Quality Assurance Manager
4 days ago
Overview
Make your application after reading the following skill and qualification requirements for this position.
SOFIE is committed to all aspects of Quality and Compliance in the manufacture of Radiopharmaceutical products. This role provides Quality leadership to defined SOFIE facilities (and the network). SOFIE aseptically manufactures therapeutic and diagnostic radiopharmaceuticals across the US. The successful candidate will play an active and integral part of the Quality team supporting compliance and improvement for an assigned SOFIE facility (or facilities). The applicant will be responsible for the Quality Management System (QMS) at the given SOFIE facility (or facilities) and manage the site Quality Assurance Specialist(s). The candidate must be strong at technical and quality writing, root cause analysis, identifying trends, and establishing and implementing robust corrective and preventive actions. The candidate must also be able to learn technical, scientific, and quality processes to aid in the oversight of SOFIE and Partner drug products.
Essential Duties and Responsibilities
Ensure compliance to all applicable standard operation procedures (SOPs) and regulations, including 21 CFR Part 211 and 212 requirements, by implementing an effective and efficient quality management system and maintaining a state of cGMP control for sites within a given region.
Provide Quality Leadership to develop, maintain, and continually improve the Quality Management System (QMS).
Oversee all quality-related activities of routine radiopharmaceutical manufacture and directly supervise site-level Quality Assurance Specialists within a given facility or facilities.
Release clinical and commercial finished product batches, final drug product labels, reagents, manufacturing batch records, associated EM data, QC analytical testing results, and Certification of Analysis for conformance to SOPs, specifications, regulations, and other applicable acceptance criteria to ensure compliance and product quality as required.
Review, edit, and approve Change Control, Deviation, OOS investigation, and CAPA for sites. Closely track and follow up on these activities for timely closure. Ensure that scientifically sound investigations are conducted and root causes are identified. Initiate and implement CAPA plans. Evaluate the effectiveness of the CAPA plans through reporting and trending.
Author, review, and approve cGMP documents, including various procedures, protocols, specifications, reports, records, and changes to these documents.
Monitor and oversee the ongoing training program to qualify the site QASs to follow SOPs to perform their job functions at all times. Ensure the training covers any newly released procedures, revised procedures, and cGMP updates. Track individuals’ training requirements and ensure all trainings are on time and documented.
Ensure aseptic operations are in compliance with internal procedures (gowning, cleaning/sanitation, sterility, environmental monitoring, etc.), customer requirements, and FDA regulations for sites within a given site. Assure completeness, accuracy, traceability, and compliance of the site’s utility and facility monitoring methods and records.
Monitor the metrology program for given site(s). Ensure that all equipment is appropriately maintained, calibrated/recalibrated, or validated/revalidated in a timely manner. Ensure a comprehensive tracking system is implemented and followed.
Ensure that raw materials, components, containers, closures, packaging, and labeling are inspected, qualified, and meet acceptance criteria before use for sites within a given region. Ensure all materials are properly organized, controlled, and secured.
Provide QA oversight of manufacturing, QC, and other cGMP activities for sites within a given region. Identify non- compliance problems and propose solutions as appropriate. Effectively interact with other functional personnel at the site-level and resolve quality related issues.
Regularly conduct internal self-audit for quality management system effectiveness for sites within a given region. Document the findings in a self-audit report. Initiate action plans to prevent cGMP non-compliance and product quality problems proactively. Ensure continuous and sustained improvements.
Liaise with corporate QA audits, customer audits, and regulatory agency audits. Perform readiness assessment
Other responsibilities as required.
The description provided above is not intended to be an exhaustive list of all job duties, responsibilities, and requirements. Duties, responsibilities, and requirements may change over time and according to business need.
Qualifications
Bachelor’s Degree required (science, technical, or quality degree preferred)
4+ years of work experience in Quality Assurance in a cGMP pharmaceutical and/or biological manufacturing regulated environment.
2+ years’ supervisory experience within a Quality Assurance or Quality Control function.
Experience leading internal audits preferred.
Knowledge of USP, FDA, and cGMP regulations preferred.
Excellent analytical, prioritization, multi-tasking, communication, strong leadership skills, and the ability to work independently with limited supervision required.
Ability to effectively communicate (written and verbal) with site personnel, corporate QA, customers, and regulatory agencies required.
Ability to prepare and present written and verbal reports to upper management required.
Experience and/or full knowledge of manufacturing operations, preparation of sterile injectables, aseptic processing, and distribution of aseptic products preferred.
Knowledge of how and ability to write, review, and revise exception reports and SOPs required.
Ability to read, analyze, and interpret governmental regulations, general business periodicals, professional journals, or technical procedures required.
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals required.
Ability to write reports, business correspondences, and procedure manuals required.
Ability to effectively present information, deliver training, and respond to questions from groups of colleagues, managers, partners, and customers required.
Ability to define problems, collect data, establish facts and draw valid conclusions required.
Ability to solve problems and handle issues required.
Proficient in MS Office applications required.
Travel: up to 40% domestically.
#J-18808-Ljbffr
-
Quality Assurance Manager
4 days ago
Los Angeles, United States Captek Softgel International Full timeBecome part of a team that champions wellness worldwide! CAPTEK Softgel International is a global leader in the development and production of high-quality nutraceutical supplements. As a contract manufacturer organization (CMO), we collaborate with innovators from some of the world’s most successful brands. Summary: Quality Assurance Manager is responsible...
-
Quality Assurance Manager
1 month ago
Los Angeles, United States Meet Full timeMeet's partenered with a growing biotech in the SF Bay Area on an exciting new search for a talented Quality Assurance Manager! You'll be responsible for a variety of quality assurance operational activities related to product quality and compliance to manufacturing, testing, control, validation, and release of drug products and drug substances for...
-
Quality Assurance Manager
3 weeks ago
Los Angeles, United States Meet Full timeMeet's partenered with a growing biotech in the SF Bay Area on an exciting new search for a talented Quality Assurance Manager! You'll be responsible for a variety of quality assurance operational activities related to product quality and compliance to manufacturing, testing, control, validation, and release of drug products and drug substances for...
-
Quality Assurance Manager
1 month ago
Los Angeles, United States Special Service for Groups, Inc- HOPICS Full timesPECIAL sERVICE FOR gROUPS, INC.jOB ANNOUNCEMENTTitle: Quality Assurance Manager Division: HOPICSFLSA: Non-Exempt, Full Time Supervisor: Associate Director for Contracts, Compliance and PerformancePay Range or Rate: $ 25.00/hr. - $28.00/hr Revised: 4/25/2024SummaryUnder the direction of the Associate Director for Contracts, Compliance and Performance, the...
-
Quality Assurance Manager
4 weeks ago
Los Angeles, United States Special Service for Groups, Inc- HOPICS Full timeJob DescriptionJob DescriptionsPECIAL sERVICE FOR gROUPS, INC.jOB ANNOUNCEMENTTitle: Quality Assurance Manager Division: HOPICSFLSA: Non-Exempt, Full Time Supervisor: Associate Director for Contracts, Compliance and...
-
Quality Assurance Manager
1 month ago
Los Angeles, United States Special Service for Groups, Inc- HOPICS Full timeJob DescriptionJob DescriptionsPECIAL sERVICE FOR gROUPS, INC.jOB ANNOUNCEMENTTitle: Quality Assurance Manager Division: HOPICSFLSA: Non-Exempt, Full Time Supervisor: Associate Director for Contracts, Compliance and...
-
Quality Assurance Manager
2 weeks ago
Los Angeles, United States Juanitas Foods Full timeJob Description Job Description Description: Job Summary: Under the guidance and direction of the Director of Quality Assurance, the Quality Manager will implement Food Safety & Quality Assurance programs to ensure compliance of products and processes to corporate and regulatory requirements. The incumbent will also be responsible for overseeing HACCP, SQF,...
-
Quality Assurance Manager
2 weeks ago
Los Angeles, United States Hero Home Health Inc. Full time**Clinical Records Quality Assurance Specialist** The primary duties for the Clinical Records Quality Assurance Specialist are medical records and quality assurance/utilization review, audit preparation, intake assistance, and serving as a resource for clinical staff around charting, billing, and eligibility. The Clinical Records Quality Assurance...
-
Quality Assurance Manager
3 weeks ago
Los Angeles, United States Juanita's Foods Full timeJob DescriptionJob DescriptionDescription:Job Summary:Under the guidance and direction of the Director of Quality Assurance, the Quality Manager will implement Food Safety & Quality Assurance programs to ensure compliance of products and processes to corporate and regulatory requirements. The incumbent will also be responsible for overseeing HACCP, SQF, FDA,...
-
Quality Assurance Manager
4 weeks ago
Los Angeles, United States HEICO Full timeJob Description AeroAntenna Technology Inc. is looking for an experienced hands-on Quality Manager to join our Quality team. Salary- $105,000 per year Requirements Duties and Responsibilities Hire, manage, and train personnel to meet highest quality and reliability standards. Maintain AS9100 and ISO17025 certifications. Collaborate with management and line...
-
Plant Quality Assurance Manager
4 weeks ago
Los Angeles, California, United States Michael Page Full timeAbout Our Client My client is a fast growing company within the food manufacturing industry. They package and distribute their frozen products to customers globally. Job Description The responsibilities of the QA Mananger areDevelop, implement, and maintain quality assurance policies and procedures to ensure the production of safe and high-quality dairy...
-
Plant Quality Assurance Manager
1 month ago
Los Angeles, California, United States Michael Page Full timeAbout Our Client My client is a fast growing company within the food manufacturing industry. They package and distribute their frozen products to customers globally. Job Description The responsibilities of the QA Mananger areDevelop, implement, and maintain quality assurance policies and procedures to ensure the production of safe and high-quality dairy...
-
Quality Assurance Manager
2 weeks ago
Los Angeles, United States Amtec Direct Hire Full timeJob Description Job Description Quality Assurance Manager Sylmar, CA Direct hire Salary: $60,000 to $90,000 annual salary Leading company in the Aerospace industry in Sylmar area. We are hiring an experienced QA Manager to help us keep growing. If you're dedicated and ambitious then we are an excellent place to grow your career. Qualifications Experience at...
-
Quality Assurance Manager
4 weeks ago
Los Angeles, United States Amtec Direct Hire Full timeJob DescriptionJob DescriptionQuality Assurance ManagerSylmar, CADirect hireSalary: $60,000 to $90,000 annual salaryLeading company in the Aerospace industry in Sylmar area. We are hiring an experienced QA Manager to help us keep growing. If you're dedicated and ambitious then we are an excellent place to grow your career. Qualifications Experience at...
-
Quality Assurance Manager
4 weeks ago
Los Angeles, United States Amtec Direct Hire Full timeJob DescriptionJob DescriptionQuality Assurance ManagerSylmar, CADirect hireSalary: $60,000 to $90,000 annual salaryLeading company in the Aerospace industry in Sylmar area. We are hiring an experienced QA Manager to help us keep growing. If you're dedicated and ambitious then we are an excellent place to grow your career. Qualifications Experience at...
-
Quality Assurance Specialist
2 months ago
Los Angeles, United States Crystal Stairs Full timeWhat We're Looking For : Crystal Stairs is seeking a Quality Assurance Specialist for our Quality Assurance Unit. Under general supervision, the Quality Assurance Specialist is responsible for monitoring program compliance by conducting quality assurance reviews of client and provider files, providing feedback to program managers, and recommending process...
-
Quality Assurance Specialist
4 weeks ago
Los Angeles, United States Crystal Stairs Full timeWhat We're Looking For : Crystal Stairs is seeking a Quality Assurance Specialist for our Quality Assurance Unit. Under general supervision, the Quality Assurance Specialist is responsible for monitoring program compliance by conducting quality assurance reviews of client and provider files, providing feedback to program managers, and recommending process...
-
Clinical Quality Assurance Manager
1 month ago
Los Angeles, United States Barrington James Full timeJob Responsibilities You will collect site metrics for selection of investigator site audits. As the Clinical QA Manager, you will be responsible for implementation and update of investigator site audit plans You will be responsible for developing and maintaining clinical quality study risk plans and maintain updates in Quality Management System Assist in...
-
Clinical Quality Assurance Manager
4 weeks ago
Los Angeles, United States Barrington James Full timeJob Responsibilities You will collect site metrics for selection of investigator site audits. As the Clinical QA Manager, you will be responsible for implementation and update of investigator site audit plans You will be responsible for developing and maintaining clinical quality study risk plans and maintain updates in Quality Management System Assist in...
-
Quality Assurance Specialist
1 month ago
Los Angeles, United States Special Service for Groups, Inc- HOPICS Full timeJob DescriptionJob DescriptionTitle: Quality Assurance Specialist Division: HOPICS FLSA: Non-Exempt, Full time ...
