![Lantheus](https://media.trabajo.org/img/noimg.jpg)
QMS Systems Lead
3 weeks ago
Lantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and have helped physicians enhance patient care with our broad product portfolio.
Lantheus is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease. Lantheus is in search of an innovative, transformative, high-energy, experienced Business Analyst for our Quality Systems team.
At Lantheus. our purpose and values guide our behaviors in all interactions and play a vital role in creating a dynamic environment that contributes to our success. Every employee is crucial to our success, we respect one another and act as one knowing that someone’s health is in our hands. We believe in helping people be their best and are seeking to bring together a diverse group of individuals with different viewpoints and skills sets to be a part of a productive and inclusive team.
This individual will support the Quality business community executing requirements and coordinating with the technical community, IT project teams and business clients for Quality technical solutions including QMS, CDS, QC RDS, LIMS, NuGenesis ALM, etc. This role will work with the business to define functional business requirements and help develop, execute, deploy, and support the current Quality technical solutions and play a key role implementing new solutions supporting the Lantheus Digital Strategy.
Key Responsibilities/Essential Functions
Gather, develop, clarify and document functional/user business requirements
Transform the users’ requirements into functional requirements
Strong understanding of LIMS solutions (LabVantage preferred)
Knowledge of integrating LIMS with Empower CDS
Experience with the administration of at least one QMS Solution (AsurX, TrackWise, Veeva, MasterControl, etc.)
Experience with the administration at least one CDS systems (Empower preferred)
Experience with IT setup, troubleshooting, back-up, upgrades, & decommissioning lab equipment/software such as HPLC, GC, AA, UV/FTIR/Raman, titrators, endotoxins, total particulates, balances, pH meters, etc.
Ability to collaborate with Project Managers on issues, concerns, schedules of deliveries and completion estimates
Experience working in GxP validated environment and have contributed to the creation and execution of validation documents such as IQ and OQ
Skills And Experience And Education
BA/BS degree in Information Technology or Computer Science with 5+ years progressive experience in data integration
Experience in the following areas preferred: Quality Controls within Manufacturing, Quality Systems & Document Management, Quality Assurance, Computer Systems Validation, GxP, Validated Change Control and Product Life Cycle Management
Understanding of Computer Systems Validation and the full Software Life Cycle management
Strong written and verbal communication skills
Strong collaboration skills with the ability to work in a team dynamic across multiple functional organizations
Experience in the life science industry or like industry essential
Demonstrated analytical, troubleshooting, and problem-solving skills
Other Requirements
Non-routine overnight travel based on business need.
#J-18808-Ljbffr
-
QA Head, Medical Device
3 days ago
Billerica, United States Unicon Pharma Inc Full timeResponsible for all aspects of QA for Medical Device and combination products manufactured either on site or at third party contract manufacturer. Ensure all medical devices manufactured meet established specifications.Ensure compliance of establish Quality Management System (QMS) and in compliance with corporate requirements and all applicable FDA Part 4,...
-
Quality Manager
1 week ago
Billerica, United States Amtech Full time**Organization Summary** Founded in 1981, Amtech Systems is a trusted global supplier of essential semiconductor equipment and consumables serving various industries within the power semiconductor market, including mobile, computing, industrial, automotive, telecom, medical, and more. Our diversified product portfolio enables us to manufacture and sell our...
-
Senior Associate, IT Systems Administrator
4 weeks ago
Billerica, United States Kaztronix Full timeSenior Associate, IT Systems Administrator Billerica, MA Jo b Summary Manage day-to-day System Administration, user support and implementation of GxP Computerized Systems in QC Analytical Lab Manufacturing and other regulatory operations including, but not limited to, networked and non- networked standalone instruments, firmware based instruments, HMI's,...
-
Senior Manager, Medical Device QA
4 weeks ago
Billerica, United States SGA Full timeSoftware Guidance & Assistance, Inc., (SGA), is searching for an Senior Manager, Medical Device QA for FULL TIME assignment with one of our premier Pharmaceutical Services clients in Billerica, MA . Responsibilities : Responsible for all aspects of QA for Medical Device and combination products manufactured either on site or at third party contract...
-
Senior Compliance Specialist
1 month ago
Billerica, United States Kaztronix Full timeSr. Associate Compliance (Product Quality) Fulltime Onsite We can Relocate Job Duties: The Sr. Associate Compliance provides scientific support in the root cause analysis and closure of OOS investigations, OOT investigations and product quality complaints; ensures compliance with Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP)...
-
Senior Compliance Specialist
7 days ago
Billerica, United States Kaztronix Full timeSr. Associate Compliance (Product Quality) Fulltime Onsite We can Relocate Job Duties: The Sr. Associate Compliance provides scientific support in the root cause analysis and closure of OOS investigations, OOT investigations and product quality complaints; ensures compliance with Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP)...
-
Senior Compliance Specialist
2 months ago
Billerica, United States Kaztronix Full timeSr. Associate Compliance (Product Quality) Fulltime Onsite We can Relocate Maximise your chances of a successful application to this job by ensuring your CV and skills are a good match. Job Duties: The Sr. Associate Compliance provides scientific support in the root cause analysis and closure of OOS investigations, OOT investigations and product quality...
-
Senior Compliance Specialist
2 months ago
Billerica, United States Kaztronix LLC Full timeSr. Associate Compliance (Product Quality) Fulltime Onsite We can RelocateJob Duties: The Sr. Associate Compliance provides scientific support in the root cause analysis and closure of OOS investigations, OOT investigations and product quality complaints; ensures compliance with Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP) and...
-
Senior Compliance Specialist
2 months ago
Billerica, United States Kaztronix Full timeSr. Associate Compliance (Product Quality) Fulltime Onsite We can Relocate Job Duties: The Sr. Associate Compliance provides scientific support in the root cause analysis and closure of OOS investigations, OOT investigations and product quality complaints; ensures compliance with Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP)...
-
Senior Compliance Specialist
3 weeks ago
Billerica, United States Kaztronix Full timeSr. Associate Compliance (Product Quality) Fulltime Onsite We can Relocate Job Duties: The Sr. Associate Compliance provides scientific support in the root cause analysis and closure of OOS investigations, OOT investigations and product quality complaints; ensures compliance with Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP)...
-
Senior Compliance Specialist
3 weeks ago
Billerica, United States Kaztronix LLC Full timeSr. Associate Compliance (Product Quality) Fulltime Onsite We can RelocateJob Duties: The Sr. Associate Compliance provides scientific support in the root cause analysis and closure of OOS investigations, OOT investigations and product quality complaints; ensures compliance with Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP) and...
-
Senior Compliance Specialist
2 months ago
Billerica, United States Kaztronix LLC Full timeSr. Associate Compliance (Product Quality) Fulltime Onsite We can RelocateJob Duties: The Sr. Associate Compliance provides scientific support in the root cause analysis and closure of OOS investigations, OOT investigations and product quality complaints; ensures compliance with Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP) and...
-
Senior Compliance Specialist
2 months ago
Billerica, United States Kaztronix LLC Full timeSr. Associate Compliance (Product Quality) Fulltime Onsite We can RelocateJob Duties: The Sr. Associate Compliance provides scientific support in the root cause analysis and closure of OOS investigations, OOT investigations and product quality complaints; ensures compliance with Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP) and...
-
Senior Compliance Specialist
3 weeks ago
Billerica, United States Kaztronix LLC Full timeSr. Associate Compliance (Product Quality) Fulltime Onsite We can RelocateJob Duties: The Sr. Associate Compliance provides scientific support in the root cause analysis and closure of OOS investigations, OOT investigations and product quality complaints; ensures compliance with Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP) and...
-
Senior Manager, Quality Assurance
3 weeks ago
Billerica, United States Sun Pharmaceutical Industries, Inc. Full timePress Tab to Move to Skip to Content Link Select how often (in days) to receive an alert: Create Alert Title: Senior Manager, Quality Assurance - Medical Device Date: May 18, 2024 Company: Sun Pharmaceutical Industries, Inc (USA) Job Summary Responsible for all aspects of QA for Medical Device and combination products manufactured either on site or at third...
-
Senior Manager, Quality Assurance
3 days ago
Billerica, Massachusetts, United States Sun Pharmaceutical Industries Full timeJob Summary Responsible for all aspects of QA for Medical Device and combination products manufactured either on site or at third party contract manufacturer. Ensure all medical devices manufactured meet established specifications. Ensure compliance of establish Quality Management System (QMS) and in compliance with corporate requirements and all applicable...
-
Senior Manager, Quality Assurance
3 weeks ago
Billerica, United States Sun Pharmaceutical Industries, Inc. Full timePress Tab to Move to Skip to Content Link Select how often (in days) to receive an alert: Create Alert Title: Senior Manager, Quality Assurance - Medical Device Date: May 18, 2024 Company: Sun Pharmaceutical Industries, Inc (USA) Job Summary Responsible for all aspects of QA for Medical Device and combination products manufactured either on site or at third...
-
Sr. Associate Compliance
4 weeks ago
Billerica, United States Sun Pharmaceutical Industries Full timeCOME WORK FOR US - INVESTING IN YOU AS A SUN PHARMA EMPLOYEE! * Medical, Dental, Vision Benefits * Health Savings Account (HSA), Flexible Spending Account (FSA) * Prescription Drug Coverage * Telehealth and Behavior Health Services * Income Protection - Short Term and Long Term Disability Benefits * Retirement Benefits - 401k Company Match on Day One (100%...
-
Sr. Associate Compliance
1 week ago
Billerica, United States Sun Pharmaceutical Industries Full timeCOME WORK FOR US - INVESTING IN YOU AS A SUN PHARMA EMPLOYEE! * Medical, Dental, Vision Benefits * Health Savings Account (HSA), Flexible Spending Account (FSA) * Prescription Drug Coverage * Telehealth and Behavior Health Services * Income Protection - Short Term and Long Term Disability Benefits * Retirement Benefits - 401k Company Match on Day One (100%...
-
Senior Manager, Quality Assurance
4 weeks ago
Billerica, United States Sun Pharma Full timeJob Summary for all aspects of QA for Medical Device and combination products manufactured either on site or at third party contract manufacturer. Ensure all medical devices manufactured meet established specifications. compliance of establish Quality Management System (QMS) and in compliance with corporate requirements and all applicable FDA Part 4, Part...