QA Associate I, Hardware/Systems
2 weeks ago
Repligen is an innovative life sciences company focused on developing and commercializing high-value bioprocessing products, technologies, and solutions critical in the production of biologic drugs.
We are currently seeking a QA Associate I to join our Quality team in Marlborough.
The successful candidate will be responsible for assisting the QA department to revise/create, file, organize, and review production documents. The candidate will work closely with the manufacturing team and document control department to ensure the changes are accurate and are made effective in a timely manner. This position involves completing the QA review of production records, including verification of raw materials used, verification of calculations, critical process steps, and evaluation of Factory Acceptance testing (FAT).
The QA Associate I will actively participate in the Repligen ISO 9001 Quality Management System and will be responsible for the review of system batch records and binder builds for Xcell ATF and Systems product lines and other TFF and TFDF systems.
Responsibilities
Responsibilities:
- Must be familiar with Factory Acceptance Test (FAT) for stainless steel cell culture systems
- Must have knowledge of ASME BPE codes and requirements
- Must be able to perform Quality Assurance on manufacturing of system product lines
- Must be able to build binders (Hardcopy/ eCopy) for Factory Acceptance Test (FAT)
- Must be familiar with GMP/ non-GMP systems used by pharmaceuticals
- Must be able to work with Document Control for issuance of batch records
- Must have good communication skills to work with customers
Requirements:
- At a minimum, a BA/BS degree (in a Biological Science, Engineering, or Physical Science preferred).
- Minimum 0-2 years' experience in Quality Assurance in an ISO 9001 certified Quality Management System or equivalent
- Ability to identify and ensure active and thorough investigations of quality issues identifying root causes and implementing corrective actions. Identifies and controls manufacturing process defects (scrap, nonconforming material, customer complaints) is highly preferred.
Excellent Benefits
- Health Insurance available on day one
- 4 Competitive Medical Plan Options
- Dental, Vision, Life and Disability Insurance Plans
- 401K
- Health Care Savings Account
- Well Being Programs
- 20 Days of PTO
- Tuition Reimbursement Program
-
QA Associate I, Hardware/Systems
5 days ago
Marlborough, United States Repligen Full timeOverview Repligen is an innovative life sciences company focused on developing and commercializing high-value bioprocessing products, technologies, and solutions critical in the production of biologic drugs. We are currently seeking a QA Associate I to join our Quality team in Marlborough. The successful candidate will be responsible for assisting the QA...
-
QA Associate I, Hardware/Systems
2 weeks ago
Marlborough, United States Repligen Full timeOverview For a complete understanding of this opportunity, and what will be required to be a successful applicant, read on. Repligen is an innovative life sciences company focused on developing and commercializing high-value bioprocessing products, technologies, and solutions critical in the production of biologic drugs. We are currently seeking a QA...
-
QA Associate I, Hardware/Systems
4 weeks ago
Marlborough, United States Repligen Full timeOverviewRepligen is an innovative life sciences company focused on developing and commercializing high-value bioprocessing products, technologies, and solutions critical in the production of biologic drugs.We are currently seeking a QA Associate I to join our Quality team in Marlborough. The successful candidate will be responsible for assisting the QA...
-
Hardware Analyst
2 days ago
Marlborough, United States Robert Half Full timeJob DescriptionJob DescriptionCurrently sourcing for a contract employment opportunity for a Senior Analog Hardware Engineer to work onsite in Massachusetts. This role will primarily involve participating in the design and development of products for the power generation, transmission, and distribution industry. Responsibilities:• Participating in the...
-
Principal Hardware Engineer
2 days ago
Marlborough, United States Robert Half Full timeJob DescriptionJob DescriptionWe are offering an exciting opportunity for a Principal Hardware Engineer in Marlboro, Massachusetts. In this role, you will be involved in the design and development of analog circuits, PCB layouts, and power systems in the tech industry. This position is based in a dynamic and collaborative workplace.Responsibilities:• Lead...
-
Manufacturing Associate I
4 weeks ago
Marlborough, United States Repligen Full timeOverviewReporting to the Manufacturing Supervisor, the Manufacturing Associate will perform various activities in the production of tangential flow filtration cassettes. The ability to successfully cross-train into other areas/functions may be required based on the changing needs of the department. The successful candidate will play a key role in ensuring...
-
Manufacturing Associate I
2 days ago
Marlborough, United States Repligen Full timeOverviewReporting to the Manufacturing Supervisor, the Manufacturing Associate will perform various activities in the production of tangential flow filtration cassettes. The ability to successfully cross-train into other areas/functions may be required based on the changing needs of the department. The successful candidate will play a key role in ensuring...
-
Supplier QA Associate Director
2 days ago
Marlborough, MA, United States Boston Scientific Full timeRecruiter: Spencer Gregory Hale Supplier QA Associate Director About the role: The Endoscopy and Urology Associate Director of Supplier Quality Engineering External Operations (Sourced Finished Medical Devices) leads a team of Supplier Quality Engineering Managers to assure supplier and product quality for external manufactured devices. This position...
-
Senior Linux System Administrator
5 days ago
Marlborough, United States Raytheon Full timeDate Posted: 2024-11-23 Country: United States of America Location: MA801: Marlborough, MA 1001 Boston Post Road Building 2, Marlborough, MA, 01752 USA Position Role Type: Onsite At Raytheon, the foundation of everything we do is rooted in our values and a higher calling – to help our nation and allies defend freedoms and deter aggression. We bring the...
-
QA Compliance Lead
5 days ago
Marlborough, United States Integrated Resources Full timeIRI believes in commitment, integrity, and strategic workforce solutions. Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled, and retained key...
-
QA Compliance Lead
1 week ago
Marlborough, United States Integrated Resources Full timeIRI believes in commitment, integrity, and strategic workforce solutions. Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled, and retained key...
-
QA Compliance Lead
1 week ago
Marlborough, United States Integrated Resources Full timeIRI believes in commitment, integrity, and strategic workforce solutions. Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled, and retained key...
-
Supplier QA Associate Director
3 days ago
Marlborough, MA, United States Boston Scientific Gruppe Full timeThe Endoscopy and Urology Associate Director of Supplier Quality Engineering External Operations (Sourced Finished Medical Devices) leads a team of Supplier Quality Engineering Managers to assure supplier and product quality for external manufactured devices. This position offers the successful candidate the opportunity to be an enabler for revenue growth...
-
QA Test Designer
6 days ago
Marlborough, United States Talent Groups Full timePosition Summary:Designs testing as part of various projects for the IS Project Management Office in collaboration with UMMH clinical, operational, vendor, and IS stakeholders.Develops quality assurance tools, activities, and reporting that support the quality goals of IS teams, outside of projects, and collaborates with those groups to incorporate those...
-
IT Software Systems Engineer
3 weeks ago
Marlborough, United States BJ's Wholesale Club Full timeJoin our team of more than 34,000 team members, supporting our members and communities in our Club Support Center, 235+ clubs and eight distribution centers. BJ’s Wholesale Club offers a collaborative and inclusive environment where all team members can learn, grow and be their authentic selves. Together, we’re committed to providing outstanding service...
-
Engineer - Validation
3 weeks ago
marlborough, United States Katalyst Healthcares & Life Sciences Full timeResponsibilities: The Validation Engineer (Mid-Level) will be responsible for leading the verification. validation efforts on various industrial automation projects (Plant Pax) will create reports, and ensure that all requirements have been verified. - Approve test cases and protocols using Azure DevOps. - Create verification and validation reports,...
-
Engineer - Validation
1 day ago
Marlborough, United States Katalyst Healthcares & Life Sciences Full timeResponsibilities: The Validation Engineer (Mid-Level) will be responsible for leading the verification. validation efforts on various industrial automation projects (Plant Pax) will create reports, and ensure that all requirements have been verified. - Approve test cases and protocols using Azure DevOps. - Create verification and validation reports,...
-
Manufacturing Associate I
2 days ago
Marlborough, United States Repligen Full timeOverview This position is for a Manufacturing Associate in Repligens Systems manufacturing group working on a wide variety of electro-mechanical assemblies. The operator will be responsible for all aspects of manufacture, including electronic/mechanical assembly and testing. This person will also be responsible for documenting all work in production batch...
-
Senior Information System Security
2 months ago
Marlborough, United States Raytheon Technologies Full timeDate Posted: 2024-10-23 Country: United States of America Location: MA801: Marlborough, MA 1001 Boston Post Road Building 2, Marlborough, MA, 01752 USA Position Role Type: Onsite At Raytheon, the foundation of everything we do is rooted in our values and a higher calling – to help our nation and allies defend freedoms and deter aggression. We...
-
Protection and Control Systems Specialist
1 week ago
Marlborough, Massachusetts, United States Doble Engineering Company Full timeJob OverviewDoble Engineering Company is seeking a highly skilled Protection and Control Systems Specialist to join our team. As a key member of our organization, you will play a vital role in providing technical support and training to customers on the operation and application of our protection hardware and software solutions.