GMP Operations Specialist
5 days ago
Job Summary:
We are seeking a highly motivated and detail-oriented GMP Cleaner to join our team at Spectraforce Technologies. As a GMP Cleaner, you will play a critical role in maintaining a clean and safe working environment in our manufacturing facilities.
Responsibilities:
- Support project teams as a CUCO (Clean Up Change Over) SME through start-up, commissioning, qualification, and licensure.
- Identify and address compliance, environmental, safety, and process deviations as appropriate while coordinating with relevant personnel.
- Actively support production areas by performing CUCO for Production Support & Media, Drug Substance, and Drug Product.
Key Activities:
- General Housekeeping/Facility & Equipment Cleaning
- Performing Bowie Dick Tests/Leak for Autoclaves
- Running Washers & Autoclaves
- Cleaning Closed Restricted Access Barriers (cRABS)
- Performing cRAB pre-checks (Seal Tests/Leak Tests/Glove Integrity Tests)
- Fill Line Support
- Material Management/Inventory Checks (Kitting and Staging Items)
- Gowning Restocking
- Filter Integrity Testing
- Waste Management
Requirements:
- High School Diploma/GED or higher
- Demonstrated written and verbal communications skills
- Must be able to successfully pass and maintain aseptic gowning qualifications
- Computer literacy (internet browsers, e-mail, spreadsheets, word processing)
- Must be willing and able to lift 50 lbs, bend, stoop, squat, crawl, twist, climb ladders, and wear a respirator
Preferred Qualifications:
- BioWork Certificate (working in an FDA or similar regulated industry)
- Experience with automated systems (MES, SAP)
- Experience with on-the-floor cGMP manufacturing and familiarity with regulatory requirements and Good Documentation Practices (GDP)
- Demonstrated ability to work both independently and as a part of a team
Working Conditions:
This role will initially be 1st Shift, Monday - Friday (7am - 3:30pm). Will transition to 3rd Shift, Sunday - Thursday (10pm - 6:30am) 3Q/4Q 2024.
What We Offer:
We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.
How to Apply:
Apply now to join our team and take the first step towards a rewarding career in manufacturing operations.
-
GMP Cleaning Specialist
4 days ago
Durham, North Carolina, United States Piper Companies Full timePiper Companies is seeking a dedicated and detail-oriented Cleanroom Maintenance Technician to join a tight knit team. The ideal candidate will be responsible for maintaining the cleanliness and compliance of our critical spaces in accordance with Standard Operating Procedures (SOPs). This role is crucial in ensuring the facility meets the highest standards...
-
GMP Manufacturing Technician
4 days ago
Durham, North Carolina, United States Duke University Full timeJob SummaryWe are seeking a highly skilled GMP Manufacturing Technician to join our team at the Duke University School of Medicine. The successful candidate will be responsible for the complex and specialized manufacturing of cellular products for clinical use.Key ResponsibilitiesPerform duties as dictated by standard operating procedures (SOPs) for the...
-
GMP Quality Assurance Specialist
4 weeks ago
Durham, North Carolina, United States Kelly Services, Inc. Full timeKelly Services, Inc.About the RoleAs a GMP Technician at Kelly Services, Inc., you will be responsible for ensuring the quality and compliance of products in a manufacturing environment.Key ResponsibilitiesConduct quality control tests on products to ensure they meet regulatory standards.Maintain accurate records of test results and communicate findings to...
-
GMP Quality Assurance Specialist
1 month ago
Durham, North Carolina, United States Kelly Services, Inc. Full timeAbout the RoleWe are seeking a highly skilled GMP Technician to join our team at Kelly Services, Inc.Key ResponsibilitiesConduct quality control tests on products to ensure compliance with industry regulations.Maintain accurate records of test results and communicate findings to management.Follow strict protocols and procedures to ensure compliance with...
-
Quality Assurance Operations Specialist
3 weeks ago
Durham, North Carolina, United States CARsgen Therapeutics Full timeJob Title: Quality Assurance Operations SpecialistAt CARsgen Therapeutics, we are seeking a highly skilled Quality Assurance Operations Specialist to join our team. This role will be responsible for providing day-to-day support of GMP operations at our RTP facility, ensuring the quality and integrity of our clinical and commercial products.Key...
-
GMP Quality Assurance Specialist
2 weeks ago
Durham, North Carolina, United States Kelly Services, Inc. Full timeKelly Services, Inc.Job SummaryAs a GMP Technician at Kelly Services, Inc., you will be responsible for ensuring the quality and integrity of products by conducting quality control tests, maintaining accurate records, and communicating findings to management. You will also be expected to follow strict protocols and procedures to ensure compliance with...
-
Maintenance Operations Specialist
4 weeks ago
Durham, North Carolina, United States The Spear Group Full timeJob Title: Maintenance & Repair Operations SpecialistJoin The Spear Group, a leading pharmaceutical manufacturing company, as a Maintenance & Repair Operations Specialist. In this role, you will be responsible for providing critical support to our pharma manufacturing site's preventive and corrective maintenance area.Key Responsibilities:Manage spare parts...
-
Durham, North Carolina, United States Beam Therapeutics Inc. Full timeJob Title: Associate Director, ManufacturingCompany Overview:Beam Therapeutics Inc. is a pioneering company in the field of precision genetic medicines. Our mission is to establish a leading platform for gene editing and delivery technologies, and we are committed to building internal manufacturing capabilities to support our growth.Position Overview:The...
-
Manufacturing Operations Specialist
4 days ago
Durham, North Carolina, United States KBI BioPharma Full timeJob SummaryThis position is responsible for supporting the execution of production activities in a GMP environment. The ideal candidate will maintain a sense of ownership of the production processes and manufacturing environment, ensuring all work is conducted following Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and Good...
-
Quality Assurance Specialist
1 month ago
Durham, North Carolina, United States Lilly Full timeJob Title: Quality Assurance SpecialistWe're seeking a highly skilled Quality Assurance Specialist to join our team at Lilly. As a key member of our Quality Assurance team, you will play a critical role in ensuring the quality and safety of our products.Job Summary:The Quality Assurance Specialist will be responsible for reviewing batch records, performing...
-
Manufacturing Operations Specialist
4 weeks ago
Durham, North Carolina, United States KBI BioPharma Full timeJob SummaryThis position is responsible for the execution of production activities in a GMP environment, focusing on media and buffer preparation. The ideal candidate will maintain a sense of ownership of the production processes and manufacturing environment, ensuring all work is conducted following Good Manufacturing Practices (GMP), Good Documentation...
-
Environmental Monitoring Specialist
3 weeks ago
Durham, North Carolina, United States Piper Companies Full timePiper Companies is currently seeking a skilled Environmental Monitoring Specialist to join their team in Durham, North Carolina. This role will play a crucial part in ensuring the quality and safety of pharmaceutical products by conducting laboratory sampling and testing in accordance with FDA/GMP regulations and company standards.Responsibilities for the...
-
Environmental Monitoring Specialist
3 weeks ago
Durham, North Carolina, United States Piper Companies Full timePiper Companies is currently seeking an Environmental Monitoring Specialist to join their team in Durham, North Carolina, as a key member of a multinational pharmaceutical manufacturer.Key ResponsibilitiesEnsure the quality and regulatory compliance of materials and products throughout the manufacturing process.Conduct environmental sampling, test utility...
-
Automation Systems Specialist
4 weeks ago
Durham, North Carolina, United States Technical Source Full timeJob Title: Automation SpecialistWe are seeking an experienced Automation Specialist to join our team at Technical Source in Durham, NC.Job SummaryThe Automation Specialist will be responsible for the operation and maintenance of water treatment equipment, ensuring reliability and efficiency in all processes.Key ResponsibilitiesInstrumentation Setup:...
-
Quality Assurance Specialist
4 weeks ago
Durham, North Carolina, United States Lilly Full timeAbout LillyLilly is a global healthcare leader that discovers, develops, and delivers medicines that help people live longer, healthier, and more active lives. We are committed to making a difference for people around the world by delivering innovative medicines and solutions that meet real needs.Job SummaryWe are seeking a Quality Assurance Specialist to...
-
Manufacturing Operations Specialist
5 days ago
Durham, North Carolina, United States KBI BioPharma Full timeJob SummaryThis position is responsible for the execution of production activities in a GMP environment, focusing on media and buffer preparation. The ideal candidate will maintain a sense of ownership of the production processes and manufacturing environment, ensuring all work is conducted following Good Manufacturing Practices (GMP), Good Documentation...
-
Instrumentation and Metrology Specialist III
3 weeks ago
Durham, North Carolina, United States HUMACYTE GLOBAL INC Full timeJob DescriptionThe Instrumentation and Metrology Specialist III will provide metrology, instrumentation, and controls knowledge and expertise for manufacturing, utility, and laboratory equipment throughout the Humacyte site. This role will partner with Quality, Engineering, and Operations groups to ensure strict compliance with GMP/GLP guidelines at all...
-
Environmental Monitoring Specialist
5 days ago
Durham, North Carolina, United States Zachary Piper Solutions, LLC Full timeEnvironmental Monitoring SpecialistZachary Piper Solutions, LLC is seeking a highly skilled Environmental Monitoring Specialist to join our team in Durham, North Carolina. As a key member of our quality assurance team, you will be responsible for ensuring the highest standards of quality and regulatory compliance in our manufacturing...
-
Automation Systems Specialist
4 weeks ago
Durham, North Carolina, United States Technical Source Full timeAutomation Specialist Job DescriptionTechnical Source is seeking an experienced Automation Specialist to support the operation and maintenance of water treatment equipment, ensuring reliability and efficiency in all processes.Key Responsibilities:Instrumentation Setup: Configure and integrate instrumentation with control panels to ensure seamless...
-
Environmental Monitoring Specialist
4 days ago
Durham, North Carolina, United States Piper Companies Full timePiper Companies is seeking a highly skilled Environmental Monitoring Specialist to join their team in Durham, North Carolina. The ideal candidate will work closely with the manufacturing and environmental monitoring testing groups to ensure all materials entering the product are processed, tested, packaged, stored, and distributed in compliance with...