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Description:
-works closely with manufacturing regarding product quality planning, design, and improvement to ensure quality is built into manufacturing processes.-Supports Internal audits and external vendor audits including leading audits and providing the required reports and documentation.- Performs change control assessments to Quality Systems including document management, change control, and CAPA.- Approves deviations and CAPAs to ensure all deviations/change controls from establish procedures are appropriately documented and investigated to determine and address the root cause.- Acts as Quality Subject Matter Expert and represents Quality in internal and vendor meetings- Collaborates with manufacturing, clinical, and regulatory groups to ensure site quality.- manages the QA review of Batch Records- Manages the SOP review processes and assist in identifying gaps.- Communicates changes in regulations and practices to the organization in a effective timely manner, and aids the development of plans to address these changes. - Interacts with Regulatory Affairs, and Manufacturing to ensure that regulatory submissions meet domestic and international standards and regulatory requirements.
Skills:
Capa, change control, deviations, Batch record, Quality assurance, Audit, Gmp, Cgmp, Batch record review, Document control
Top Skills Details:
Capa,change control,deviations,Batch record,Quality assurance
Additional Skills & Qualifications:
- Bachelors degree in scientific discipline- Minimum of 5 years of quality assurance experience- Minimum of 3 years of experience in a Quality Assurance management role. - Demonstrated mastery/understanding of quality systems and quality controls- detailed working knowledge of cGxP requirements and current FDA regulations- Experience in preparation of IND and BLA applications
Experience Level:
Intermediate Level
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
