![BioSpace, Inc.](https://media.trabajo.org/img/noimg.jpg)
Manager, QA Operations
1 month ago
At AstraZeneca's Oncology R&D division, we follow the science to explore and innovate. We are working towards treating, preventing, modifying, and even curing some of the world's most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world. We are committed to making a difference and have built our business around our passion for science. Now we are fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs.
Position Summary
The Manager, QA Operations ensures compliance with the quality system's procedures and assessing regulatory and quality risks in activities and processes according to regulatory agency guidelines and company practices. This role is accountable for routine Quality Assurance duties related to the production and disposition of products manufactured and tested on behalf of Neogene. This role is based in Santa Monica, CA, and reports to the Director of Quality.
Responsibilities
Provide quality assurance support across departments (Manufacturing, Supply Chain, QC, Process Development, Regulatory Affairs) within Neogene and externally to assure compliance and relationships.
Perform several activities to ensure compliance with applicable quality goals and regulatory requirements.
Batch documentation ensure resolution of issues to release product.
Approval of Deviations and CAPAs Support Disposition of product for U.S. and other countries.
Support New Product Introductions.
Support quality assessments of internal operations to analyze quality compliance and assess risk.
Provide QA guidance on product development projects and technical transfer activities
Support Management Review activities and oversee trending of important quality, product and GMP metrics.
Support regulatory inspections, internal audits, and external audits from partners.
Develop QA Standard Operating Procedures to ensure Quality goals are met
Review routine manufacturing and quality control data for in-process and finished product.
Develop solutions to more complex problems.
May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products.
Education And Experience
Bachelor's degree with a minimum seven (7) years of experience OR Master's Degree and a minimum five (5) years of experience OR PhD with a minimum of two(2) years experience in a GMP environment.
Knowledge of and ability to apply GMP in conformance to US, EU and ROW standards.
Proficient in cGMP regulations, quality systems and regulatory requirements.
Experience writing, evaluating and closing investigations, CAPAs and change control records.
Experience conducting internal and external audits.
Willing to accept temporary responsibilities outside of initial job description.
Ability build collaboration amongst individuals.
Proficient in MS Word, Excel, Power Point and other applications.
Willingness to think outside of the box and adapt best practices for stage appropriate products.
Demonstrate organizational, prioritization, and proficiency.
When we put unexpected teams in the same room, we fuel bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
The annual base salary for this position ranges from $94,719 to $118,399. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related experience. If hired, employee will be in an "at-will position" and we reserve the right to modify base salary (and any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
Benefits
Short-term incentive bonus opportunity
Equity-based long-term incentive program
401(k) plan
Paid vacation and holidays; paid leaves
Health benefits including medical, prescription drug, dental, and vision coverage.
DE&I Statement
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
#J-18808-Ljbffr
-
Manager, QA Operations
1 month ago
Santa Monica, United States Neogene Therapeutics Full timeAt AstraZeneca's Oncology R&D division, we follow the science to explore and innovate. We are working towards treating, preventing, modifying, and even curing some of the world's most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world. We are committed to making a...
-
Manager, QA Operations
1 month ago
Santa Monica, United States Neogene Therapeutics Full timeAt AstraZeneca's Oncology R&D division, we follow the science to explore and innovate. We are working towards treating, preventing, modifying, and even curing some of the world's most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world. We are committed to making a...
-
QA Specialist
2 weeks ago
Santa Monica, United States Onward Play Full timeOur client, a Video Game Studio, is seeking a QA Specialist to join its team! The QA Specialist will be delivering accuracy on key data tracking details supporting analysis and insight functions such as logic building, reporting, dashboards, a/b tests and other analytics deliverables. This role plays a critical role in reducing our time to useful data, and...
-
QA Specialist
2 weeks ago
Santa Monica, United States Onward Play Full timeOur client, a Video Game Studio, is seeking a QA Specialist to join its team! The QA Specialist will be delivering accuracy on key data tracking details supporting analysis and insight functions such as logic building, reporting, dashboards, a/b tests and other analytics deliverables. This role plays a critical role in reducing our time to useful data, and...
-
QA Engineer
2 months ago
Santa Monica, United States Kixie Full timeAs a QA Engineer at Kixie, you will be responsible for: - Collaborating with cross-functional teams, including developers, product managers, and designers, to understand software requirements and design test plans. - Developing and executing comprehensive test cases, scripts, and plans to thoroughly validate software functionality, performance, and...
-
Business Analyst/QA Analyst
1 day ago
Santa Monica, United States 1872 Consulting Full timeBusiness Analyst/Quality Assurance Analyst Los Angeles or Pittsburgh office - Hybrid onsite 2-3 days per week Team Description We are a small team supporting a large set of systems including numerous websites, contact management, email outreach, mobile applications, publishing systems, process management, and analytics, as well as our internal systems...
-
QA Manager
7 days ago
Santa Fe, United States ConglomerateIT LLC Full timeJob DescriptionJob DescriptionKey Responsibilities:Develop and implement quality assurance strategies and procedures.Lead and manage the QA team, providing guidance and support.Design and execute test plans, test cases, and test scripts for various software applications.Coordinate with development teams to understand project requirements and ensure quality...
-
Operations Supervisor
4 weeks ago
Santa Monica, United States Veo - Operations Careers Full timeThis is a W2 full-time position Company Overview: At Veo, we are on a mission to end car dependency by making clean transportation accessible to all and advancing the next generation of fully electric micromobility systems. Our fleets are constantly evolving and feature a range of vehicles - from pedal and electric bicycles, to standing and seated...
-
Operations Supervisor
1 month ago
Santa Monica, United States Veo - Operations Careers Full timeThis is a W2 full-time position Range: $25 Company Overview: At Veo, we are on a mission to end car dependency by making clean transportation accessible to all and advancing the next generation of fully electric micromobility systems. Our fleets are constantly evolving and feature a range of vehicles - from pedal and electric bicycles, to standing and...
-
QA Manager
2 months ago
Santa Barbara, United States Ontraport Full timeJOB DETAILS Overview As a Manager in the Engineering Department, you will focus on employee training, team reporting and process management. In addition, you will demonstrate what is expected as a senior on your team, while following management best practices. In addition, You will work closely with the entire Management team to create a healthy and...
-
Quality Assurance Manager
2 months ago
Santa Monica, United States High-Tech Professionals Full timeQuality Assurance Manager Job ID: 1599 Location: Santa Monica, CA Type: Permanent Status: Closed Key Skills: Test plans, tracking, Bitten, Tinderbox, CI framework, Python, unit testing, TRAC or JIRA, Selenium Description: Technology company with significant brand leverage is seeking Quality Assurance Manager who will guarantee that company's software works...
-
Project Manager/ QA Lead
3 weeks ago
Santa Fe Springs, United States Invictus Talent Solutions Full timeFull Time Project Manager/QA Lead We are looking for a highly motivated and experienced Project Manager/QA Lead to join our team. The ideal candidate will have a strong understanding of the aerospace industry and be proficient in CAD software, AS9100, and other quality management systems. The primary responsibility of the Project Manager/QA Lead will be to...
-
QA Engineer
2 months ago
Santa Clara, United States NVIDIA Full timeNVIDIA has been redefining computer graphics, PC gaming, and accelerated computing for more than 25 years. Its a unique legacy of innovation thats fueled by great technologyand amazing people. Today, were tapping into the unlimited potential of AI to define the next era of computing. An era in which our GPU acts as the brains of computers, robots, and...
-
QA Audit Supervisor
2 months ago
Santa Ana, United States Fujifilm Holdings Corp Full timePlan, budget, coordinate auditors to ensure audit program is completed. Manage and perform internal and supplier audits (on-site and paper) as needed. Manage and performs supplier qualification and re-evaluation. Manage maintenance of supplier files Audit, QA, Supervisor, Medical, Manufacturing, Technology
-
Senior Product Manager, Location Management
1 month ago
Santa Monica, California, United States Metropolis Technologies Full timeLocation: Santa Monica, CA or New York City, NY (Hybrid) The CompanyMetropolis is an artificial intelligence company that uses computer vision technology to enable frictionless, checkout-free experiences in the real world. Today, we are reimagining parking to enable millions of consumers to just "drive in and drive out." We envision a future where people...
-
Laboratory Operation support specialist
2 days ago
Santa Monica, United States Intelliswift Software Full timeTitle: Laboratory Operation support specialist Location: On-site Santa Monica, CA. Hours/Days: (Tuesday-Sat) Flexible hours. Duration: 06 Months assignmentResponsibilities• Perform QC sample receipt, processing and distribution for testing and storage• Perform Apheresis Accession, Inspection, and assist QA with product returns• Maintain, operate...
-
Laboratory Operation support specialist
2 days ago
Santa Monica, United States Intelliswift Software Full timeTitle: Laboratory Operation support specialist Location: On-site Santa Monica, CA. Hours/Days: (Tuesday-Sat) Flexible hours. Duration: 06 Months assignmentResponsibilities• Perform QC sample receipt, processing and distribution for testing and storage• Perform Apheresis Accession, Inspection, and assist QA with product returns• Maintain, operate...
-
Lab Operations Specialist I
3 days ago
Santa Monica, United States Planet Pharma Full time(This is an onsite 6-month contract, with potential to extend/convert, available to people local to the Santa Monica, CA area)Pay Rate Range: $24-28/hr. Salary will be commensurate with experienceSchedule: Tuesday-Saturday (Flexible hours)Our client cannot accept any C2C or candidates who requires sponsorship now or at any point in the future (this includes...
-
Lab Operations Specialist I
3 days ago
Santa Monica, United States Planet Pharma Full time(This is an onsite 6-month contract, with potential to extend/convert, available to people local to the Santa Monica, CA area)Pay Rate Range: $24-28/hr. Salary will be commensurate with experienceSchedule: Tuesday-Saturday (Flexible hours)Our client cannot accept any C2C or candidates who requires sponsorship now or at any point in the future (this includes...
-
QA CAPA Manager
2 months ago
Santa Barbara, United States KARL STORZ SE & Co. KG Full timeEvery day our products and services help to save lives around the globe. Therefore, we make quality and reliability our number one priority. Get to know us and join our team as QA CAPA Manager Job Function: Patient Health & Regulatory Affairs Location: Goleta, CA, US, 93117 Stafford, TX, US, 77477 Charlton, MA, US, 01507 Work Flexibility: Onsite (Office/...