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Quality Assurance Specialist
5 days ago
Element Materials Technology Acton, United StatesOverview: · Element Materials Technology Boston-Acton, Inc. is looking for a full-time **Quality Assurance Specialist** to support the Quality Assurance Unit in a cGMP Microbiology Laboratory · **Responsibilities**: · - Comply with current Good Manufacturing Practice regulations, ...
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Quality Assurance Specialist
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The Arc of Opportunity Fitchburg, United StatesProvides administrative and clerical support for quality assurance functions by preparing reports and other necessary information. Supports the electronic file management system (iCentrix) system for all individuals served. Acts as the primary person responsible for day-to-day ma ...
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Quality Assurance Specialist
1 week ago
Axiomtek Methuen, United States**JOB BRIEF** · The position QA Specialist manages and maintains the database for the quality management system, prepares and presents quality trending reports, provides input to QA Manager and/or Team Leader on team member performance, maintains quality assurance documents and c ...
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Quality Assurance Specialist
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DPS Group Boston, United StatesADPS Group is seeking a Quality Assurance Specialist to support leading and owning risk assessments in support of change controls and deviations. The scope of work will require writing risk assessment documents and holding stakeholder meetings to progress risk assessments and obt ...
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Quality Assurance Specialist
2 weeks ago
DPS Group TSO Boston, United States**Summary** · ADPS Group is seeking a Quality Assurance Specialist to support leading and owning risk assessments in support of change controls and deviations. The scope of work will require writing risk assessment documents and holding stakeholder meetings to progress risk asses ...
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Quality Assurance Specialist I
2 days ago
Avantor Devens, United StatesThe Opportunity:Avantor is looking for a detail-centric Quality Assurance Specialist I to join our Quality Assurance Specialist team. Our Quality Assurance Specialist Team upholds and maintains Avantors operational continuity, including documentatio Quality Assurance, Assurance, ...
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Quality Assurance Specialist I
2 days ago
Avantor Devens, United StatesThe Opportunity: · Avantor is looking for a detail-centric Quality Assurance Specialist I to join our Quality Assurance Specialist team. Our Quality Assurance Specialist Team upholds and maintains Avantor's operational continuity, including documentation ownership by maintaining ...
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Contract - Quality Assurance Specialist, Cmc
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Vedanta Biosciences Cambridge, United States**Title: Contract - Quality Assurance Specialist, CMC** · **Location: Cambridge, MA and Acton, MA** · **Reports to: Supervisor, Quality Assurance** · **About Vedanta Biosciences**: · **The Role**: · The QA CMC Specialist is responsible for performing a wide variety of activities ...
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Production Control Support Specialist
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Commonwealth Fusion Systems Devens, United StatesAs a member of the CFS Supply Chain Team you will be responsible for assisting in meeting company objectives by keeping the production line flowing with inventory and material movement. You will be responsible for ensuring orderly and safe distribution of inventory and tooling ar ...
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Quality Assurance Specialist
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ClinLab Staffing Lowell, United StatesQA Specialist · Location: Lowell, MA · Summary of Primary Responsibilities: · The Quality Assurance (QA) Compliance Specialist performs compliance activities in support of production and engineering ensuring all activities are performed according to internal Quality System requir ...
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Quality Assurance Specialist
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Kinefac Corporation Worcester, United StatesQuality Assurance Specialist & Quality Control Engineer · Kinefac is a world leader in precision metal forming and processing technology providing innovative solutions to customers in the automotive, aerospace, medical, power generation and other industries. The company develops ...
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Quality Assurance Specialist
2 days ago
ClinLab Staffing Lowell, United StatesQA Specialist · Location: Lowell, MA · Summary of Primary Responsibilities: · The Quality Assurance (QA) Compliance Specialist performs compliance activities in support of production and engineering ensuring all activities are performed according to internal Quality System req ...
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Quality Assurance Specialist
2 days ago
Voyager Therapeutics, Inc. Cambridge, United StatesThe Quality Assurance Specialist will actively contribute to the implementation and maintenance of the Quality Systems Manual and conduct GMP compliance audits as directed. The QA Specialist will have oversight of and involvement in, GMP compliance for production of Clinical Tria ...
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Quality Assurance Specialist
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Spectraforce Technologies Worcester, United StatesPosition Title: · Quality Assurance Specialist III · Length of Contract: 12 months · Location/Site: · Worcester, MA · Hybrid Onsite Schedule: Hybrid · Job Description: · Regulatory Compliance & Quality Systems Specialist / Sr. Specialist - looking for 2-3 staff in this are ...
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Quality Assurance Specialist
5 days ago
Cynet Systems Newton, United StatesJob Description · Job DescriptionWe are looking for Quality Assurance Specialist for our client in Newton, MA · Job Title: Quality Assurance Specialist · Job Location: Newton, MA · Job Type: Contract · Job Description: · Pay Range: $27.29hr - $32.29hr · Disposition of non-conform ...
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Quality Assurance Specialist
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TBH Recruitment Co. Weston, United StatesJob Description · Job DescriptionQuality Assurance Specialist · Vanguard Renewables is the premier anaerobic digester developer/owner/operator in the United States. Our closed-loop anaerobic digestion process converts organic waste and cow manure into green electricity or renewab ...
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Quality Assurance Specialist
2 days ago
Cynet Systems Newton, United StatesPreferred Knowledge, Skills, Education, and Experience: · Prior Medical Device/Biotech experience. · Prior experience with a Document Control Platform such as Arena or Agile. · Ability to work semi-independently within a regulated environment. · ...
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Quality Assurance Specialist
2 days ago
Axiomtek Methuen, United StatesJob Description · Job Description Salary: · JOB BRIEF · The position QA Specialist manages and maintains the database for the quality management system, prepares and presents quality trending reports, provides input to QA Manager and/or Team Leader on team member performance, ...
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Quality Assurance Specialist
2 days ago
Spectraforce Technologies Worcester, United StatesTitle -- QA Specialist · Duration -- 6 months · Location/Site - Worcester, MA · Job Description · 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, M ...
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Quality Assurance Specialist
1 week ago
Orion Group Worcester, United StatesQuality Assurance Specialist · $27 - $30 per hour with option for medical benefits. · 6 month initial contract · Worcester, MA · Standard first shift · Orion Group and a market leading pharmaceutical company are seeking Quality Assurance Specialists in Worcester ASAP Our client i ...
Quality Assurance Specialist - Ayer, United States - Axelon Services Corporation
Description
Job Description: Field QA Specialist
Devens, MA
This role is 100% on-site.
Work Schedule: Mon - Fri, 2PM - 10:30 PM EST
Training Shift : This is weeks on 1st shift which is 7AM - 3:30PM Mon - Fri
JOB SUMMARY
Client is seeking a Contractor Field QA Specialist for the QA Operations organization at the Single Use Facility (SUF) in Devens, MA. The Contractor Field QA Specialist is responsible for quality activities for the Single Use Facility in accordance with *** policies, standards, procedures, and Global cGMP. Functional responsibilities include ensuring manufacturing compliance with applicable procedures and batch records, providing real time review of manufacturing batch record documentation and logbooks, and working with operations to resolve manufacturing issues. The Contractor Field QA Specialist role is stationed in Devens, MA and reports to the Senior Manager of QA Operations for the Devens SUF.
This role is Monday through Friday 2pm - 10:30pm
JOB RESPONSIBILITIES
Perform QA on the floor activities.
Ensure manufacturing compliance with applicable procedures and batch records.
Perform real time review of manufacturing batch records.
Review manufacturing shop floor documentation.
EDUCATION REQUIREMENTS
High School Degree required
Relevant college or university degree preferred.
Minimum 4 years relevant work experience, with experience in a Quality Assurance role.
QUALIFICATIONS REQUIRED
Equivalent combination of education and experience is acceptable.
Must be action-oriented and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
Understands continuous improvement and improves efficiency and productivity within the group or project.
Builds relationships internally within and with cross functional teams.
Must have sound knowledge and experience in FDA regulated cGMP warehousing, Quality, and compliance environments. Prefer to also have knowledge of GMP Manufacturing operations and processes.
Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.
Routinely recognizes and resolves Quality issues; Informs management of proposed solutions. Seeks management guidance on complex issues.
Able to recognize conflict and notify management with proposed recommendations for resolution.
Must possess an independent mindset. Work is self-directed.
Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision.
Confident in making decisions for non-routine issues.
Develops and revises procedures.
Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution.
Able to prepare written communications and communicate problems to management with clarity and accuracy.
Able to effectively multi-task.
Knowledge of US and global cGMP requirements.
Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
Must be skilled in planning and organizing, decision-making, and building relationships.
Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management.
Able to effectively multi-task.
Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality Risk Management principles.
Must be skilled in planning and organizing, decision-making, and building relationships.
Knowledge of quality processes, change control, product complaints, deviations, investigations, and CAPA management.
