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Quality Assurance
2 weeks ago
University of California San Francisco San Francisco, United StatesThe Quality Assurance (QA) Manager will oversee the activity of the quality assurance department and staff, developing, implementing, and maintaining a system of quality and reliability testing for the organization's products and/or development processes. QA deliverables and mana ...
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Quality Assurance Manager
1 week ago
Actalent San Mateo, United States Full timeDescription: · • Ensures site quality oversight of commercial and/or development products at CMO's. · • Oversees the commercial and/or development implementation of the Quality strategy for Gilead development portfolio of products and/or across quality sub functions. · • Partners ...
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Quality Assurance Manager
1 week ago
Actalent San Mateo, United States Full timeDescription: · • Ensures site quality oversight of commercial and/or development products at CMO's. · • Oversees the commercial and/or development implementation of the Quality strategy for Gilead development portfolio of products and/or across quality subfunctions. · • Partners ...
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Quality Assurance Specialist
4 days ago
Actalent San Mateo, United States Full timeDescription: · Role and Responsibilities: · • Review and approve master batch records, labels, specifications and other pre-production documents for Clinical/Commercial Drug Product in compliance with FDA and international health agency requirements. · • Review executed productio ...
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Quality Assurance Specialist
1 week ago
Actalent San Mateo, United States Full timeDescription: · 20% BRR · 80% Analytical focused · • Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements · • Serves as QA Lead for clinical and commercial projects. · • Leads quality investigations/deviations/ ...
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Quality Assurance Specialist
1 week ago
Actalent San Mateo, United States Full timeQuality Assurance Specialist · HYBRID role, onsite in Foster City, CA · Description: · ● Receives product complaints for products from the US and Canadian markets. · Documents in Quality System for investigation for product complaints and triages safety events to Pharmacovigilanc ...
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Quality Assurance Specialist
1 week ago
Actalent San Mateo, United States Full timeDescription: · ● Receives product complaints for Gilead products from the US and Canadian markets.Documents in Gilead Quality System for investigation for product complaints and triages safety events to Gilead Pharmacovigilance Department. Performs or provides support for product ...
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Quality Assurance Specialist
6 days ago
Actalent San Mateo, United States Full timeDescription: · ● Receives product complaints for products from the US and Canadian markets. · Documents in Quality System for investigation for product complaints and triages safety events to Pharmacovigilance Department. Performs or provides support for product complaint investi ...
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Quality Assurance Specialist
3 days ago
Actalent San Mateo, United States Full timeDescription: · • Receives product quality complaints (typically via phone or fax or email), from healthcare professionals and patients · • Documents all incoming complaints in to complaint management system timely and notifies other QA specialists for start of investigations · • ...
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Quality Assurance Specialist
1 week ago
Actalent San Mateo, United States Full timeDescription: · ● Receives product complaint from the US and Canadian markets. · Documents in Quality System for investigation for product complaints and triages safety events to the Pharmacovigilance Department. Performs or provides support for product complaint investigations · ...
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Quality Assurance Specialist
1 week ago
Actalent San Mateo, United States Full timeDescription: · ● Receives product complaints for products from the US and Canadian markets. · Documents in Quality System for investigation for product complaints and triages safety events to Pharmacovigilance Department. · Performs or provides support for product complaint inve ...
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Quality Assurance Manager
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Lumenous Device Technologies Santa Clara, United States**Lumenous is Hiring** · Lumenous Device Technologies is at the forefront of medical device manufacturing for ultraprecision medical components for interventional catheters, implants, robotic surgery, and a wide variety of components used in mínimally invasive medical devices thr ...
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Quality Assurance Manager
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Bayview Hunters Point Foundation for Community Imp San Francisco, United States**What We Do**: · Bayview Hunters Point Foundation has been at the heart of social justice for over 50 years, providing support services for predominantly low-income people of color in the Bayview and throughout San Francisco. · Our mission is to build a community that is empower ...
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Manager, Quality Assurance
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Cutera Brisbane, United States**Company Description** · We're Growing - With Growth Comes Opportunity · **Job Description** Position Summary**: · The individual is responsible for activities that lead to, and maintain compliance to/with Cutera's Quality Management System and maintains regulatory approval to m ...
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Quality Assurance Engineer
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SLAC National Accelerator Laboratory Menlo Park, United StatesQuality Assurance Engineer · Job ID · 5902 · Location · SLAC - Menlo Park, CA · Full-Time · Regular · SLAC Job Postings · Position Overview: · SLAC Contractor & Quality Assurance group is seeking a Quality Assurance Engineer (QAE). The primary purpose of the Quality Assu ...
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Head of Quality Assurance
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Oruka Tx Menlo Park, United StatesAbout Us: Oruka Therapeutics is a newly launched company whose mission is to restore skin health. We were founded by well-known investors at Fairmount Funds, in the same model as Apogee Therapeutics and Spyre Therapeutics which together have raised $700M+ over the past two years ...
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Head of Quality Assurance
1 week ago
Oruka Tx Menlo Park, United StatesAbout Us: · Oruka Therapeutics is a newly launched company whose mission is to restore skin health. We were founded by well-known investors at Fairmount Funds, in the same model as Apogee Therapeutics and Spyre Therapeutics which together have raised $700M+ over the past two yea ...
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Quality Assurance Manager
5 days ago
SLAC National Accelerator Laboratory Menlo Park, United StatesQuality Assurance Manager · Job ID · 5681 · Location · SLAC - Menlo Park, CA · Full-Time · Regular · **SLAC Job Postings** · **Position Overview:** · The SLAC Quality Assurance Manager is responsible for providing leadership, vision, management, direction, oversight and strategic ...
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Quality Assurance Engineer
5 days ago
Vello Systems Menlo Park, United StatesResponsibilities Responsiblefor test design for a network solution incorporating virtualization, network management tools, and hardwarecomponents · Responsiblefor technical review of features for feasibility and design · Effectivelycommunicates or reinforces messages consistent ...
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Quality Assurance Technician
11 hours ago
Petit Pot Emeryville, United StatesAbout Petit Pot · In 2014, while trying to find the perfect dessert to go with dinner, French pastry chef Maxime realized something was missing in his local grocery store: Pot de crème As a fan of all things sweet, Maxime decided to address this craving by founding Petit Pot in S ...
Sr Manager, CMC Quality Assurance - Menlo Park, United States - Kaztronix
Description
Company is seeking aSenior Manager, CMC Quality Assurance,
to help lead quality for Company's Client oncology therapies.
The Senior Manager of CMC Quality Assurance will be responsible for building the CMC quality assurance processes and providing Quality oversight for the GMP activities throughout the development stages of antibody-based radiopharmaceuticals.
:
US$ 145K - $180K
Principal Responsibilities
Accountable for master batch records reviews, conduct and/or oversee in-process and final product lot release partnering with multiple CMOs through audits, and batch record and testing approvals.
Assist with the development, review and approval of quality system including Standard Operating Procedures (SOPs) required for molecularly targeted radiotherapy product manufacturing, packaging, and distribution.
Manages and oversees change controls, deviations/investigations, CAPAs, vendor qualification, customer complaints, stability studies, regulatory agency inspections, product recalls, and annual product review.
Supports Quality Management Review on the performance of the quality system, including periodic management reports, management review meetings, and other reviews and recommendations for system improvements.
Qualifications, Education & Experience
Minimum of a Bachelor's degree in life science or equivalent and 8+ years' experience in GXP and Quality Systems in biotechnology, antibody drug conjugated or molecularly targeted radio therapies.
In depth knowledge of regulations and guidance supporting phase appropriate cGMP to include FDA, EMA, ISO standards and ICH guidelines with direct impact to clinical programs.
Experience working effectively with CMOs
Skills and abilities
A solid understanding of GMPs and CMC requirements is expected.
Strong knowledge of Quality, Compliance, US & International cGxPs, regulations, product development and manufacturing.
Must be familiar with ICH regulations and FDA/EMA requirements and expectations, plus experience with health authority inspections.
Demonstrated thought leadership in CMC Quality Assurance.
Experience in preparing regulatory filings.
Strong interpersonal and collaboration skills.
Excellent verbal and written communication skills.
Ability to operate in a fast-paced, multi-disciplinary industrial environment.
Ability to critically evaluate and troubleshoot complex problems and attention to detail.
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws.
In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.
By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.#J-18808-Ljbffr
