Current jobs related to Quality Systems Specialist, Complaints - North Billerica - Randstad Life Sciences
-
Quality Complaint Investigator
2 months ago
Billerica, United States EPM Scientific Full time**Quality Assurance Specialist - Medical Device Sector**!!MUST BE ABLE TO WORK UNDER W2!!Are you a dedicated Quality Assurance Professional looking to take on a challenging new role in the medical device sector? We are seeking an experienced and meticulous individual to embark on a 6-month contract, with potential for extension, as part of our client's...
-
Quality Complaint Investigator
1 month ago
Billerica, United States EPM Scientific Full time**Quality Assurance Specialist - Medical Device Sector**!!MUST BE ABLE TO WORK UNDER W2!!Are you a dedicated Quality Assurance Professional looking to take on a challenging new role in the medical device sector? We are seeking an experienced and meticulous individual to embark on a 6-month contract, with potential for extension, as part of our client's...
-
Quality Assurance Compliance Specialist
1 month ago
Billerica, United States Phaidon International Full timeEPM are looking for two Quality Assurance Specialists with extensive experience in compliance responsibilities. The specialist in question will be expected to be On-Site 5 days a week, this would be a non-negotiable! The work would involve experience working with systems such as Trackwise, Veeva or QMS.Duties and Responsibilities:Investigates complaints to...
-
Quality Assurance Compliance Specialist
1 month ago
Billerica, United States Phaidon International Full timeEPM are looking for two Quality Assurance Specialists with extensive experience in compliance responsibilities. The specialist in question will be expected to be On-Site 5 days a week, this would be a non-negotiable! The work would involve experience working with systems such as Trackwise, Veeva or QMS.Duties and Responsibilities:Investigates complaints to...
-
Head of Quality Systems
1 week ago
North Billerica, United States Lantheus Medical Imaging Inc Full timePosition OverviewLantheus Medical Imaging Inc. is a leading organization in the field of medical imaging, dedicated to enhancing patient care through innovative diagnostics and therapeutics. With a rich history spanning over 60 years, we pride ourselves on our entrepreneurial spirit and commitment to excellence.Role SummaryThe individual in this pivotal role...
-
Head of Quality Systems and Compliance
1 week ago
North Billerica, United States Lantheus Medical Imaging Inc Full timePosition OverviewLantheus Medical Imaging Inc., a leader in the medical imaging sector, is seeking a dynamic individual to spearhead our Quality Systems & Compliance team. With a legacy of over 60 years, Lantheus is dedicated to enhancing patient care through innovative diagnostics and therapeutic solutions.Role SummaryThe selected candidate will be pivotal...
-
Director, Quality Systems
3 months ago
North Billerica, United States Lantheus Medical Imaging Inc Full timeJob DescriptionJob DescriptionLantheus 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 has helped physicians enhance patient care with its broad product portfolio. Lantheus is an entrepreneurial, agile, growing...
-
Pharmaceutical Quality Complaint Specialist
3 days ago
North Chicago, Illinois, United States AbbVie Full timeJob OverviewObjectiveThe individual will be part of AbbVie's global quality team, focusing on the processing of complaints and inquiries related to pharmaceutical products, medical devices, and combination products. Engagement with both internal and external stakeholders, including healthcare professionals, purchasing agents, and regulatory bodies, is...
-
Head of Quality Systems and Compliance
3 days ago
North Billerica, United States Lantheus Medical Imaging Inc Full timeJob OverviewLantheus Medical Imaging Inc. is a leader in the medical imaging sector, with a rich history of over 60 years in enhancing patient care through innovative diagnostic solutions. Our organization is dynamic and rapidly evolving, dedicated to providing cutting-edge diagnostics, targeted therapies, and AI-driven solutions that empower healthcare...
-
Quality Assurance Compliance Analyst
4 days ago
Billerica, Massachusetts, United States Phaidon International Full timePhaidon International is seeking two dedicated Quality Assurance Specialists with a strong background in compliance duties. The selected candidates will be required to work On-Site five days a week, which is a firm requirement. The role necessitates familiarity with systems such as Trackwise, Veeva, or Quality Management Systems (QMS).Key...
-
Quality Management Systems Specialist
1 week ago
Billerica, Massachusetts, United States Lantheus Full timeCompany OverviewLantheus is a leading organization in the medical imaging sector, dedicated to enhancing patient care through innovative diagnostics and therapeutics. With a presence in multiple countries, we pride ourselves on our entrepreneurial spirit and commitment to quality.Position SummaryWe are seeking a dynamic and experienced Business Analyst to...
-
Lead Quality Assurance Compliance Specialist
1 week ago
Billerica, Massachusetts, United States Wimmer Solutions Full timeSENIOR ASSOCIATE, QA COMPLIANCE - APQR (ANNUAL PRODUCT QUALITY REVIEW)Location: Billerica, MA (Onsite)Position ID: 22911At Wimmer Solutions, we prioritize community and collaboration. Our commitment to excellence has established us as a leader in delivering innovative business and technology solutions that empower organizations to achieve their strategic...
-
Product Complaint Associate
3 months ago
North Wales, United States Collabera Full timeJob DescriptionJob DescriptionAbout the Role:Be able to open the sample to do a visual inspection and triage and classify them accordingly.Be able to process and inspect various Organon Products like inhalers, syringes, vials, etc.Have good communication skills to hold productive conversations with multiple cross-functional teams.Have leadership skills and...
-
Optical Systems Testing Specialist
3 days ago
Billerica, Massachusetts, United States FLIR Commercial Systems Inc (US) Full timeThis position focuses on the evaluation of opto-mechanical systems in accordance with production specifications, utilizing a variety of hand tools, measurement instruments, and testing apparatus.Company Overview:FLIR Commercial Systems Inc is a prominent provider of advanced sensing technologies, dedicated to upholding the highest ethical standards in its...
-
Quality Assurance Specialist
1 week ago
Billerica, Massachusetts, United States Lantheus Full timeLantheus, a leader in the medical imaging sector, is dedicated to enhancing patient care through innovative diagnostics and therapeutic solutions. With a commitment to quality and compliance, we are seeking a Quality Assurance Specialist to join our dynamic team. This role involves providing comprehensive Quality oversight for the aseptic fill/finish...
-
Quality Assurance Specialist
1 week ago
North Billerica, United States Antenna Research Associates Inc Full timeJob OverviewCompany OverviewAntenna Research Associates, Inc. is a prominent C5ISR organization that innovates, fabricates, evaluates, and deploys advanced technologies aimed at enhancing national security through superior situational awareness, threat detection, and communication systems.Our cutting-edge, integrated solutions, assemblies, and subsystems are...
-
Quality Assurance Specialist
3 days ago
North Billerica, United States SI2 Technologies Inc Full timeCompany OverviewSI2 Technologies Inc. is a prominent firm specializing in C5ISR solutions, dedicated to designing, producing, testing, and implementing advanced technologies that offer unmatched situational awareness, threat detection, and communication capabilities for the national security sector. Our innovative, integrated solutions, assemblies, and...
-
Quality Assurance Specialist
3 days ago
North Billerica, United States SI2 Technologies Inc Full timeCompany OverviewSI2 Technologies Inc. is a prominent C5ISR organization that innovates, fabricates, tests, and deploys advanced technologies, delivering exceptional situational awareness, threat detection, and communication solutions to the national security sector. Our groundbreaking, integrated solutions, assemblies, and subsystems are designed to meet the...
-
Quality Assurance Specialist
1 week ago
North Billerica, United States SI2 Technologies Inc Full timeCompany OverviewSI2 Technologies Inc. is a prominent player in the C5ISR sector, dedicated to designing, producing, testing, and implementing cutting-edge technologies that enhance national security through superior situational awareness, threat detection, and communication capabilities. Our innovative, integrated solutions, assemblies, and subsystems are...
-
Quality Assurance Specialist
1 week ago
North Billerica, United States Antenna Research Associates Inc Full timeJob OverviewCompany OverviewAntenna Research Associates, Inc. is a prominent C5ISR organization dedicated to the design, production, testing, and installation of cutting-edge technologies that enhance national security through superior situational awareness, threat detection, and communication capabilities.Our innovative, integrated solutions, assemblies,...
![Randstad Life Sciences](https://media.trabajo.org/img/noimg.jpg)
Quality Systems Specialist, Complaints
2 months ago
Immediate opportunity for Quality Systems Specialist, Compliants with a leading pharmaceutical/diagnostics company located in North Billerica, MA. As a Quality Systems Complaints Specialist, you will be responsible for investigating Product Quality Complaints. Other responsibilities may include authoring and revising Quality System Documentation, trending and evaluating Product Quality, and coordinating the Annual Product Quality Reports (APQR), and Metrics Reporting.
Schedule Shift: 1st shift, Mon.-Fri.; Onsite 4-5 days in Billerica until trained, then 3 days onsite. Can do a short week for summer hours.
Position Type: Contract role for 6 mos. (through Jan 2025); extension possible
Pay Rate: $50+/hr.
Essential Duties and Responsibilities:
- Initiates product quality complaints in our Quality Management System (QMS).
- Performs product quality complaint investigations and assigns investigation tasks to technical functions as needed.
- Collaborates with Technical Support, Engineering, Analytical Laboratories, Manufacturing, Validation, Customer Service and Regulatory Affairs groups to ensure timely complaint investigations and closure.
- Evaluates scientific data for trends, drives investigations, and proposes the need for changes to manufacturing or control procedures.
- Documents complaint investigation activities and summary. Responsible for timely closure of complaints.
- Recommends the need for further investigation and escalation to CAPA. Drives closure of associated investigation(s) and CAPA(s).
- Performs routine trending of product complaints and evaluating trends, escalating issues as necessary.
- Responsible for Annual Product Quality Reports (APQR). Collaborates with internal stakeholders on data collection and ensures timely completion of reports.
- Responsible for collecting and reporting metrics as required per internal procedures and as requested by leadership.
- Actively promotes safety rules and awareness. Demonstrates good safety practices at all times including the appropriate use of protective equipment. Reports and takes initiative to correct safety and environmental hazards.
- Actively demonstrates company values.
- Other duties as assigned.
Qualifications:
- Bachelor of Science in a technical discipline or equivalent combination of education and experience.
- Five (5) or more years' experience in quality and manufacturing in the pharmaceutical, medical device, or biological industries.
- Experienced in investigating and documenting Customer Product Quality Complaints, effectively communicating in written form, and collaborating with various internal and external business partners in problem resolution.
- Experienced with metrics reporting.
- Organized, detail oriented and self-motivated.
- Exposure to Annual Product Quality Reviews preferred, but not required.