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Jobs at Allentown, LLC (Now Hiring) — 8 open

Allentown, LLC logoAllentown, LLC

Quality Specialist-Sterilization Operations

Branchburg Township, New Jersey, United States · On-site

$80k–$95k/yr

Senior

JOB SUMMARY The Quality Specialist is responsible for supporting and maintaining the Quality Management System (QMS) for medical device, pharma and combination device sterilization operations. This role is responsible fo…

Skills: Quality Management System, Change Control, SOP Creation, Incoming Inspection, Regulatory Compliance

Allentown, LLC logoAllentown, LLC

Vivarium Design Project Engineer

Allentown, New Jersey, United States · On-site

$75k–$85k/yr

Mid level

JOB SUMMARY The Project Engineer role serves as the primary contact between customers, internals teams and third-party providers. This role is responsible for managing and supporting the overall expectations of a project…

Skills: Project Management, Mechanical Engineering, AutoCAD, Solid Works, Revit

Allentown, LLC logoAllentown, LLC

Service & Technical Support Administrator

Allentown, New Jersey, United States · On-site

$50k–$60k/yr

Mid level

JOB TITLE: Service & Technical Support Administrator FLSA STATUS: Exempt JOB TYPE: Full-time JOB SUMMARY The Service and Technical Support Administrator reports to the Global Service Business Operations Manager and will …

Skills: Verbal Communication, Written Communication, Technical Proficiency, Multitasking, Priority Management

Allentown, LLC logoAllentown, LLC

FLO-VENT ASSEMBLERS

Allentown, New Jersey, United States · On-site

$18/hr–$20/hr

Entry level

JOB TITLE: Assembler FLSA STATUS: Non-exempt JOB TYPE: Full-time DEPARTMENT: Flovent - 515 REPORTS TO: Manager JOB SUMMARY The Assembler will be performing light assembly work with plastic and sheet metal parts. PRIMARY …

Skills: Mechanical Ability, Hand Tools, Screw Guns, Air Tools, Pop-riveter

Allentown, LLC logoAllentown, LLC

Engineering Technician

Branchburg Township, New Jersey, United States · On-site

$60k–$70k/yr

Senior

JOB TITLE: Engineering Technician FLSA STATUS: Exempt JOB TYPE: Full-time 100% On-Site attendance DEPARTMENT: Engineering REPORTS TO: Engineering Manager JOB SUMMARY The Engineering Technician is responsible for independ…

Skills: Engineering Design, Project Management, Solid Works, AutoCAD, cGMP

Allentown, LLC logoAllentown, LLC

Quality Assurance Technician-ClorDiSys

Branchburg Township, New Jersey, United States · On-site

$27/hr–$30/hr

Mid level

JOB TITLE: Quality Assurance Technician FLSA STATUS: Non-Exempt JOB TYPE: Full-time 100% On-Site attendance DEPARTMENT: Regulatory Affairs and Quality Assurance REPORTS TO: Senior Quality Engineer JOB SUMMARY The QA Tech…

Skills: Sterilization Process Review, Quality Assurance, Regulatory Compliance, Documentation Review, Process Verification

Allentown, LLC logoAllentown, LLC

Field Service Technician-Southern California

Allentown, New Jersey, United States · On-site

$80k–$90k/yr

Mid level

JOB TITLE: VDS+ Service Technician FLSA STATUS: Non-Exempt JOB TYPE: Full-time JOB SUMMARY The Service Technician provides In-Field Service Support with regional and national focus. Builds and maintains excellent busines…

Skills: Technical Support, Equipment Installation, Preventative Maintenance, Spare Parts Management, PLC Controls Diagnosis

Allentown, LLC logoAllentown, LLC

DECON Service Technician

Allentown, New Jersey, United States · On-site

$65k–$70k/yr

Mid level

JOB TITLE: Decon+ Field Service Technician FLSA STATUS: Non-Exempt JOB TYPE: Full-time DEPARTMENT: Decon+ REPORTS TO: Decon+ JOB SUMMARY Join our team as a Service Technician supporting cutting-edge decontamination and e…

Skills: Electromechanical Systems, Electrical Diagnosis, PLC Controls, Troubleshooting, Decontamination Systems

Allentown, LLC logo

Quality Specialist-Sterilization Operations

Allentown, LLC

Branchburg Township, New Jersey, United States • On-site

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Senior

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  • $80k–$95k/yr
  • Full-time
  • bachelor degree, professional certificate
  • Posted 5d ago
  • ~40 hrs/week

Responsibilities

The Quality Specialist maintains the Quality Management System for sterilization operations, managing change control, SOPs, and training programs. They collaborate across departments to ensure compliance with FDA and ISO regulatory standards.

Requirements

Requires a Bachelor's degree in engineering or science and 3-7 years of GMP quality experience, preferably in contract sterilization. A Certified Quality Engineer (CQE) credential or equivalent qualification is mandatory.

Full job description

 

JOB SUMMARY

The Quality Specialist is responsible for supporting and maintaining the Quality Management System (QMS) for medical device, pharma and combination device sterilization operations. This role is responsible for managing the change control process, creating and updating standard operating procedures, managing the training, approved supplier list and incoming inspection processes while maintaining regulatory compliance. The Quality Specialist collaborates with Quality, Operations, Validation, R&D and Engineering to ensure project work meets the applicable regulatory standards, customer specifications and applicable FDA regulations (QMSR, CFR 210 and CFR 211, ISO 13485 and ISO 14971).

 This position requires deep expertise in quality engineering within a GMP environment and the ability to independently evaluate complex situations to drive effective problem-solving. The Quality Specialist is expected to demonstrate strong professionalism, communication skills and the ability to manage multiple priorities in a fast-paced environment. A Certified Quality Engineer (CQE) credential or equivalent qualification is required. The role demands reliability, a strong work ethic and a positive, collaborative approach while maintaining ownership.

 

PRIMARY FUNCTIONS

  1. Manage the change control process including creating the ECO documentation, SOP redlines, SOP updates, SOP creation and approval.
  2. Manage the company wide training program.
  3. Certify and recertify the employees with the company quality policies and procedures.
  4. Manage the approved supplier list and company distribution.
  5. Manage the incoming inspection process.
  6. Achieve established productivity and quality performance goals while supporting operational excellence. 
  7. Adhere to all safety rules, quality standards, and company policies and procedures.
  8. Perform all assigned tasks in a safe, efficient and productive manner.
  9. Execute additional responsibilities, as assigned to support departmental and organizational objectives. 

KNOWLEDGE, SKILLS & QUALIFICATIONS

  1. Bachelor's degree in engineering or related scientific discipline or equivalent experience.
  2. 3–7 years of Quality experience in a GMP regulated industry, preferably contract sterilization. 
  3. Extensive working knowledge of cGMP, QMSR, ISO 13485 and ISO 14971 requirements. 
  4. Certified Quality Engineer (CQE) credential or equivalent qualification required. 
  5. High level of professionalism with excellent interpersonal and customer service skills. 
  6. Exceptional time management abilities with proven success managing multiple priorities simultaneously. 
  7. Outstanding verbal and written communication skills. 
  8. Demonstrated ability to take ownership and drive tasks to completion. 
  9. Demonstrated ability to work independently, collaborate effectively in a team, and drive projects to completion. 
  10. Ability to work in a fast-paced environment with the flexibility to adjust to and adapt to shifting priorities. 
  11. Strong analytical and problem-solving skills with sound decision making capabilities. 
  12. Dependable, punctual and committed to maintain a positive attitude and strong work ethic. 
  13. Must be authorized to work in the United States.

 

ESSENTIAL FUNCTIONS/PHYSICAL REQUIREMENTS

  1. Must be able to lift and move up to 40lbs.
  2. Frequently required to stand, walk, sit, use hands to handle and feel, use arms to reach, climb, balance, stoop, kneel, crouch, crawl, talk and hear.
  3. Full range of motion for wrist, hand and finger dexterity
  4. Distance vision/peripheral vision, depth perception, and ability to adjust focus.
  5. Must be able to operate a computer and other office machinery such as a copy machine and printer.

 

EOE/AA/M/F/Veteran/Disability

Related keywords

QMSMedical DevicePharmaCombination DeviceSterilizationECOSOPFDAQMSRCFR 210CFR 211ISO 13485ISO 14971cGMPCQECertified Quality Engineer

About Allentown, LLC

LinkedInVisit site

Your Trusted Partner in Biomedical Research Solutions

Industry
Research
Company size
201-500 employees
Founded
1968
Headquarters
Allentown, New Jersey
LinkedIn followers
4,160

Allentown is a global leader in biomedical research solutions, providing innovative equipment, integrated systems, and specialized services that support the evolving needs of modern life science facilities. For 58 years, leading research institutions, pharmaceutical organizations, and laboratory professionals across North America and around the world have trusted Allentown to help support critical research environments through advanced housing, workflow automation, sterilization, decontamination, environmental monitoring, and digital vivarium technologies. Our comprehensive approach combines precision-engineered equipment with responsive partnership and expert services — including professional decontamination and OneCall™ on-demand service solutions — helping facilities support operational continuity, research integrity, animal welfare, and long-term performance. From intelligent IVC platforms and automation systems to validation-grade decontamination solutions and connected vivarium technologies, Allentown delivers integrated solutions designed to support the full research environment. Behind every solution is a commitment to integrity, personal service, and care for the researchers, animals, and critical work taking place inside today’s laboratories. Driven by innovation, integrity, and care, we remain committed to advancing environments where life-saving research can thrive.

Offices: 165 Route 526, Allentown, New Jersey 08501, US

View all jobs at Allentown, LLC

About Allentown, LLC

LinkedInVisit site

Your Trusted Partner in Biomedical Research Solutions

Industry
Research
Company size
201-500 employees
Founded
1968
Headquarters
Allentown, New Jersey
LinkedIn followers
4,160

Allentown is a global leader in biomedical research solutions, providing innovative equipment, integrated systems, and specialized services that support the evolving needs of modern life science facilities. For 58 years, leading research institutions, pharmaceutical organizations, and laboratory professionals across North America and around the world have trusted Allentown to help support critical research environments through advanced housing, workflow automation, sterilization, decontamination, environmental monitoring, and digital vivarium technologies. Our comprehensive approach combines precision-engineered equipment with responsive partnership and expert services — including professional decontamination and OneCall™ on-demand service solutions — helping facilities support operational continuity, research integrity, animal welfare, and long-term performance. From intelligent IVC platforms and automation systems to validation-grade decontamination solutions and connected vivarium technologies, Allentown delivers integrated solutions designed to support the full research environment. Behind every solution is a commitment to integrity, personal service, and care for the researchers, animals, and critical work taking place inside today’s laboratories. Driven by innovation, integrity, and care, we remain committed to advancing environments where life-saving research can thrive.

Offices: 165 Route 526, Allentown, New Jersey 08501, US

View all jobs at Allentown, LLC

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