- Review of executed manufacturing batch records for completeness, compliance, and accuracy to support product lot disposition.
- Review and approve logbook activities.
- Approve equipment and room change-over operations.
- Approve and execute area change-over operations.
- Support review and approval of Master Production Records (MPRs).
- Conduct review and approval of GMP documents (i.e. Standard Operating Procedures (SOPs), Forms, Work Instructions, etc.) in the electronic Document Management System.
- Support Deviations, CAPAs and Change Control, when required.
- Collaborate in the resolution of issues associated with the manufacturing operations, with the QA point-of-contact, to provide guidance and facilitate the resumption of manufacturing activities post deviation detection.
- This position is a Night Shift and will require to work 12-hour shifts to support Manufacturing, Quality Control, and Engineering Operations activities.
- Technical and analytical understanding of Biologics Manufacturing and testing.
- Knowledge of regulatory compliance principles, strategy, and rational as they relate to Biologics Manufacturing.
- Good oral and written communication skills.
- Good organizational skills.
- Demonstrated experience in areas of teamwork and problem-solving.
- Ability to work on moderately complex problems where analysis of situations or data requires an evaluation of factors.
- Understanding of basic scientific/technical concepts
- Bachelor's degree in Biology, Chemistry or other relevant science/engineering discipline or equivalent work experience.
- Previous experience in QA or related document control experience, as required below:
- Associate II - Minimum 2 years
- Associate III - Minimum 5 years
- Equivalent education and experience may substitute for stated requirements
-
Quality Assurance Associate I-III
2 weeks ago
AGC Biologics Boulder, United StatesOur purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients' lives by bringing new biopharmaceuticals to mark ...
-
Quality Assurance Associate II/III
2 weeks ago
AGC Biologics Longmont, United StatesOur purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients' lives by bringing new biopharmaceuticals to mark ...
-
Quality Assurance Associate II/III
1 week ago
AGC Biologics Longmont, United StatesOur purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients' lives by bringing new biopharmaceuticals to mark ...
-
Patient Care Associate
2 weeks ago
Boulder Community Health Boulder, United States Half timePatient Care Associate – Certified Nursing Assistant · Boulder Community Health, Boulder, CO 80303 · $ $24.75 an hour - Half time, Days. 24 hours a week. · Boulder Community Health is seeking a Patient Care Associate / Certified Nursing Assistant, where you will serve as a dedic ...
-
Patient Care Associate
3 weeks ago
Boulder Community Health Boulder, United States Half timePatient Care Associate – Certified Nursing Assistant · Boulder Community Health, Boulder, CO 80303 · $ $24.75 an hour - Half time, Days. 24 hours a week. · Boulder Community Health is seeking a Patient Care Associate / Certified Nursing Assistant, where you will serve as a dedic ...
-
Electronics Technician
2 weeks ago
BI Incorporated Boulder, United States Full timeBenefits Information · This job posting is anticipated to remain open until June 4th, 2024. · Full-time employees will enjoy a competitive benefits package with options for you and your family including: · • Paid Time Off · • Paid Holidays · • 401(k) Matching · • Health Insuran ...
-
Electronics Service
3 weeks ago
AllSTEM Connections Boulder, United StatesElectronics Service Technicians. Direct Hire. · Pay Rate: $26/hr. Excellent benefits package. · As a Service Technician, you'll be addressing our customer's equipment maintenance and repair needs. The position is tasked with assuring customer satisfaction through timely and effic ...
-
Senior iOS Engineer
1 week ago
Major League Baseball Boulder, United StatesOverview · Major League Baseball is looking for an experienced Senior Software Engineer to join our dynamic, fun, and challenging team. MLB is responsible for some of the most popular sports app in the world. Our Growth, Innovation, and Fan Engagement (GIF) team develops and deli ...
-
Information Systems Security Officer
2 weeks ago
Lockheed Martin Boulder, United States· Description:A Secret clearance is required to start with the ability to obtain Top Secret clearance. · The Cybersecurity Specialist will partner with the security team, program, and government customers to perform as an Information Systems Security Officer (ISSO) in Boulder, C ...
-
Merck Sharp & Dohme West Point, United StatesOur Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored, and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufact ...
-
Case Manager RN
4 weeks ago
UnitedHealth Group Boulder, United StatesOptum is a global organization that delivers care, aided by technology to help millions of people live healthier lives. The work you do with our team will directly improve health outcomes by connecting people with the care, pharmacy benefits, data and resources they need to feel ...
-
Project Engineer I
1 week ago
Cedent Consulting Boulder, United StatesTitle: · Project Engineer I - Mission Assurance @ Boulder, CO · Terms of Hire: Full time. · Job Responsibilities · Job description · Project Engineer I – Mission Assurance · Perform the project engineering and management required to execute the Mission Assurance (MA) baseline. ...
-
Project Engineer II
2 weeks ago
LAUNCH Technical Workforce Solutions Boulder, United StatesProject Engineer II - Mission AssuranceLAUNCH Technical Workforce Solutions is seeking an Project Engineer II - Mission Assurance for an opportunity in Boulder, CO.Job ResponsibilitiesPerform the project engineering and management required to execute the Mission Assurance (MA) ba ...
-
Product Cybersecurity Engineer
1 week ago
SciTec Boulder, United StatesSciTec has been awarded multiple government contracts and is growing our creative Team SciTec, Inc. is a dynamic small business with the mission to deliver advanced sensor data processing technologies and scientific instrumentation capabilities in support of National Security and ...
-
Product Cybersecurity Lead
2 weeks ago
Sports Technology Awards Group Boulder, United StatesSciTec has been awarded multiple government contracts and is growing our creative Team SciTec, Inc. is a dynamic small business with the mission to deliver advanced sensor data processing technologies and scientific instrumentation capabilities in support of National Security and ...
-
Product Cybersecurity Engineer
1 week ago
SciTec Boulder, CO, United StatesSciTec has been awarded multiple government contracts and is growing our creative Team SciTec, Inc. is a dynamic small business with the mission to deliver advanced sensor data processing technologies and scientific instrumentation capabilities in support of National Security and ...
-
Product Cybersecurity Engineer
19 hours ago
SciTec Boulder, United StatesJob Description · Job DescriptionSciTec has been awarded multiple government contracts and is growing our creative Team SciTec, Inc. is a dynamic small business with the mission to deliver advanced sensor data processing technologies and scientific instrumentation capabilities in ...
-
Top Secret Clearance
1 week ago
Dunson & Associates, Inc. Boulder, United StatesJob Description · Job DescriptionCyber Detection Engineer · Location: Boulder, CO · Clearance: Minimum fully adjudicated Secret and Interim Top Secret clearance · The Cyber Detection Engineer will develop detections based on intelligence available, then research and assist in · i ...
-
Sales Associate/Material Handler
1 week ago
Salvationarmytucson Boulder, United States** Sales Associate/Material Handler - Boulder, CO $12.32/hour Part - Time** · **Job Category****:** Thrift Stores - all positions **Requisition Number****:** SALES01901 Showing 1 location **Job Details** · **Description** · ESSENTIAL DUTIES AND RESPONSIBILITIES: · 1. Ensure C ...
-
Sr. Quality Assurance Specialist
2 weeks ago
Danaher Boulder, United States Full timeIntegrated DNA Technologies (IDT) is the leading manufacturer of custom oligonucleotides and proprietary technologies for genomics applications. Our work is complex and cutting-edge, and our team members are curious, creative thinkers who understand that good data drives smart de ...
Quality Assurance Associate, II - Boulder, United States - AGC Biologics
![Default job background](https://contents.bebee.com/public/img/bg-user-ex-1.jpg)
Description
Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients' lives by bringing new biopharmaceuticals to market.JOB SUMMARY
The Quality Assurance Associate II-III (In Plant Operations) is responsible for providing (24/7/365) Quality support to the activities listed below at the Boulder, CO site.
RESPONSIBILITIES
Oversee Manufacturing floor operations and provide quality oversight. Specific Job Responsibilities include but are not limited to:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
$74,960 - $103,070
Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe.
AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients' most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit Want to keep posted about our growth and learn more about our company? Follow us on LinkedIn and give us a quick Like on Facebook
AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.