What are the responsibilities and job description for the Hybrid- QA Specialist II position at Actalent?
Seeking 1 QA Specialist II
Hybrid: on-site 2 days a week in Morris Plains, NJ
Description:
Will help from a leadership standpoint with regards to communication, reporting on team performance and mentoring / training.
•Performs a wide variety of activities to ensure compliance with applicable SOPs, documentation requirements, and / or regulatory requirements.
•Participates in developing Standard Operating Procedures to ensure quality objectives are met.
•Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs)
•Reviews routine manufacturing, environmental monitoring and quality control data for in-process and finished products.
•Develops solutions to more complex problems and identifies deviations from accepted practice and evaluates impact assessment as required.
•Maintains day-to-day communication with the CMOs to ensure deviations, change controls, batch records, and other GMP/GDP documentation is forward processed and closed out in a timely manner.
•Ensure that batch records are reviewed and released in a timely manner to maintain adequate MOH levels.
•Participates in the writing of annual product reviews.
•Interfaces with contract manufacturers to address documentation and compliance issues.
•Demonstrates thorough knowledge of FDA/EMEA standards and quality systems, and the interface with other functions like manufacturing, distribution and maintenance.
•Review, comment and work to resolve / close CMO deviations. Co-review Major and Critical CMO deviations with QFSL; as well as support / drive corrective and preventive action (CAPA) recommendations related to such events.
•Demonstrates audit and investigation skills, and report writing skills.
•Demonstrates strong verbal, technical writing and interpersonal skills.
•Review of CMO process validation executed protocol and report
•Taken on other tasks as needed.
Skills:
Batch Record Review, Deviations, GMP
Additional Skills & Qualifications:
•BS or BA in scientific discipline
•Minimum of 5 years of relevant experience
•Biologics experience is a must
•Experience in commercial manufacturing (fill finish preferred)
•Experience with batch record review and investigations required
Experience Level:
Intermediate Level
About Actalent:
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Salary : $35 - $45
