Sr Quality Assurance Specialist jobs in United States
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US WorldMeds · 5 hours ago

Sr Quality Assurance Specialist

positionPhiladelphia, PA
timeFull-time
remoteOnsite
senioritySenior Level
date5+ years exp

US WorldMeds is a biopharmaceutical company focused on developing innovative therapies. The Senior Quality Assurance Specialist will support quality functions and ensure compliance with GMP standards while liaising with various teams to maintain product quality.

Health CarePharmaceutical
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Comp. & Benefits
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H1B Sponsor Likelynote

Responsibilities

Conduct record review of executed batch records, QC testing data, and associated batch file documentation to ensure timely disposition of patient lots
Perform disposition of lentiviral vector and finished drug product batches
Liaise with external CMO and contract Qualified Persons in support of manufacture and release of lentiviral vector or T-cell drug product for US, EU and UK use
Performs line/room clearance to support manufacturing activities in aseptic suites
Print, issue and reconcile production labels, QC labels and final product labels
Inspect, review and release raw materials and consumables for GMP use
Provide QA oversight of incoming and outgoing shipments of apheresis, lentiviral vector, or finished T-cell drug product
Manage Deviation, CAPA or Change Control records related to Quality Assurance operations
Create or revise Quality SOPs
Occasional weekend work required
Other responsibilities as required

Qualification

GMP complianceBatch record reviewAseptic processingQuality SystemsBiopharmaceutical experienceFDA/EMA regulationsAnalytical skillsInterpersonal skillsProblem solvingTeamwork

Required

Bachelor's Degree in a scientific discipline
Minimum of 5 years in a global biopharmaceutical or biological manufacturing environment with exposure to Quality GMP operations
Direct experience with review and approval of batch records and QC testing data
Knowledge of aseptic processing and aseptic gowning techniques
Broad knowledge of GMP, ICH and FDA/EMA regulations
Broad knowledge of Quality Systems, such as Change Control, Investigations, and CAPA
Ability to work on assigned projects independently with limited supervision

Company

US WorldMeds

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US WorldMeds is a closely-held, Kentucky-based specialty pharmaceutical company. Our mission is to develop, license and commercialize
dateFounded in 2001
location
Louisville, Kentucky, USA
people-size51-200 employees
web-link
http://www.usworldmeds.com

H1B Sponsorship

US WorldMeds has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (1)
2020 (6)

Funding

Current Stage
Growth Stage
Total Funding
$15M
Key Investors
National Institute on Drug Abuse (NIDA)
2016-07-01Series Unknown
2013-06-18Grant· $15M
2006-11-13Seed

Leadership Team

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H Lee Warren
Chief Operating Officer
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