- Collaborate across departments to ensure that the site's quality system
- Partner with validation and engineering teams to oversee quality during
- Stay updated on local and international regulatory requirements and trends,
- Work cross-functionally to develop and implement processes effectively.
- Ensure compliance during product and process transfers between
- Provide support for overall facility, equipment, and manufacturing process
- Support quality processes throughout the product lifecycle, including
- Review and support calibration and maintenance programs to ensure GMP
- Lead or participate in deviation investigations and quality risk analyses.
- Proactively identify and resolve problems using functional and technical
- Advocate for a quality-focused approach in all activities and operations.
- Prioritize safety in all operations and activities.
- Some travel (up to 10%) may be necessary.
- A Bachelor's degree in a scientific field with at least 7 years of
- Proficiency in facility and equipment qualification, process validation,
- Familiarity with 21CFR Part 11, Electronic Records and Signatures, and a
- Strong project management skills, organizational abilities, and a knack for
- Involvement in and leadership of activities to support regulatory agency
- Self-driven, adaptable, and comfortable working in a small, fast-paced, and
- Ability to work independently while adhering to established guidelines,
- Acting as a Quality subject matter expert to facilitate thorough
- Leveraging personal experience and industry best practices to enhance
- Committed to delivering high-quality outcomes, collaborating with others to
- Actively seeking opportunities for learning, skill development, and
- Exceptional interpersonal and written communication skills, along with
- Experience spanning the product development and commercialization lifecycle.
- Technical proficiency in sterile pharmaceuticals.
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QA Engineer - Juneau, United States - The University of Texas MD Anderson Cancer Center
Description
Job Title:
QA Engineer
Job Number:
77882
Location:
Petersburg,US
Job Description
Key responsibilities of this role include overseeing quality systems to ensure
that the validation/qualification and operation of processes, facilities,
equipment, and computer systems meet cGMP and compliance standards. This
oversight begins with the facility's startup and continues until successful
approval by the FDA, including the ongoing introduction and approval of new
medications. Additionally, the role involves tasks such as generating,
reviewing, and/or approving policies, procedures, reports, and other
documentation essential for quality assurance. This includes validation,
qualification, and ongoing operational activities related to facility,
utilities, processes, equipment, and instrumentation, all aimed at ensuring
compliance with FDA requirements.
Responsibilities
and procedures.
throughout.
complaints, APQR, and management notifications.
priorities simultaneously.
Application Deadline:
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