Jobs
>
Cambridge

    Compliance Specialist - Cambridge, United States - LanceSoft

    LanceSoft
    LanceSoft Cambridge, United States

    2 weeks ago

    Default job background
    Description
    Role: Compliance Specialist - Level 2
    Location: Cambridge, MA, 02142
    Duration: It is a contract for 12 months (but we are looking to make it full time if the contractor performs well.)
    On Site Position

    Shift: 1st shift hours (flexible with times)

    Description:
    • Will work closely within the Manufacturing Compliance group to achieve department goals.
    • The Compliance Specialist is also responsible for owning and driving manufacturing compliance improvement through deviation resolution, applied root cause analysis and the application of CAPA to elevate safety, quality, cost, on-time delivery, and right first-time performance.
    • The Compliance Specialist supports by working cross-functionally with internal support departments to drive improvements to completion.
    Key Responsibilities:
    • Lead event investigations to adequately identify root cause and implement appropriate corrective and preventative actions to prevent reoccurrence,
    • Lead CAPA investigations and at times manage the implementation of CAPA.
    • Own manufacturing related change controls.
    • Responsible for organizing data and preparing appropriate documentation, including presenting materials, for assigned projects.
    • Recommending batch record and SOP improvements to reduce or eliminate GDP errors or correct root causes of deviations.
    • Review production documentation and perform quality walk-throughs during manufacturing events
    • Participate in continuous improvement teams such as 5s, Gemba and the Client's Production Systems (GPS).
    • Provide training and guidance to team members on compliance-related matters to promote a culture of compliance throughout the organization.
    • Lead team meetings and facilitate multidepartment discussions.
    • Stay current with biopharmaceutical industry best practices and technologies.
    • Other duties as assigned.
    Basic Qualifications:
    • We are looking for professionals with these required skills to achieve our goals:
    • Bachelor's degree or equivalent experience.
    • 3+ years of related experience.
    • Demonstrated knowledge of cGMP manufacturing with knowledge in manufacturing operations in downstream processing utilizing single use technology (SUT).
    • Experienced with standard troubleshooting approaches (problem statement, root cause analysis, Ishikawa (fishbone diagram), 5 Whys).
    • Good computer skills, knowledge of Microsoft office products - Word, Excel, Office.
    • Collaborate with cross-functional teams to integrate compliance measures into various aspects within manufacturing operations.
    • Ability to meet schedule is required; this position may infrequently include shift, weekend, or holiday work and overtime as dictated by a 365-day production schedule.
    • Ability to work in a cleanroom environment and comply with hygiene standards and use of clean room gowning.
    • This job is on-site M-F at Binney Street in Cambridge. There is limited ability to work from home.
    Preferred Qualifications:
    • If you have the following characteristics, it would be a plus:
    • SME or experienced with some or all of the following process equipment; homogenizers, tangential flow filtration (TFF), ultrafiltration/diafiltration (UFDF), Single use technology (SUT), buffer preparation and filtration.
    • Experience with regulatory agency interactions and inspection discussions preferred but not required.
    • Excellent verbal/written communication skills.
    • Facilitation and demonstration skills
    • Attention to detail and the ability to work individually and within multi-disciplinary teams
    • More advanced knowledge / proficiency with business software (i.e. Excel, Visio) and industry systems (LIMS, ERP, SAP)
  • LexisNexis Risk Solutions

    Compliance Specialist I

    2 weeks ago

    LexisNexis Risk Solutions Cambridge, United States

    **Essential Job Functions**:This job description indicates the general level and nature of work expected of the incumbent. It is not a comprehensive list of specific duties or activities associated with the position. The incumbent may be asked to perform other duties as assigned. ...

  • Boston Public Health Commission

    Compliance and Credentialing Specialist

    2 days ago

    Boston Public Health Commission Boston, United States

    The mission of the Boston Public Health Commission (BPHC) is to work in partnership with communities to protect and promote the health and well-being of all Boston residents, especially those impacted by racism and systemic inequities. The BPHC envisions a thriving Boston where a ...

  • C3 Industries

    Retail Compliance Specialist

    1 day ago

    C3 Industries Boston, United States

    JOB SUMMARY: · The Retail Compliance Specialist is responsible for ensuring that assigned retail stores are operating in compliance with state and local ordinances, rules and regulations. · JOB DUTIES: · Core duties and responsibilities include the following. Other duties may be ...

  • Randstad North America, Inc.

    Compliance Specialist

    1 week ago

    Randstad North America, Inc. Cambridge, United States

    Exciting new opportunity for an experienced Compliance Specialist who will work closely within the Manufacturing Compliance group to achieve department goals. The Compliance Specialist is also responsible for owning and driving manufacturing complian Compliance Specialist, Compli ...

  • Alphanumeric Systems

    Compliance Specialist

    1 week ago

    Alphanumeric Systems Cambridge, United States

    Alphanumeric is hiring a COMPLIANCE SPECIALIST to work in Cambridge, MA with our client of 20 years committed to improving lives through medical and pharmaceutical advancements. · We have an exciting new opportunity for an experienced Compliance Specialist who will work closely w ...

  • eTeam

    Compliance Specialist

    3 weeks ago

    eTeam Cambridge, United States

    Title: Compliance Specialist - Level 2 · Location:- Cambridge, MA · Duration - 12 months, but we are looking to make it full-time if the contractor performs well** · Hybrid Remote · Pay Rate Range:- $61.42 on w2 · ***Candidate MUST have a MFG background*** · Shift = 1st shi ...

  • Randstad North America, Inc.

    Compliance Specialist

    6 days ago

    Randstad North America, Inc. Cambridge, United States

    As a Quality Systems Specialist, you will be responsible for providing effective and efficient support to the Quality Management Systems (QMS) team by maintaining compliance with company policies, QMS standards, and local regulations. You will report Compliance Specialist, Compli ...

  • Alphanumeric Systems

    Compliance Specialist

    2 days ago

    Alphanumeric Systems Cambridge, United States

    Alphanumeric is hiring a Quality Systems Specialist to work in Cambridge, MA with our client of 20 years committed to improving lives through medical and pharmaceutical advancements. · POSITION TITLE: Quality Systems Specialist · ON SITE - 9am-5pm / Monday - Friday · PAY - $52.35 ...

  • Randstad USA

    Compliance Specialist

    2 weeks ago

    Randstad USA Cambridge, United States Freelance, Full time

    job summary: · Exciting new opportunity for an experienced Compliance Specialist who will work closely within the Manufacturing Compliance group to achieve department goals. The Compliance Specialist is also responsible for owning and driving manufacturing compliance improvement ...

  • Randstad

    compliance specialist

    3 weeks ago

    Randstad Cambridge, United States

    compliance specialist - level 2 us- first shift. · + cambridge , massachusetts · + posted 2 days ago · **job details** · summary · + $55 - $58.70 per hour · + contract · + bachelor degree · + category life, physical, and social science occupations · + reference48012 · job details ...

  • Randstad

    compliance specialist

    4 weeks ago

    Randstad Cambridge, United States

    compliance specialist - level 2 us- first shift. · + cambridge , massachusetts · + posted 1 day ago · **job details** · summary · + $55 - $58.70 per hour · + contract · + bachelor degree · + category life, physical, and social science occupations · + reference48012 · job details ...

  • LanceSoft

    Compliance Specialist

    4 days ago

    LanceSoft Cambridge, United States

    POSITION TITLE: Quality Systems Specialist · ON SITE - 9am-5pm / Monday - Friday · As a Quality Systems Specialist, you will be responsible for providing effective and efficient support to the Quality Management Systems (QMS) team by maintaining compliance with *** policies, QM ...

  • Randstad

    Compliance specialist

    4 days ago

    Randstad Cambridge, United States

    job summary: · As a Quality Systems Specialist, you will be responsible for providing effective and efficient support to the Quality Management Systems (QMS) team by maintaining compliance with company policies, QMS standards, and local regulations. You will report to the QMS Man ...

  • The RMR Group

    Operations Compliance Specialist

    3 weeks ago

    The RMR Group Newton, United States

    Overview: · The Operations Compliance Specialist ensures the accuracy and compliance of all Service Contracts/Service Orders, Construction Contracts, Certificates of Insurance as well as the Building Engines - CMMS (Work Order) System control. The Operations Compliance Specialist ...

  • CommTank, Inc.

    Osha Compliance Specialist

    2 days ago

    CommTank, Inc. Wakefield, United States

    Job Overview: · We are seeking a skilled and detail-oriented Compliance Officer to join our team. As a Compliance Officer, you will be responsible for ensuring that our organization complies with all relevant regulations and standards. This role requires a strong understanding of ...

  • Randstad Life Sciences US

    Compliance Specialist II

    3 weeks ago

    Randstad Life Sciences US Cambridge, United States

    Job Description · This exciting new opportunity for an experienced Compliance Specialist who will work closely within the Manufacturing Compliance group to achieve department goals. The Compliance Specialist is also responsible for owning and driving manufacturing compliance imp ...

  • The Accuro Group

    Manufacturing Compliance Specialist

    2 weeks ago

    The Accuro Group Cambridge, United States

    Business Title: | Manufacturing Compliance Specialist Location: Cambridge, MA 02142 Job Type: Contract (12 Months) Note: Parking will not be reimbursed by the CLIENT. Parking is roughly $420/mo. Important: MFG background is mandatory. Job Description: THE CLIENT is a global bioph ...

  • Randstad Life Sciences US

    Compliance Specialist II

    1 week ago

    Randstad Life Sciences US Cambridge, United States

    Job Description · This exciting new opportunity for an experienced Compliance Specialist who will work closely within the Manufacturing Compliance group to achieve department goals. The Compliance Specialist is also responsible for owning and driving manufacturing compliance imp ...

  • Randstad Life Sciences US

    Compliance Specialist II

    6 days ago

    Randstad Life Sciences US Cambridge, United States

    Job Description · This exciting new opportunity for an experienced Compliance Specialist who will work closely within the Manufacturing Compliance group to achieve department goals. The Compliance Specialist is also responsible for owning and driving manufacturing compliance imp ...

  • RELX Group

    Compliance Specialist I

    1 week ago

    RELX Group Cambridge, United States

    About the Business · LexisNexis Risk Solutions is the essential partner in the assessment of risk. Within our Business Services vertical, we offer a multitude of solutions focused on helping businesses of all sizes drive higher revenue growth, maximize operational efficiencies, a ...