QA Investigations Lead III
Scorpion Therapeutics, Raritan, NJ, United States
QA Investigations Lead III
Location: Raritan, NJ
This position is part of the Quality team.
Role Overview The QA Investigations Lead is responsible for providing quality oversight over the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment. This includes supporting and approving manufacturing investigations, ownership of various department projects, and tracking of quality metrics while ensuring high quality and compliant product supply.
Key Responsibilities
Support compliance activities for site Quality Operations in accordance with Legend standards, procedures and cGMPs.
Collaborate with site personnel to provide guidance and determine resolution for manufacturing issues.
Ensure accurate and timely maintenance and review of manufacturing investigations, CAPAs, change controls and complaints.
Review and approve manufacturing procedures.
Support regulatory inspections and audits by ensuring inspection readiness within facility.
Perform internal housekeeping audits.
Perform analysis on quality indicating data and identifying trends.
Provide oversight for trending of quality compliance metrics.
Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals.
Works in a collaborative team setting with quality counterparts that include Manufacturing Operations, Operations Technical Support, Maintenance, Supply Chain and Planning.
Requirements
A minimum of a Bachelor’s Degree in Science, Engineering or equivalent technical discipline is required.
A minimum of 4 years relevant work experience is required. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy.
Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue Practices.
Great attention to detail and ability to follow the procedures.
The candidate must be highly organized and capable of working in a team environment with a positive attitude under minimal supervision.
Good written and verbal communication skills are required.
Ability to summarize and present results, and experience with team‑based collaborations is a must.
Must be able to interpret problems and effectively determine appropriate resolutions that ensure compliance and minimize risk.
Must exhibit strong leadership skills and effectively develop others.
Ability to collaborate well with stakeholders, customers and peers.
Must exhibit strong decision‑making ability and think creatively while maintaining compliance and quality.
Must be able to discern the criticality of issues and to communicate to management regarding complex issues.
Ability to manage conflict and issues that arise with internal or external customers.
Benefits and Pay Base pay range: $81,273 – $106,669 USD.
Other Types of Pay: Performance‑based bonus and/or equity is available to employees in eligible roles.
Benefits and Paid Time Off: Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. Eight (8) weeks of paid parental leave after three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short‑and‑long‑term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. Voluntary commuter benefits, family planning and care resources, well‑being initiatives, and peer‑to‑peer recognition programs are also offered.
Please note: These benefits are offered exclusively to permanent full‑time employees. Contractors are not eligible for benefits through Legend Biotech.
EEO Statement It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.
Employment is at‑will and may be terminated at any time with or without cause or notice by the employee or the company.
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This position is part of the Quality team.
Role Overview The QA Investigations Lead is responsible for providing quality oversight over the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment. This includes supporting and approving manufacturing investigations, ownership of various department projects, and tracking of quality metrics while ensuring high quality and compliant product supply.
Key Responsibilities
Support compliance activities for site Quality Operations in accordance with Legend standards, procedures and cGMPs.
Collaborate with site personnel to provide guidance and determine resolution for manufacturing issues.
Ensure accurate and timely maintenance and review of manufacturing investigations, CAPAs, change controls and complaints.
Review and approve manufacturing procedures.
Support regulatory inspections and audits by ensuring inspection readiness within facility.
Perform internal housekeeping audits.
Perform analysis on quality indicating data and identifying trends.
Provide oversight for trending of quality compliance metrics.
Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals.
Works in a collaborative team setting with quality counterparts that include Manufacturing Operations, Operations Technical Support, Maintenance, Supply Chain and Planning.
Requirements
A minimum of a Bachelor’s Degree in Science, Engineering or equivalent technical discipline is required.
A minimum of 4 years relevant work experience is required. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy.
Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue Practices.
Great attention to detail and ability to follow the procedures.
The candidate must be highly organized and capable of working in a team environment with a positive attitude under minimal supervision.
Good written and verbal communication skills are required.
Ability to summarize and present results, and experience with team‑based collaborations is a must.
Must be able to interpret problems and effectively determine appropriate resolutions that ensure compliance and minimize risk.
Must exhibit strong leadership skills and effectively develop others.
Ability to collaborate well with stakeholders, customers and peers.
Must exhibit strong decision‑making ability and think creatively while maintaining compliance and quality.
Must be able to discern the criticality of issues and to communicate to management regarding complex issues.
Ability to manage conflict and issues that arise with internal or external customers.
Benefits and Pay Base pay range: $81,273 – $106,669 USD.
Other Types of Pay: Performance‑based bonus and/or equity is available to employees in eligible roles.
Benefits and Paid Time Off: Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. Eight (8) weeks of paid parental leave after three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short‑and‑long‑term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. Voluntary commuter benefits, family planning and care resources, well‑being initiatives, and peer‑to‑peer recognition programs are also offered.
Please note: These benefits are offered exclusively to permanent full‑time employees. Contractors are not eligible for benefits through Legend Biotech.
EEO Statement It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.
Employment is at‑will and may be terminated at any time with or without cause or notice by the employee or the company.
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