexible spending and health savings accounts; life and AD&D insurance; disability coverage; legal assistance; supplemental plans (pet, critical illness, accident, hospital indemnity); commuter and family planning benefits; well‑being initiatives; peer‑to‑peer recognition programs.
EEO Statement Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend’s policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex, sexual orientation, gender identity, age, disability, national origin, marital status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by applicable law. Employment is at‑will. Legend may adjust base salary or other discretionary compensation at any time. Legend maintains a drug‑free workplace.
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Key Responsibilities
Provide quality and compliance oversight for computer systems validation, process validation, equipment, utilities, and facility qualification, shipping validation, data integrity, and maintenance activities.
Review and approve qualification and validation documentation (specifications, protocols, reports).
Approve periodic review documentation for qualified equipment/systems (audit trails, user groups, system administration).
Provide expertise and solutions to issues regarding qualification and validation strategies and documentation.
Provide guidance on industry best practices and quality requirements for maintaining a compliant state for all site systems.
Assist in development of validation and qualification related policies, procedures, templates, forms.
Oversee data integrity of systems, instruments, and equipment used at the site.
Develop and evaluate quality processes and system standards to ensure compliance with applicable standards and global regulations.
Interact with Quality and Technical Services to assess and guide deployment of systems at the CAR‑T Raritan Site.
Approve change controls, SOPs, non‑conformances, and CAPAs associated with qualification/validation execution.
Perform tasks consistent with safety policies, quality systems, and cGMP requirements.
Drive continuous improvement.
Perform other duties as assigned.
Qualifications
Minimum 4 years relevant experience, preferably in a sterile manufacturing facility in quality assurance, manufacturing compliance, clinical quality, or cell therapy.
Knowledge of cGMP regulations and FDA/EU guidance related to GMP manufacturing of biopharmaceuticals; experience in supporting cell‑based products is a plus.
Strong knowledge of GxP compliance.
Experience with cGMP regulatory body audits.
Strong interpersonal and written/oral communication skills.
Ability to process complex information and make critical decisions with limited information.
Ability to work independently and manage a portfolio of ongoing projects.
Attention to detail and adherence to procedures.
Team player with positive attitude under minimal supervision.
Experience reviewing/auditing GMP documentation.
Proficiency with Microsoft Office applications.
Compensation Base pay range $93,463 – $122,670 USD.
Benefits Medical, dental, and vision insurance; 401(k) retirement plan with company match vesting day one; equity and stock options; eight weeks paid parental leave after three months; 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays; flexible spending and health savings accounts; life and AD&D insurance; disability coverage; legal assistance; supplemental plans (pet, critical illness, accident, hospital indemnity); commuter and family planning benefits; well‑being initiatives; peer‑to‑peer recognition programs.
EEO Statement Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend’s policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex, sexual orientation, gender identity, age, disability, national origin, marital status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by applicable law. Employment is at‑will. Legend may adjust base salary or other discretionary compensation at any time. Legend maintains a drug‑free workplace.
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