Senior Associate, Quality Systems

4 weeks ago

Framingham, United States Replimune, Inc. Full time
Overview

The Sr. Associate, Quality Systems, provides cross-functional support of GXP activities as they relate to Quality Systems. This position will participate in the improvement of Quality Systems to ensure quality and adherence with current Good Manufacturing Practice (cGMP) and inspection readiness.

This position is based in our Framingham, MA facility, and has a 4-5 day in office requirement per week.

Responsibilities

Key responsibilities:
  • Provide support of day-to-day operations of the Quality System department for multiple sites and support internal and external customers.
  • Participate in continuous improvement initiatives.
  • Review records and documents, for completeness and compliance with global regulations.
  • Generate standard operating procedures and/or guidelines to define and improve quality system functions.
  • Support and manage document lifecycle the Electronic Document Management System (EDMS).
  • Track and trend compliance paperwork (deviations, change controls, etc. both internal and external).
  • Oversee training documentation and compliance metrics through use of learning management system (LMS).
  • Assist with employee "on-boarding" training on general quality specific procedural requirements.
  • Ensure organizational charts are updated on a regular basis.
  • Participate in the internal audit program.
  • Create and modify user groups, training items, curricula, group trainings and assignments.
  • Conduct periodic review and audits of Quality Systems.
  • Assist with preparation of QMS metrics.
Qualifications

JOB REQUIREMENTS:
  • Highly motivated individual with excellent time management skills.
  • Strong organizational skills with the ability to effectively prioritize and manage multiple projects and tasks with attention to detail.
  • Ability to proactively resolve issues in a diplomatic, flexible, and constructive manner.
  • Proficient in Microsoft suite (Word, Excel, PowerPoint, Access and Outlook).
  • Excellent written and oral communication skills.
  • Ethical, self-motivated and self-directed.
Educational requirements:
  • Bachelor's degree with practical experience in a regulated manufacturing environment or equivalent experience
  • A minimum of 4 years of relevant experience required.


This position is based in our Framingham, MA facility, and has a 4-5 day in office requirement per week.

  • Senior Associate, Quality Systems

    6 days ago

    Framingham, United States Replimune, Inc. Full time

    Overview: The Sr. Associate, Quality Systems, provides cross-functional support of GXP activities as they relate to Quality Systems. This position will participate in the improvement of Quality Systems to ensure quality and adherence with current Good Manufacturing Practice (cGMP) and inspection readiness. This position is based in our Framingham, MA...

  • Senior Associate, Plant Quality Assurance

    4 days ago

    Framingham, United States Replimune, Inc. Full time

    Overview This Senior Associate PQA position is the primary QA resource during manufacturing production activities, providing real time quality oversight for Drug Substance, Drug Product, and all other production and QC testing activities. This position will be required to proactively support cGMP compliance and interact with all departments within the...

  • Senior Systems Validation Engineer

    2 days ago

    Framingham, United States Bose Full time

    The Senior Systems Validation Engineer (SVE) acts as the principal technical representative for validation activities, developing and executing the verification plans for all consumer electronics programs, ensuring that products are validated and cer Validation Engineer, Systems, Validation, Engineer, Senior, Mechanical, Manufacturing, Technology

  • Senior Electrical Engineer, Utility Scale Renewable and Energy Storage Systems

    2 months ago

    Framingham, Massachusetts, United States Ameresco, Inc. Full time

    Ameresco has an opportunity for a Senior Electrical Engineer. The Senior Electrical Engineer oversees the Technical Review of projects that include utility-scale renewable and energy storage assets. This is a remote position in the US with travel to project sites required.Responsibilities:Review contractual documents for performance requirements, standards,...

  • Food Service Director

    1 month ago

    Framingham, United States Benchmark Senior Living Full time

    Job Description The Branches of Framingham is looking for a passionate and skilled Director of Food Service! Joining the Benchmark Senior Living team means putting your passion to work. Our associates feel a sense of belonging with the care that they provide, empowered by the open and reliable team that surrounds them. Our diverse and skilled workforce...

  • Food Service Director

    2 weeks ago

    Framingham, United States Benchmark Senior Living Full time

    Job Description The Branches of Framingham is looking for a passionate and skilled Director of Food Service! Joining the Benchmark Senior Living team means putting your passion to work. Our associates feel a sense of belonging with the care that they provide, empowered by the open and reliable team that surrounds them. Our diverse and skilled workforce...

  • Quality Manager V

    3 weeks ago

    Framingham, United States PSG Global Solutions Careers Full time

    Apply now and our proprietary system will quickly have you in front of a live recruiter. The Opportunity Description We're looking for a Quality Manager V, working in Pharmaceuticals and Medical Products industry in 31 New York Avenue, Framingham, Massachusetts, 01701, United States. Participate in project teams involved in site biotech facilities, processes...

  • Research Associate

    1 month ago

    Framingham, United States Evotec SE Full time

    Cyprotex, an Evotec company, specializes in ADME-Tox and Biosciences including both in vitro (laboratory experiments) and in silico (computer modelling) approaches. Cyprotex was founded in 1999. The Company serves the Pharmaceutical and Biotech, Cosmetics/Personal Care and Chemicals Industries as well as academia and not-for-profit organizations. Over 1700...

  • Research Associate

    2 weeks ago

    Framingham, United States Evotec SE Full time

    Cyprotex, an Evotec company, specializes in ADME-Tox and Biosciences including both in vitro (laboratory experiments) and in silico (computer modelling) approaches. Cyprotex was founded in 1999. The Company serves the Pharmaceutical and Biotech, Cosmetics/Personal Care and Chemicals Industries as well as academia and not-for-profit organizations. Over 1700...

  • Research Associate

    1 month ago

    Framingham, United States Evotec Full time

    Cyprotex, an Evotec company, specializes in ADME-Tox and Biosciences including both in vitro (laboratory experiments) and in silico (computer modelling) approaches. Cyprotex was founded in 1999. The Company serves the Pharmaceutical and Biotech, Cosmetics/Personal Care and Chemicals Industries as well as academia and not-for-profit organizations. Over 1700...

  • Research Associate

    2 weeks ago

    Framingham, United States Evotec Full time

    Cyprotex, an Evotec company, specializes in ADME-Tox and Biosciences including both in vitro (laboratory experiments) and in silico (computer modelling) approaches. Cyprotex was founded in 1999. The Company serves the Pharmaceutical and Biotech, Cosmetics/Personal Care and Chemicals Industries as well as academia and not-for-profit organizations. Over 1700...

  • Senior Internal Controls Associate

    3 weeks ago

    Framingham, United States Definitive Healthcare, US Full time

    Job DescriptionJob DescriptionAt Definitive Healthcare, our passion is to transform data, analytics and expertise into healthcare commercial intelligence. We help clients uncover the right markets, opportunities and people, so they can shape tomorrow's healthcare industry. Our SaaS platform creates new paths to commercial success in the healthcare...

  • Senior Internal Controls Associate

    3 weeks ago

    Framingham, Massachusetts, United States Definitive Healthcare Full time

    At Definitive Healthcare, our passion is to transform data, analytics and expertise into healthcare commercial intelligence. We help clients uncover the right markets, opportunities and people, so they can shape tomorrow's healthcare industry. Our SaaS platform creates new paths to commercial success in the healthcare market, so companies can identify where...

  • Senior Internal Controls Associate

    2 weeks ago

    Framingham, Massachusetts, United States Definitive Healthcare Full time

    At Definitive Healthcare, our passion is to transform data, analytics and expertise into healthcare commercial intelligence. We help clients uncover the right markets, opportunities and people, so they can shape tomorrow's healthcare industry. Our SaaS platform creates new paths to commercial success in the healthcare market, so companies can identify where...

  • Senior Project Development Engineer

    3 weeks ago

    Framingham, United States Russell Tobin & Associates Full time

    What are we looking for in our Senior Project Development Engineer? RussellTobin is looking for Senior Project Development Eng. for one of our a leading cleantech integrator and renewable energy asset developer, owner and operator in Framingham, MA (Remote). It's a permanent/direct-hire opportunity. Apply today for consideration !Senior...

  • Senior Electrical Engineer

    10 hours ago

    Framingham, United States Bose Professional Full time

    Company Overview: Bose Professional is a leader in the professional audio industry, specializing in the design and manufacturing of cutting-edge audio solutions including loudspeakers, amplifiers, signal processing devices, controls, software, and accessories. We create sound systems for Restaurants, Retail, Houses of Worship, and Live Performance Venues to...

  • Senior Project Development Engineer

    3 weeks ago

    Framingham, United States Russell Tobin Full time

    Job DescriptionJob DescriptionRussellTobin is looking for Senior Project Development Eng. for one of our a leading cleantech integrator and renewable energy asset developer, owner and operator in Framingham, MA (Remote). It's a permanent/direct-hire opportunity. Apply today for consideration !Senior Project Development Eng.Framingham, MA 01701, US...

  • Global LMS Specialist

    3 days ago

    Framingham, United States Connexion Systems & Engineering, Inc. Full time

    Job DescriptionJob DescriptionJob Title: Global LMS SpecialistPay Rate: $35.00-$40/hr.Location: Framingham, MADuration: Approved until 9/27/24Hours: M-F typical schedule is 7am - 4pm or 8am - 5pm EST.Notes: Pay Range $35-40/hourRemote, but must be available to work EST hours, typical schedule is 7am - 4pm or 8am - 5pm EST. Mat leave coverage.Seeking...

  • Senior Electrical Engineer

    2 days ago

    Framingham, United States Bose Professional Full time

    Job DescriptionJob DescriptionCompany Overview: Bose Professional is a leader in the professional audio industry, specializing in the design and manufacturing of cutting-edge audio solutions including loudspeakers, amplifiers, signal processing devices, controls, software, and accessories. We create sound systems for Restaurants, Retail, Houses of Worship,...

  • Quality Engineer

    1 month ago

    Framingham, United States Sofregen Inc. Full time

    Sofregen Medical is an emerging medical device company founded in 2014. Sofregen Medical is focused on leveraging the silk protein as a biomaterial for medical applications. Our mission is to provide our patients with a fresh start, restore confidence, and improve their quality of life. Please visit our website at www.sofregenmedical.com for more details on...