Talent.com
Quality Assurance Specialist II, Manufacturing Quality Assurance (Fri - Mon)
Quality Assurance Specialist II, Manufacturing Quality Assurance (Fri - Mon)Nitto Denko • Milford, MA, United States
Quality Assurance Specialist II, Manufacturing Quality Assurance (Fri - Mon)

Quality Assurance Specialist II, Manufacturing Quality Assurance (Fri - Mon)

Nitto Denko • Milford, MA, United States
30+ days ago
Job type
  • Full-time
Job description

About this opportunity :

The Quality Assurance Specialist, Manufacturing Quality Assurance is responsible for overseeing manufacturing batches and operational support activities that are on-going daily. This is a first shift position (Fri-Mon) and comes with a 10% shift differential.

Key Responsibilities :

  • Executes daily line clearance and oversees manufacturing activities by utilizing general area QA oversight checklists.
  • Assist with production and QC to provide Good Manufacturing and Laboratory Practices.
  • Understand and execute MQA responsibilities that are defined in SOP.
  • Monitoring manufacturing operations including cleaning by conducting reviews of logbooks.
  • Escalate detected major issues on the floor to MQA and QA management.
  • Review facility cleaning, material transfers and personnel hygiene control.
  • Providing quality oversight to critical building management system (BMS) alarms, preventive maintenance (reactive work orders), and calibration (out of tolerance).
  • Based on outcomes of QMRs, quality council, internal and external audit findings, and QA operational (e.g., MQA) findings identify, propose and lead continuous improvement projects.
  • Provide Quality oversight and compliance guidance on new building program initiatives.
  • Train, motivate, monitor, and lead quality teams through necessary change.

Required Skills / Abilities :

  • At least 3 years' experience in a regulated / GMP industry required, with experience in Pharmaceuticals or Biotechnology preferred.
  • Understanding of 21 CFR 210, 21 CFR 211, and ICH Q7 regulations.
  • Ability to work in a fast-paced environment consisting of internal and external team members with minimal oversight.
  • Problem-solving skills with the ability to adapt to changing priorities and timelines.
  • Ability to build positive working partnerships with other department teams.
  • Experienced in the use of electronic systems such as eQMS.
  • Prior experience with clinical and commercial manufacturing is preferred.
  • Requires the ability to gown into clean rooms and wear PPE.
  • The annualized salary range for this role is $67,900.00 - $83,100.00

    Create a job alert for this search

    Quality Assurance Specialist • Milford, MA, United States

    Related jobs
    Quality Assurance Tech II (Hardware) : 24-02495

    Quality Assurance Tech II (Hardware) : 24-02495

    Akraya Inc • Westborough, Massachusetts, United States
    Full-time
    Quick Apply
    Troubleshooting, Quality Assurance, Testing Hardware, Linux , Unix, SQL.A leading FAANG E-Commerce company is looking for a test technician who is responsible for conducting various tests on roboti...Show more
    Last updated: 30+ days ago
    Automation Engineer II

    Automation Engineer II

    Ken's Foods • Marlboro, MA, US
    Full-time
    Ken’s Foods is a family owned business that takes pride in its roots.Ken's Foods, Inc was incorporated in 1958, and currently has plant operations in Marlborough, Massachusetts, McDonough, Georgia,...Show more
    Last updated: 30+ days ago • Promoted
    Quality Systems Engineer- Self Inspection & Audit / Inspection Readiness - Now Hiring!

    Quality Systems Engineer- Self Inspection & Audit / Inspection Readiness - Now Hiring!

    Astellas • Westborough, MA, United States
    Full-time
    Quality Systems Engineer- Self Inspection & Audit / Inspection Readiness.Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven ...Show more
    Last updated: 10 days ago
    Quality Manager

    Quality Manager

    Consigli Construction • Milford, MA, US
    Full-time
    Quick Apply
    Regional Quality Manager .The Quality Manager (QM) will collaborate with several project teams throughout the lifecycle of their assigned projects. Their main responsibility is to support and b...Show more
    Last updated: 24 days ago
    Policy and Claims Research Specialist

    Policy and Claims Research Specialist

    Neighborhood Health Plan of Rhode Island • Smithfield, RI, United States
    Full-time
    Smithfield, RI - Smithfield, RI.The Policy and Claims Research Specialist.Payment Integrity initiatives and projects.This role will act as the point of contact for claim related research.Serves as ...Show more
    Last updated: 30+ days ago • Promoted
    Compliance Specialist

    Compliance Specialist

    Crystal Equation Corporation • Westborough, MA, US
    Full-time
    The Compliance Specialist CMC, Quality Assurance.The Compliance Specialist CMC, Quality Assurance will perform critical QA tasks in support of GMP and non-GMP manufacturing programs and Regulatory ...Show more
    Last updated: 10 hours ago • Promoted • New!
    QA Associate

    QA Associate

    AbbVie • Worcester, Massachusetts, USA
    Full-time
    The Quality Associate supports the Quality Function that they are responsible for within Operations.This could include : Incoming Quality Assurance of drugs and packaging materials Manufacturing Qua...Show more
    Last updated: 16 days ago • Promoted
    Medical Device QMS Auditor

    Medical Device QMS Auditor

    BSI Group • Worcester, Massachusetts, USA
    Full-time
    We exist to create positive change for people and the planet.Join us and make a difference too!.Location : Must be located in the US (NJ MA PA OH). Do you believe the world deserves excellence.BSI (B...Show more
    Last updated: 4 hours ago • Promoted • New!
    Quality Manager

    Quality Manager

    bostonscientific • Coventry, Rhode Island, USA
    Full-time
    Diversity - Innovation - Caring - Global Collaboration - Winning Spirit- High Performance.At Boston Scientific well give you the opportunity to harness all thats within you by working in teams of d...Show more
    Last updated: 20 days ago • Promoted
    Calibration Specialist III

    Calibration Specialist III

    The Fountain Group • Worcester, MA, United States
    Temporary
    The Fountain Group is currently seeking an.Details for the position are as follows : .Job Title : Calibration Technician. Duration : 6-month contract (high potential to convert to Perm).Accurately and c...Show more
    Last updated: 19 days ago • Promoted
    Food Safety Quality Assurance Manager

    Food Safety Quality Assurance Manager

    GPAC • Worcester, MA, US
    Full-time
    Food Safety Quality Assurance Manager.Gpac is working with an award-winning family-owned growing food manufacturer in north central Massachusetts that is seeking Food Safety Quality Assurance Manag...Show more
    Last updated: 1 hour ago • Promoted • New!
    Quality Lab Manager

    Quality Lab Manager

    Hutchinson Aerospace & Industry • Hopkinton, MA, United States
    Full-time
    As the Quality Lab Manager, you will be at the forefront of our commitment to excellence.You will lead a talented team of Quality Technicians and Mechanical Inspectors in ensuring that all products...Show more
    Last updated: 30+ days ago • Promoted
    Quality Assurance Senior Associate

    Quality Assurance Senior Associate

    Aequor • West Greenwich, RI, US
    Full-time
    Night shift add 15% differential.Maximum supplier rate is • • • Candidates who have previously worked a night shift schedule would be nice to have. Onsite 100% - 12-hour night shifts (7 : 00 PM - 7 : 00 A...Show more
    Last updated: 30+ days ago • Promoted
    Quality Manager

    Quality Manager

    Element • Boxborough, MA, US
    Full-time
    Element has an opportunity for an experienced quality professional to join its team as a Quality Manager over-seeing the quality systems of Boxborough, Ma. Pittsfield, Ma; and Montreal, Quebec.Sala...Show more
    Last updated: 30+ days ago • Promoted
    Travel CT Tech in Woonsocket, RI

    Travel CT Tech in Woonsocket, RI

    AlliedTravelCareers • Woonsocket, RI, US
    Full-time +1
    AlliedTravelCareers is working with Lancesoft Inc.CT Tech in Woonsocket, Rhode Island, 02895!.We are currently seeking qualified candidates for CT Technologist. Shift 4 - 10 Nights, 18 : 00 : 00-04 : 00 : 0...Show more
    Last updated: 30+ days ago • Promoted
    QA Compliance Specialist (Data Review)

    QA Compliance Specialist (Data Review)

    Careers Integrated Resources Inc • Westborough, MA, US
    Full-time
    Job Title : QA Compliance Specialist (Data Review).The Compliance Specialist CMC, Quality Assurance will perform critical QA tasks in support of GMP and non-GMP manufacturing programs and Regulatory...Show more
    Last updated: 1 day ago • Promoted
    Calibration Tech II

    Calibration Tech II

    Boston Scientific • Marlborough, MA, United States
    Full-time
    Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance.At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams ...Show more
    Last updated: 26 days ago • Promoted
    Quality Inspector

    Quality Inspector

    Talnt • Worcester, Massachusetts, United States
    Full-time
    Quick Apply
    We are seeking a Quality Inspector to join our manufacturing team in Worcester, MA.The Quality Inspector will use precision measurement tools, conduct First Article Inspections, and maintain accura...Show more
    Last updated: 30+ days ago