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Site Compliance Quality Head

Software Guidance & Assistance

•

Billerica, Massachusetts, USA

Full-time

Software Guidance & Assistance, Inc., (SGA), is searching for a Site Compliance Quality Head for a FULL-TIME assignment with one of our premier Pharmaceutical Services clients in Billerica, MA. Responsibilities: Implement and manage the records in electronic Quality Systems, such as QMS, EDMS, and LMS, etc. providing procedures and training for employees to effectively use the electronic Quality Systems Supervise the QA Documentation department in the creation, issuance, maintenance, archivi
Posted 22 days ago | Updated 6 hours ago

Sr. SAS Programmer

Katalyst Healthcares and Lifesciences

•

Charlotte, North Carolina, USA

Full-time

Responsibilities: Lead the development and implementation of submission-ready SDTM datasets in accordance with regulatory requirements (e.g., FDA, EMA, PMDA). Collaborate with regulatory affairs and quality assurance teams to ensure compliance with submission guidelines and standards. Perform thorough quality control checks to validate the accuracy and completeness of submission datasets. Coordinate the preparation and documentation of submission packages, including data specifications and v
Posted 52 days ago | Updated 9 hours ago

Oracle OPM Consultant

Arcturus Consulting Services Inc.

•

Albany, New York, USA

Contract, Third Party

Role: Oracle OPM Consultant Location: Albany, New York (onsite) Experience Level: 10+ years Project Type: Application Managed Services (AMS) Job Summary: The Oracle OPM Consultant will be responsible for the managing the support project including but not limited to implementation, configuration, and ongoing support of Oracle Process Manufacturing (OPM) modules within the pharmaceutical manufacturing environment. The role requires expertise in Oracle OPM and its integration with other Oracle modu
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Posted 29 days ago

Sr. Principal Software Quality Engineer

Katalyst Healthcares and Lifesciences

•

Bellevue, Washington, USA

Full-time

Responsibilities: Partner with development teams to ensure compliance with FDA, ISO 13485, IEC 62304, ISO 14971, and cybersecurity standards. Provide quality oversight for Design History Files (DHF), risk management, V&V, and design controls. Lead software risk management (RMF), including risk evaluation, control, and mitigation. Drive Secure Product Development Framework (SPDF) and software security best practices. Support Agile software development teams, ensuring regulatory and quality compli
Posted 60+ days ago | Updated 9 hours ago

SAS Programmer

Katalyst Healthcares and Lifesciences

•

San Diego, California, USA

Full-time

Responsibilities: Serves as lead programmer for assigned projects to provide statistical and programming support in one or more Phase I- clinical studies. Design and perform quality checks on analysis datasets, tables, listings, figures (TFL), and written reports to support clinical trial results using SAS. Create and review annotated CRF to STDM datasets. Produce and maintain technical programming specification documents. Lead and actively participate in client and project review meetings.
Posted 60+ days ago | Updated 9 hours ago

Commissioning & Qualification (C&Q) Engineer

Katalyst Healthcares and Lifesciences

•

Harrisburg, Pennsylvania, USA

Full-time

Responsibilities: Develop and execute commissioning protocols (FAT, SAT, IQ, OQ and PQ) for equipment, systems, and facilities. Perform system startup, debugging, and initial testing of process and utility systems. Ensure that systems are installed and operating according to design specifications. Collaborate with engineering, manufacturing, and quality teams during equipment installation and commissioning. Review and verify system documentation, such as P&IDs, wiring diagrams, and datashee
Posted 60+ days ago | Updated 9 hours ago

Engineer II, Quality Compliance

Masimo Corporation

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Irvine, California, USA

Full-time

Job Description Job Summary The Senior Engineer, Quality Compliance will be responsible for the specific area of Analysis of Data in the Quality Compliance department. This position will interface with representatives from different departments within the organization (e.g. Quality Compliance, Quality Assurance, Engineering, and Operations) to prepare metrics for routine quality reviews and management reviews. This individual will also be responsible for assisting in the development of new pro
Posted 55 days ago | Updated 9 hours ago

Associate Engineer

Aditi Consulting

•

New Albany, Ohio, USA

Contract

Payrate: $25.00 - $30.00/hr. Summary: In this role you will provide technical engineering support on all system/equipment optimization strategies, upgrades, replacements, repairs, and modifications. You will evaluate and determine if process equipment maintenance, and technical cleaning systems are maintained in compliance with all applicable industry standards, regulatory standards and FDA standards in the Inspection and Packaging area. Responsibilities: Take part in the coordination of tech su
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Posted 3 days ago | Updated 3 hours ago

Lead Engineer - MES Opcenter

Katalyst Healthcares and Lifesciences

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Remote or New York, USA

Full-time

Job Description: The Lead Engineer will lead a team of technical resources to design, develop, configure, and test MES (Manufacturing Execution Systems) solutions. They will be directly responsible for leading resources contracted vi third-party and through other Pharmaceutical organizations to develop & deploy MES application software to Medical Device manufacturing sites globally. Responsibilities: Act as subject matter expert on system design and architecture. Solutioning and designing new
Posted 30 days ago | Updated 9 hours ago

Data Manager MedRA Coder (WHODrug)

General Dynamics

•

Frederick, Maryland, USA

Full-time

Type of Requisition: Pipeline Clearance Level Must Currently Possess: None Clearance Level Must Be Able to Obtain: None Public Trust/Other Required: NACI (T1) Job Family: Medical Affairs Job Qualifications: Skills: Clinical Data Management, Electronic Data Capture (EDC), MedDRA Coding, WHODrug Certifications: None Experience: 5 + years of related experience ship Required: Yes Job Description: GDIT's Military Health team is hiring Data Manager MedRA Coder (WHODrug) to support the Office of
Posted 20 days ago | Updated 9 hours ago

Engineer III, Validation

Thermo Fisher Scientific

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Remote or Waltham, Massachusetts, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description COMPANY: Thermo Fisher Scientific Inc. LOCATION: 168 Third Avenue, Waltham, MA 02451 TITLE: Engineer , Validation HOURS: Monday to Friday, 8:00 am to 5:00 pm DUTIES: Perform technical diagnosis of operational problems, repairs, and calibrations on a wide range of laboratory equipment to ensure that the equipment is operating to the customer's complete satisfaction and manufacture specifications; Perform techn
Posted 31 days ago | Updated 9 hours ago

Engineering Manager

Flextronics

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Austin, Texas, USA

Full-time

Job Posting Start Date 06-10-2025 Job Posting End Date 08-30-2025 Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world. A career at Flex offers the opportunity to make a difference and invest in your growth in a respectful, inclusive, and collaborative environment. If you are excited about a role but don't meet every bullet point, we encourage you to apply and join us to create the extraord
Posted 41 days ago | Updated 9 hours ago

Production Tech 1-3rd Shift

bioMerieux

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Hazelwood, Missouri, USA

Full-time

Job Description Low-cost medical, dental, and vision benefits starting day one 11 paid holidays 160 hours of paid time off Annual bonus 9.5% 401k company contribution with no vesting period Tuition reimbursement up to $10000 per calendar year Onsite cafeteria with daily food stipend Pay is $17.50-$19.50/hr based upon experience Position Summary: The Production Technician I position is responsible for the operation of high speed equipment used in the production and packaging of VITEK 2 cards in
Posted 9 hours ago

Production Tech 1-2nd Shift

bioMerieux

•

Hazelwood, Missouri, USA

Full-time

Job DescriptionLow-cost medical, dental, and vision benefits starting day one 11 paid holidays 160 hours of paid time off Annual bonus 9.5% 401k company contribution with no vesting period Tuition reimbursement up to $10000 per calendar year Onsite cafeteria with daily food stipend Pay is $17.50-$19.50/hr based upon experience Position Summary: The Production Technician I position is responsible for the operation of high speed equipment used in the production and packaging of VITEK 2 cards in a
Posted 9 hours ago

Production Tech 1-1st Shift

bioMerieux

•

Hazelwood, Missouri, USA

Full-time

Job Description Low-cost medical, dental, and vision benefits starting day one 11 paid holidays 160 hours of paid time off Annual bonus 9.5% 401k company contribution with no vesting period Tuition reimbursement up to $10000 per calendar year Onsite cafeteria with daily food stipend Pay is $17.50-$19.50/hr based upon experience Position Summary: The Production Technician I position is responsible for the operation of high speed equipment used in the production and packaging of VITEK 2 cards in
Posted 9 hours ago

Lead Mechanical Engineer

Motion Recruitment Partners, LLC

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Boston, Massachusetts, USA

Full-time

Our client, an innovative diagnostic medical device company, is seeking a Lead Mechanical Engineer to join their team. This individual will play a critical role in leading the design, development, and refinement of mechanical systems for next-generation diagnostic products. The company is committed to transforming point-of-care diagnostics and is looking for someone who thrives in a collaborative, fast-paced environment. This is an excellent opportunity for an experienced mechanical engineer who
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Posted 48 days ago | Updated 4 hours ago

Network Analyst

Metasys Technologies

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Twinsburg, Ohio, USA

Contract

Network Analyst Twinsburg, OH (onsite)This position is intended to install, maintain, secure, and monitor HCUS s network and server infrastructure including related software. Responsible for testing and implementation of new technology. Also responsible for developing IT policies and procedures and assisting the help desk with complex calls.Fortinet Firewall 2 to 3 years of experience. Duties and Responsibilities Network and server installation, administration, maintenance, securing and monitori
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Posted 8 days ago | Updated 3 hours ago

Project Manager

Ace Technologies, Inc.

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Ewing Township, New Jersey, USA

Contract, Third Party

PROJECT MANAGER Role Summary The Project Manager is the single point of accountability for the delivery of one or more medium to large,complex business information technology projects involving multiple functions, delivering substantive value to business areas.This includes the structuring and detailed planning of the project work, management of the day-to-day work activities of the project, ensuring compliance to all applicable C&D processes, managing project scope, issues, risk, resources (int
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Posted 15 hours ago

Quality Control Analyst I

Sunrise Systems, Inc.

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Cincinnati, Ohio, USA

Contract

Job Title: Quality Control Analyst I Job ID: 25-09154 Location: Cincinnati, OH Temp to Perm: Temp to perm based on openings and performance Shift Schedule: Monday - Friday 8:00am - 5:00pm Core essential skill sets candidates must have to be considered for the role: 1. BS or higher in science related discipline, chemistry is preferred 2. Lab experience 3. Recent College graduates welcome TECHNICAL DUTIES AND RESPONSIBILITES: Loading/unloading scientific glassware in dishwasher according to writ
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Posted 20 days ago | Updated 14 hours ago

Senior Appian Developer

General Dynamics

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Gaithersburg, Maryland, USA

Full-time

Type of Requisition: Pipeline Clearance Level Must Currently Possess: None Clearance Level Must Be Able to Obtain: None Public Trust/Other Required: Other Job Family: Software Engineering Job Qualifications: Skills: Appian (Platform), Appian BPM, Appian Process Automation Certifications: Appian Level 1 Credential Certification - Appian Experience: 5 + years of related experience ship Required: No Job Description: General Dynamics Information Technology is seeking numerous candidatesto fi
Posted 52 days ago | Updated 9 hours ago