Sumitomo Pharma Co., Ltd
Quality Assurance Specialist II
Morrisville, NC · Mid
Sponsorship not specified$85k-$106kDetected 1 day ago
AccessibilitySAPERPRecruitingGMPFDA RegulatoryResearchLeadershipCommunicationAdaptability
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26Unrated
Cap-exempt (no lottery)0
Sponsors this role0
Entry-level history0
PERM / green-card track0
Lottery odds (Level II)66
Fits your clock70
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About the role
- With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner.
- For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn.
- The Quality team at Sumitomo Pharma America, Inc. takes pride in leading compliant and innovative approaches to the development and commercialization of life-saving therapies.
Responsibilities
- Lead or participate in investigations and improvement activities and experience using tools, such as
- Review and verify maintenance and calibration records in BMRAM and collaborate with engineering and maintenance teams to resolve discrepancies.
- Ensure a state of inspection readiness at our internal manufacturing facility; provide Quality support and audit management during Agency inspections.
- Support the SMPA Quality Management System, including but not limited to processes for Document Management, Deviations, CAPA, Change Control, Complaints, Management Review, Validation and Data Integrity.
- Flexibility to support off-
- Experience in a cGMP manufacturing environment, with strong working knowledge of FDA requirements and guidance documents.
Requirements
- Must be able to exercise appropriate judgment as necessary.
- Excellent written and oral communication skills required.
- Requires ability to use a personal computer for extended periods of time.
- Must be able to travel domestically and internationally as needed.
- Applicants for sales/field, manufacturing, or other designated roles will be required to submit to a pre-employment drug test.
- Must be able to pass cleanroom gowning and aseptic technique qualification.
- High degree of organizational awareness, ability to connect the dots to understand interdependencies.
- B.S. in chemistry, biological or pharmaceutical sciences, or related discipline is required.
- Experience with isolator and BCS operations
Compensation
- The base salary range for this role is
Equal opportunity
- Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer
- This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.
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