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GCP Quality Assurance Auditor
Suna Solutions
Quality assurance technician job in Paramus, NJ
Now Hiring: GCP Quality Assurance Auditor
Contract Length: 11 weeks
Pay Rate: $50-$60/hr (W2)
Schedule: Hybrid. Onsite Tuesday, Wednesday, and Thursday, each week. The hours can be flexible, between 7:30am and 5pm (8 hour shift).
About the Role
We are seeking a highly motivated GCP Quality Assurance Auditor to join our growing biopharmaceutical team focused on Neurology and Psychiatry therapies. Reporting to the Director of GCP/PVG Quality Assurance, you will play a key role in ensuring GXP compliance, implementing compliance initiatives, and supporting quality management systems across clinical operations, non-clinical, and manufacturing.
This position involves conducting both internal and external GXP audits, managing relationships with CROs, CMOs, investigator sites, and vendors, and supporting the organization in maintaining the highest quality standards. This is an onsite position in Northern New Jersey.
Key Responsibilities
Plan and conduct scheduled global clinical process and vendor audits across all clinical trials.
Conduct risk-based audits of specific clinical processes.
Perform clinical vendor audits alongside SMEs (e.g., IRT, EDC) to evaluate vendor services.
Prepare audit reports and distribute to relevant stakeholders.
Manage vendor non-conformances and follow up on corrective actions.
Review and apply clinical regulations and guidelines (FDA regulations, GCP, etc.).
Collaborate with clinical sourcing, supplier quality, and clinical teams to manage vendor performance.
Support regulatory inspections and participate in quality improvement projects.
Qualifications
Must have 2+ years of experience in radiopharmaceuticals and quality assurance.
Bachelor's degree in a scientific, healthcare, or related discipline.
Extensive knowledge of GCP and safety standards.
Experience conducting internal and external process and system audits.
Strong understanding of development policies, procedures, and SOPs/QMS.
Ability to work with global clinical teams to define audit objectives.
Willingness to travel up to 10%.
EQUAL EMPLOYMENT OPPORTUNITY STATEMENT:
Suna Solutions provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
Applicants, with criminal histories, are considered in a manner that is consistent with local, state, and federal laws.
REQUESTING AN ACCOMODATION
Suna Solutions is committed to providing equal employment opportunities for persons with disabilities or religious observances, including reasonable accommodation when needed. If you are hired by Suna Solutions and require accommodation to perform the essential functions of your role, you will be asked to participate in our reasonable accommodation process. Accommodations made to facilitate the recruiting process are not a guarantee of future or continued accommodations once hired.
If you would like to be considered for employment opportunities with Suna Solutions and have accommodation needs for a disability or religious observance, please call us at ****************, send us an email or speak with your recruiter.
PAY TRANSPARENCY POLICY STATEMENT
Compensation for roles at Suna Solutions varies depending on a wide array of factors including but not limited to the specific client, office or remote location, role, skill set and level of experience. As required by local law, Suna Solutions provides a reasonable pay scale to include the hourly or salary range that Suna Solutions reasonably expects to pay for roles that may be hired in California, Colorado, New York City or Washington.
$50-60 hourly 3d ago
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Manufacturing Technician
Fladger Associates
Quality assurance technician job in Ridgefield, CT
Responsibilities:
Excellent employment opportunity for a Pilot Plant Operator in the Ridgefield, CT area.
Follow the Lead of a Company Technician in pilot plant campaigns.
Work with plant technicians, campaign managers to address process and equipment related challenges.
Assist the company Lead technician in communication of the batch status with the chemist, Ch.D. analytical, MAS
Take all required training and complete before due date.
Be involved in-group activities such as the 9:00 AM and 2:00 AM meetings.
Become Proficient in Equipment operation, Batch record entries, calculations.
Attend PSOR Meetings, speak up and give input at these meetings.
Follow all procedures, including the wearing of and use of defined PPE.
Report all incidents, such as spills, exposures, cuts / abrasions etc. to management.
Conduct all operations and activities with Safety as the # 1 goal.
Experience:
High School Graduate or Associate Degree.
Experience working with established GMP procedures and bulk manufacturing.
Technical knowledge of manufacturing systems, methods and procedures.
Possess effective troubleshooting skills with equipment and/or process.
$33k-55k yearly est. 3d ago
Quality Inspector - 2nd Shift
LHH 4.3
Quality assurance technician job in Passaic, NJ
Our client, a well-established manufacturer serving regulated industries, is growing and seeking a Quality Inspector to join their 2nd shift. This position is ideal for someone who enjoys hands-on work and takes pride in maintaining high standards of quality.
Product Quality Inspector - 2nd Shift (3PM - 11PM)
Training: 1st Shift for the first 3-6 months
Responsibilities:
· Perform hands-on product testing and inspections to ensure compliance with specifications
· Accurately update and maintain product testing databases and quality documentation
· Record data in both manual and electronic files
· Communicate any non-conformance issues promptly to production teams and supervisors
· Assist with documentation control and manage retain samples and related records
Requirements:
· Previous hands-on experience in Quality Inspection or a similar role
· Strong attention to detail, organized, and results-oriented
· Ability to work independently and collaboratively
· Basic math skills and computer literacy required
· Must be able to train on 1st shift for 3-6 months then transitioning to 3rd shift
· Familiarity with ISO 9001 or other international quality standards is advantageous
Why You'll Love It Here: This family-owned company offers a union environment, a culture focused on employee development, and real opportunities for career growth. If you're detail-driven, adaptable, and ready to grow, this is the role for you!
Benefit offerings for full-time employment include 10 paid Holidays, and 10 PTO days, prorated based on hire date within the calendar year. Also included: Medical, dental, vision, term life and AD&D insurance, long-term disability, employee assistance program, onsite gym, and a 401k plan.
Equal Opportunity Employer/Veterans/Disabled
To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to *******************************************
The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:
• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance
We are seeking an experienced GCP Quality Assurance Auditor to join our rapidly growing biopharmaceutical company specializing in neurology and psychiatry therapies. This role ensures GXP compliance, drives quality management initiatives, and conducts internal and external audits across clinical trials, safety/pharmacovigilance, and vendor operations (CROs, CMOs, investigator sites).
The ideal candidate has extensive GCP experience, a strong pharmaceutical QA background, and expertise in radiopharmaceuticals. This is an on-site position in Northern NJ with flexible hours and minimal domestic travel.
Key Responsibilities:
Plan and perform global clinical process and vendor audits across all clinical trials
Conduct risk-based audits of clinical processes and vendors, including IRT and EDC systems
Prepare detailed audit reports and manage related non-conformances
Ensure compliance with GCP, FDA, EMA, and ICH regulations
Support regulatory inspections and quality improvement initiatives
Collaborate with clinical teams, QA, and vendor management
Qualifications:
Bachelor's degree in a scientific, healthcare, or related discipline
5+ years of pharmaceutical industry experience, including 2+ years in radiopharmaceutical QA
Extensive GCP and safety/pharmacovigilance experience
Proven experience in internal and external GXP audits
Familiarity with QMS, SOPs, clinical systems (IRT, EDC), and regulatory documentation
Strong communication and cross-functional collaboration skills
Up to 10% domestic travel
Why Join Us:
Be part of a fast-growing biopharma company making a difference in neurology and psychiatry
Hybrid work schedule with flexible hours
Opportunity for extension or full-time role
$68k-110k yearly est. 13d ago
Quality Control Technician
Corbion 4.1
Quality assurance technician job in Totowa, NJ
At Corbion, we exist to champion preservation in all its forms, preserving food and food production, health, and our planet. The Quality Control Technician is a 2nd shift position based at the Totowa, NJ plant reporting to the Quality Control Supervisor. This role is responsible for performing daily analytical tests, pre-operation and line audits, and ensuring production procedures and systems are followed. The position ensures that all quality standards are consistently met while supporting the development of QC team members.
Essential Functions
* Follow all GMP's (Good Manufacturing Practices), FSMA, Safety, and Environmental regulations as well as company policies.
* Maintain positive attitude. Focus on the customer, teamwork, and quality productivity.
* Give recommendations to improve workplace safety, efficiency, and to better serve the customer.
* Analyze finished product for various analytical testing including redox, Chittick, pH, %moisture, color, titratable acid (TA), enzymes, vitamins, proteins, etc., on a daily basis.
* Daily verification/calibration of lab equipment prior to testing finished product to ensure product quality.
* Maintain the cleanliness of the lab making sure that the areas are clean after testing.
* Ensure that lot codes and finished products package is correct and legible.
* Product that has been analyzed and does not meet specification, must be re-sampled and re-analyzed immediately. If product is not in compliance, HOLD stickers must be applied immediately and system hold activated.
* Participate in and successfully complete all required laboratory training classes.
* Complete the picking, testing and approval of raw materials, issuing deviation when the material is out of specification and reporting to the supervisor/manager.
* Keeping record of the materials that need to be tested for micro and send the samples on time.
* Duties, responsibilities and activities may change or new ones may be assigned at any time with or without notice.
Education & Experience
* Bachelor's Degree in Chemistry, Bio-Chemistry, Chemical Engineering, Biology or Microbiology.
* Experience in a laboratory environment within a related industry is required.
* SAP/Sample Manager experience preferred.
Knowledge, Skills and Abilities
* Strong analytical and problem-solving skills.
* Knowledge of laboratory testing procedures and equipment calibration.
* Ability to maintain compliance with GMPs, FSMA, HACCP, and company policies.
* Strong communication and teamwork skills.
Working Environment
* Manufacturing plant with large open floor areas and loud machinery.
* Exposure to high temperatures in summer and cold environments in winter.
* Dusty environment due to raw materials.
* Exposure to allergens including eggs, soy, sesame seeds, milk, and wheat.
Physical Demands
* Must wear GMP-compliant hair and beard nets, company-provided uniforms, gloves, and, in some areas, respirators.
* Ability to stand for long periods and perform repetitive laboratory or line auditing tasks.
* Must be able to lift up to 55 lbs.
Our offer
The below reflects the range of possible compensation for this role at the time of this posting. This range may be modified in the future. An employee's position within the salary range will be based on several factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, seniority, performance, location and business or organizational needs. The base salary range for this role is $24.00 to $25.00 per hour. In addition, we offer:
* Variable bonus potential
* Paid time off, including company holidays
* Medical, dental and vision coverage
* 401K with company match
* Education assistance
* Short- and long-term disability
* Employee Assistance Program (EAP)
About Corbion
Corbion is the global market leader in lactic acid and its derivatives, and a leading supplier of emulsifiers, functional enzyme blends, minerals, vitamins, and algae ingredients. We use our unique expertise in fermentation and other processes to deliver sustainable solutions for the preservation of food and food production, health, and our planet. For over 100 years, we have been uncompromising in our commitment to safety, quality, innovation and performance. Drawing on our deep application and product knowledge, we work side-by-side with customers to make our cutting-edge technologies work for them. Our solutions help differentiate products in markets such as food, home & personal care, animal nutrition, pharmaceuticals, medical devices, and bioplastics. In 2024, Corbion generated annual sales of €1,288.1 million and had a workforce of 2,399 FTE. Corbion is listed on Euronext Amsterdam. For more information: ***************
Corbion is an equal opportunity employer and committed to a diverse workplace. All applicants will be considered equally without regard to race, color, ethnicity, veteran status, religion, national origin, marital status, political affiliation, age, sex, sexual orientation, handicapping condition, membership in an organization or any other non-merit factors.
Corbion provides reasonable accommodation to applicants.
EOE/M/F/Vet/Disabled
Corbion does not accept unsolicited resumes from individual recruiters or third party recruiting agencies in response to job postings. No fee will be paid to third parties who submit unsolicited candidates directly to our hiring managers. All candidates must be submitted by approved Corbion vendors who have been expressly requested to make a submission by our Talent Acquisition team for a specific job opening. No placement fees will be paid to any firm unless such a request has been made by the Corbion Talent Acquisition team and such candidate was submitted to the Corbion Talent Acquisition Team.
Accountability Objectives:
Quality AssuranceTechnicians will ensure compliance of food safety and GMP systems along with quality programs, policies, procedures, and processes that are designed and necessary to ensure the production of safe quality food products.
Specific Accountabilities:
Inspect and Monitor daily Plant for Food Safety and Quality activities and any deviations report to Quality Supervisor.
Perform daily pre- operational sanitation inspection visual and swabbing before production starts.
Effectively communicate quality assurance expectations to production personnel.
Raw material inspection for specification compliance.
Conduct metal detector challenges and observations through the course of the shift.
Verify the calibration of all metal detectors, scales, and thermometers.
Conduct sensory evaluations of raw materials and finished product and record results.
Collect production samples for independent evaluation to ensure specification compliance for finished products.
Ensure compliance with established policies and procedures such as, HACCP, GMPs, SSOP, process deviation, hold and release.
Assist with solving problems by analyzing data, investigating issues, identifying solutions, and recommending actions.
Perform basic lab analysis (fat, Vacuum and Oxygen test) on in-process and finished products.
Enforce food safety and quality policies and procedures.
Perform Equipment calibrations (thermometer) and additional duties as directed.
Any issues related to FSQM are reported to quality management team.
Monitor incoming and outgoing product quality per company and customer specifications.
Qualifications:
Knowledge in food processing/HACCP/SQF, and/or regulatory compliance strongly preferred, but not mandatory. Fluent in English language, bi-lingual (Spanish) preferred. Ability to work a flexible schedule.
Preferred education: Associates Degree, Bachelors a plus
Ability to work independently. Basic knowledge of computer skills
In absence of QA technician, QA supervisor will back up for QA technician's role.
$20k-38k yearly est. Auto-Apply 14d ago
Production Technician
Green Thumb Industries 4.4
Quality assurance technician job in Warwick, NY
The Role
As a Production Tech, you'll be an essential part of the process of turning raw cannabis flower into our beautiful line of medicated products. Under the guidance of the management team, you will produce, package, and handle products, perform inventory duties, adhere to compliance requirements, and keep safety as your top priority while working daily in our facility. Here at GTI, we are looking for true team players who are the perfect hybrid between precision and energy.
Responsibilities
Deliver on production goals, while focused on safety and quality
Produce product per recipes and SOP's, maintaining high quality standards
Package product into proper containers with proper labeling to ensure compliance with state regulations
Ensure all standards for processing procedures and laboratory protocols are followed
Compliance with local and state regulations
Adherence to quality control methods throughout entire process
Documentation of manufacturing methods are created and maintained
Electronically convert packaged products in the state traceability system
Manage time efficiently to meet goals while consistently producing quality product
Practice good housekeeping habits throughout the facility with focus and personal contributions towards a clean and organized assigned work area at the end of the assigned shift
Exhibit competency in basic organizational skills, communication skills and Windows based operating software
Use independent judgment regarding product processing, keeping quality and goals in mind
Help create a positive environment by having a positive attitude and by being self-motivated
Other duties as assigned
Qualifications
High School Education or GED graduate; some college or college graduate preferred
1-2 years' experience in manufacturing, food processing, warehousing, and/or inventory preferred
Equivalent combinations of education and experience may be considered
Must be able to work well in a group and independently; demonstrate self-motivation and initiative
Must be able to adapt quickly to changes in policy, procedure, and technique
Employee must exhibit personal hygiene and follow the health guidelines set forth by GTI
Ability to listen well and communicate effectively with various audiences
Ability to perform monotonous tasks with great efficiency without losing qualities
Must be able to follow basic instructions and accept constructive criticism
Prior cannabis experience not required
Additional Requirements
Must have a valid driver's license or State ID card
Must be a minimum of 21 years of age
Must pass all required background checks
Must be and remain compliant with all legal and company regulations for working in the industry
Must be approved by the Cannabis Compliance Board to receive an Agent Card
Working Conditions
While performing the duties of this job, the employee is regularly required to perform reaching, grasping, bending, stooping, talking, hearing, seeing and repetitive motions.
Must be able to sit and/or stand for extended periods of time while maintaining focus.
PHYSICAL DEMANDS: Must be able to lift, carry, and balance up to 50 pounds AND must be able to do so with extreme care and caution when working with product.
Work involves daily exposure to allergens (such as cannabis, tree nuts, and coconut oil).
The pay range is competitive and based on experience, qualifications, and/or location of the role. Positions may be eligible for a discretionary annual incentive program driven by organization and individual performance.
Green Thumb Pay Range$19.50-$20 USD
$19.5-20 hourly Auto-Apply 46d ago
Quality Assurance Associate- Microbiology Testing
RK Pharma
Quality assurance technician job in Pearl River, NY
Full-time Description
RK Pharma Inc, a US based company with subsidiaries in India, is seeking multiple Quality Assurance Associates to complement our existing Quality Assurance team as we scale towards commercial manufacturing in the next upcoming months. As a company focused on the development, manufacturing and sale of high quality and affordable generic pharmaceutical products worldwide we are looking for sharp, driven, self-directed individuals to help us grow our mid-stage start-up team.
This position will report to our Quality Assurance Manager and focus heavily on reviewing documentation such as batch records, internal audits, microbiology testing, and ensuring cGMP compliance.
Requirements
If this sounds interesting to you, it's probably because up to this point you have:
A science degree, specifically in Microbiology.
Have worked in a CGMP regulated environment for at least 3 years or similar educational equivalency.
Have experience with wet chemistry, HPLC, GC, spectroscopy, or microbiology.
Thrived in an environment where growth and change are rapid.
Strong Quality Control background preferred.
The main responsibilities for this position are:
Review Quality Control documentation to ensure compliance with company procedures and cGMP and support issuance of CoAs and stability studies.
Revise quality and compliance standard operating procedures as required.
Review Quality Control method validation and method transfer protocols/reports.
Assist with Internal Audits.
Collaborate in management of deviations/CAPAs/change controls.
Assist in the supplier qualification of new vendors and periodical review of qualified vendors to maintain compliance.
Assist in the preparation and review of the Annual Product Review.
If this sounds like something that is of interest to you, please don't hesitate to apply to start a conversation.
We look forward to getting to know more about you and the skills you can bring to a company like RK Pharma Inc.
Salary Description 65,000 -75,000
$52k-76k yearly est. 12d ago
Quality Assurance Associate- Microbiology Testing
Careers at RK Pharma Inc.
Quality assurance technician job in Pearl River, NY
Job DescriptionDescription:
RK Pharma Inc, a US based company with subsidiaries in India, is seeking multiple Quality Assurance Associates to complement our existing Quality Assurance team as we scale towards commercial manufacturing in the next upcoming months. As a company focused on the development, manufacturing and sale of high quality and affordable generic pharmaceutical products worldwide we are looking for sharp, driven, self-directed individuals to help us grow our mid-stage start-up team.
This position will report to our Quality Assurance Manager and focus heavily on reviewing documentation such as batch records, internal audits, microbiology testing, and ensuring cGMP compliance.
Requirements:
If this sounds interesting to you, it's probably because up to this point you have:
A science degree, specifically in Microbiology.
Have worked in a CGMP regulated environment for at least 3 years or similar educational equivalency.
Have experience with wet chemistry, HPLC, GC, spectroscopy, or microbiology.
Thrived in an environment where growth and change are rapid.
Strong Quality Control background preferred.
The main responsibilities for this position are:
Review Quality Control documentation to ensure compliance with company procedures and cGMP and support issuance of CoAs and stability studies.
Revise quality and compliance standard operating procedures as required.
Review Quality Control method validation and method transfer protocols/reports.
Assist with Internal Audits.
Collaborate in management of deviations/CAPAs/change controls.
Assist in the supplier qualification of new vendors and periodical review of qualified vendors to maintain compliance.
Assist in the preparation and review of the Annual Product Review.
If this sounds like something that is of interest to you, please don't hesitate to apply to start a conversation.
We look forward to getting to know more about you and the skills you can bring to a company like RK Pharma Inc.
$52k-76k yearly est. 2d ago
Composite Manufacturing Technician
Liquidpiston Inc. 3.9
Quality assurance technician job in Bloomfield, NJ
About LiquidPiston LiquidPiston is transforming aerospace propulsion with its breakthrough rotary engine technology. As we expand into fixed-wing UAV and aircraft applications, we're building a world-class manufacturing team to deliver advanced aerospace components with precision and performance in mind. Join us in pioneering the future of flight.
Position Overview
We are seeking a Composite Manufacturing Specialist/Technician to lead the hands-on fabrication of carbon fiber, Kevlar, and epoxy components for fixed-wing UAVs and aircraft. The ideal candidate will be highly skilled in composite layup and mold-making, with an eye for craftsmanship and a passion for high-performance materials. This role involves working closely with engineers to develop a dedicated composite manufacturing space, processes, and prototypes-turning ideas into flight-ready parts.
Key Responsibilities
* Fabricate high-quality composite components (e.g., wings, fairings, and other structural elements) using carbon fiber, Kevlar, and epoxy systems
* Design and build molds for composite layups, including plug construction, tool prep, and vacuum bagging
* Comfortable with hand lay-up, vacuum bagging, Resin Transfer Molding (RTM), autoclave modeling, and compression molding techniques.
* Collaborate with engineering staff to develop manufacturing workflows, workspaces, and specialized tools
* Perform field repairs, composite part modifications, and rapid design iterations
* Ensure a clean, safe, and organized shop environment with a focus on consistent, top-tier fabrication quality
* Maintain documentation for fabrication processes, material usage, and design changes
Qualifications
* Proven hands-on experience in composite fabrication-ideally from aerospace, marine, motor sports, or performance product sectors
* Strong portfolio showcasing past projects and physical components (photos required)
* Skilled in mold-making, layup, vacuum bagging, and finishing techniques
* High attention to detail with a commitment to producing both mechanically sound aesthetically pleasing parts
* Self-driven, reliable, and focused on quality and committed to deadlines
* Excellent organization, cleanliness, and shop discipline are essential
Preferred Skills
* Experience with FEA (Finite Element Analysis) and structural optimization of composite components
* Comfort with CNC machining, hand tools, and general shop equipment
* Familiarity with small aircraft or UAV structures and aerodynamic design principles
Benefits & Perks
* Flexible PTO: We value work-life balance and encourage time to rest and recharge.
* Health & Wellness: Comprehensive medical, dental, and vision coverage-you choose what works best for you.
* Equity Participation: Permanent employees receive RSUs (Restricted Stock Units).
* 401(k) Match: We offer a 401k w/100% matching up to 3% of your salary and then 50% of contributions between 3-5%
* Career Growth: Ongoing training, mentorship, and learning opportunities to accelerate your growth.
Our Culture
At LiquidPiston, we embrace challenges, move fast, and celebrate curiosity. Our team thrives on collaboration, creativity, and perseverance. We understand that innovation involves risk-and we're not afraid to fail as we move forward.
Equal Opportunity Employer
LiquidPiston, Inc. is proud to be an Equal Opportunity Employer. Qualified applicants will not be discriminated against, and receive consideration for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, or protected veteran status or disability.
All offers of employment at LiquidPiston are contingent upon successful completion of a pre-employment background check and drug screening.
$32k-51k yearly est. 60d+ ago
Quality Assurance Associate II
Minaris
Quality assurance technician job in Allendale, NJ
The Quality Assurance Associate II (1st Shift, Tuesday-Saturday, 8:00 am- 4:30 pm) is responsible for performing Quality Assurance activities under direct supervision of daily tasks in support of Quality Systems and/or client procedures including but not limited to document management, review of QC data, material releases and final product releases as well as assisting Quality management with department needs.
Essential Functions and Responsibilities
Regular and reliable attendance on a full-time basis.
Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company's policies and practices.
Embodies Minaris Advanced Therapies values and aligns daily actions with department and company culture.
Ensures that all procedures and processes meet internal quality standards as well as external regulations specific to pre-clinical, clinical and commercial manufacturing.
Read, understand and follow all cGMP and cGTP documentation for Quality System Functions (SOPs,WIs,etc.)
Maintain cGMP and cGTP compliance for all aspects of pre-clinical, clinical and commercial manufacturing.
Release raw material in ERP system as well as on paper.
Perform Accessioning of incoming Apheresis.
Review Batch record and disposition material of finished product to client.
Provides information for Out of Specification and deviations to investigator.
Performs line clearance prior to manufacturing operations begins.
Other duties as assigned.
Knowledge, Skills & Ability
Relevant computer skills (Microsoft Office, Outlook)
Detail-oriented and organized
Analytical and problem-solving skills
Good written and oral communication skills
Ability to multi-task, prioritize, time manage and be adaptable
Flexible and able to adapt to company growth and evolving responsibilities
Ability to work independently and with a team
Education & Experience
BS or higher education degree in a scientifically related field
Experience in a biologics or biotechnology company (1 -3 years)
Working knowledge and technical understanding of the aseptic manufacture of biologics preferred
Working knowledge of GMP and TCTP regulations
Experience in reviewing GMP/GCTP related documents (validations/qualifications reports, SOPs, etc.)
Disclaimer
The above information in this description is intended to describe the general nature and level of work performed. It does not contain nor is it intended to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job. Duties, responsibilities, and activities may change at any time with or without notice.
$50k-73k yearly est. 8d ago
Quality Assurance Associate III
Lynkx Staffing LLC
Quality assurance technician job in Saddle Brook, NJ
Quality Assurance Associate IIIAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Quality Assurance Associate III is responsible for performing Quality Assurance activities within minimal supervision of daily tasks in support of Quality Systems and/or client procedures including but not limited to document management, issuance, review and approval of batch records, SOPs, Qualification and Validation Reports; review of QC data; perform material releases and final product releases; review of Deviations as well as assists Quality management with department needs. He/she exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. This role manages internal and external audits which may include interaction with Health Authorities and clients
Interfaces directly with client and cross functional teams
Provides resolutions pertaining to quality for project related issues
Independently prioritize, schedule, and manage multiple projects and resources (team)
Ensures the safe release of cellular products in accordance with company and/or client procedures and requirements.
Ensure and promote compliance with applicable CGMP and GTP regulations and company and client SOPs
Able to provide input based on knowledge and experience on quality systems and procedures and CGMP/GTP issues.
Author and review relevant SOPs, validation and other documents.
Responsible for the timely issuance, review and approval of QC certificates, closure of Batch Records, and deviation reports.
Responsible for the completion of all client requirements related to cellular product and/or material releases.
Master Batch Record Control, distribution and label verification
Perform line clearance activities as required.
Assignment and maintenance of product Lot numbers as applicable.
Perform internal documentation audits as assigned.
Materials management nonconformance disposition and release activity as applicable.
Responsible for accurate deviation reporting as applicable and tracking/trending follow up actions to closures
Evaluate and investigate deviation reports and initiate and coordinate corrective and preventive actions.
Track and trend relevant quality metrics including environmental monitoring data.
Provide Quality Assurance related support to various departments.
Interface with suppliers and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies.
Electronic Document Control activities as assigned.
Provide training to personnel as assigned by supervisor.
Travel may be required.
REQUIREMENTS
BS in biological sciences or other relevant field of study
5 years + experience in QA in a life sciences company company with a strong focus in the manufacturing and/or testing of biologics.
Working knowledge and technical understanding of aseptic manufacture of biologics
Understanding of quality system applications
Experience in both clinical and commercial manufacturing is preferred.
Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (validation/qualification reports, SOPS. Etc.
Experience in organizing teams for effective and timely completion of projects.
Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc.
Experience participating in or hosting health authority inspections and/or client audits.
Computer skills (Microsoft Office, Outlook)
Detail-oriented and organized
Analytical and problem-solving skills
Good written and oral communication skills
Ability to multi-task and be adaptable
Flexible and able to adapt to company growth and evolving responsibilities
Ability to work independently and with a team
Strong Project Management and organization skills
Must have the ability to work in a team-oriented environment and with clients
Must be able to work during the weekend, holidays and as required by the company
May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, etc. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
$50k-73k yearly est. 14d ago
Quality Control Technician
Fabrication Enterprises Inc.
Quality assurance technician job in Elmsford, NY
Job DescriptionQuality Control Technician About the Role
We import and source a diverse portfolio of physical therapy, occupational therapy, and sports medicine products from trusted manufacturers worldwide. We're looking for a hands-on Quality Control Technician who can be our “eyes and ears” on product quality and design. In this role, you'll work directly with suppliers to solve problems, prevent issues before they happen, and ensure our customers receive reliable, high-quality products.
You'll apply engineering troubleshooting and problem-solving methods to test products, diagnose failures, and work with manufacturers on improvements. This isn't a desk job-you'll be testing products, building simple test setups, measuring components, and diving into why something failed. You'll work across multiple product types and engineering disciplines, from electrical to mechanical to materials science.
What You'll Do
Test incoming product samples and production runs, checking that they meet specifications and function properly
Apply systematic engineering troubleshooting methods to diagnose product failures and defects
Communicate directly with factory partners about quality issues, test results, and improvement recommendations
Evaluate customer complaints and returns, determine root causes using engineering analysis, and recommend fixes
Proactively suggest design or manufacturing improvements to prevent problems
Document test results, failures, and findings in clearly written technical reports
Design and build simple test fixtures, jigs, or measurement setups as needed to evaluate products
What We're Looking For
Essential Qualifications:
2-5 years of hands-on experience in quality control, manufacturing, testing, product development, and technical troubleshooting
Solid understanding of engineering troubleshooting and problem-solving processes
Comfort using basic testing and measurement equipment: force gauges, load cells, calipers, micrometers, durability testers, electrical testers, or similar tools
Ability to systematically analyze problems-breaking down issues, forming hypotheses, testing solutions, and documenting findings
Clear written and verbal communication skills for reporting findings and coordinating with suppliers and colleagues
Ability to work independently and manage multiple quality issues simultaneously
Genuine interest in preventing quality problems and improving product reliability
Basic Excel or data logging skills necessary
Nice to Have:
Engineering degree or technical diploma (any discipline)
Basic knowledge of quality standards (ISO, ASTM) or medical device regulations
Familiarity with CAD software or technical drawings
Experience in medical device, equipment manufacturing, or regulated industries
Why You'll Like This Job
Variety: You'll work across multiple disciplines and product types-electrical, mechanical, materials, ergonomics, and more
Direct impact: Your work directly improves product quality and keeps customers satisfied
Hands-on engineering: If you love applying engineering principles to solve real-world problems, this role is for you
Supplier partnerships: You'll develop working relationships with factory partners and see your recommendations implemented
Supportive team: You'll work alongside our QA documentation specialist and have clear ownership of the technical quality side
About Fabrication Enterprises Inc.
FEI is a leading global supplier of physical therapy, occupational therapy, and sports medicine equipment with over 9,000 SKUs distributed to nearly 100 countries. For 50 years, we've built our reputation on quality and reliability by carefully specifying products, partnering with trusted manufacturers, and maintaining rigorous quality standards.
How to Apply
Please submit your resume along with a brief note (a few sentences) about your quality control or troubleshooting experience. We'd love to hear about a time you solved a tough quality problem using engineering analysis or made a process improvement.
$36k-52k yearly est. 6d ago
Quality Systems Technician
Jimmys Gourmet Bakery LLC
Quality assurance technician job in Clifton, NJ
Job DescriptionDescription:
Join our growing team as a Quality Systems Technician. In this role, you'll help maintain our company's high standards of food safety and product quality. You'll play a key part in supporting our BRCGS certification and ensuring we're always audit-ready. This position works closely with Production, Sanitation, Maintenance, and Warehouse teams to ensure every product meets our commitment to safety and excellence.
Responsibilities
Support audit preparation and documentation for BRCGS and third-party audits
Organize, file, and maintain all Food Safety and Quality Systems records
Conduct daily production checks to verify product consistency (color, shape, size, packaging, etc.)
Monitor and verify Critical Control Points (CCPs) and Preventive Controls
Report any quality issues promptly to the Quality Systems Supervisor
Collaborate with cross-functional teams to ensure compliance with Good Manufacturing Practices (GMPs)
Assist with sanitation documentation and monitoring activities
Requirements:
Strong attention to detail and organizational skills
Proficiency with Microsoft Excel and Outlook
Excellent written and verbal communication skills
Ability to work independently and as part of a team
A self-starter with a sense of urgency and commitment to quality
Work Environment & Safety
Adhere to all company safety policies and procedures
Use proper protective equipment and follow safe work practices
Remain alert and report any unsafe conditions immediately
Our Commitment to You
At Jimmy's Gourmet Bakery, we believe our team's success starts with feeling valued and supported. That's why we offer:
Competitive pay and performance bonuses
401(k) with company match
Health, dental, and vision insurance
Company-paid life insurance and EAP support
Generous PTO and career growth opportunities
Join a team that values your contributions and well-being.
$33k-59k yearly est. 19d ago
Fleet Quality Technician
Coco
Quality assurance technician job in Hoboken, NJ
At Coco, we're revolutionizing last-mile delivery with autonomous robots, making deliveries faster, more efficient, and more sustainable. We're looking for a proactive and tech-savvy Office Manager to oversee our facility operations, ensuring our teams have the resources and environments needed to thrive.
About the Role
As a Fleet Quality Technician, you'll be the backbone of our robot operations, assembling, maintaining, and deploying delivery robots with precision while leading efforts to diagnose and resolve hardware, electrical, and IoT issues. You'll design repeatable solutions that scale, perform hands-on repairs and testing, and provide critical feedback that drives future hardware improvements. This role is fast-paced, technical, and highly dynamic-perfect for someone who thrives on problem-solving, takes pride in getting things right the first time.
What You'll Do
Serve as the technical lead during robot deployments, identifying and resolving mechanical, electrical, and software integration issues in real time
Own the root-cause analysis and resolution process for fleet quality issues that impact launch success or fleet uptime
Design and implement scalable SOPs, tools, and diagnostics for frontline teams to reduce downtime and improve serviceability
Collaborate with Engineering, Supply Chain, and Field Operations to close the loop between product issues and fixes
Provide structured feedback to Product & Engineering teams and help pilot new hardware, software, or process changes in the field
Build lightweight dashboards, diagnostic logs, and technical documentation that can be adopted across teams
About You
4-6+ years in hardware operations, fleet maintenance, or field engineering with a focus on mechanical and electrical systems
Deep experience troubleshooting mechanical, electrical, and IoT (connectivity/sensor/data) issues
Strong systems thinking mindset-you see the big picture and design processes to solve root causes, not just symptoms
Independent, self-motivated, and solution-oriented-you don't wait to be told what's broken
Excellent communicator with the ability to work fluidly across technical and non-technical stakeholders
Familiarity with SQL, JIRA, inventory systems (e.g., Oracle ERP), and basic data analysis to spot trends and validate fixes
Comfortable in fast-moving environments and field-based problem-solving scenarios
Bonus Points
Prior experience in robotics, micromobility, autonomous delivery, or connected fleet operations
History of developing technical SOPs, diagnostic workflows, or cross-team enablement tools
Experience working closely with Engineering and Product teams to iterate on hardware or firmware in production environments
$36k-57k yearly est. Auto-Apply 60d+ ago
Quality Technician 2
Triman Industries Inc.
Quality assurance technician job in Yonkers, NY
Job Description
BASIC FUNCTIONS
Mid-level position. Performs counterfeit lab testing and visual inspection of various commodities including, but not limited to, electromechanical and electrical devices, electronic components, aircraft parts and hardware. This individual has the responsibility and authority to carry out assigned tasks.
SPECIFIC DUTIES
Visual and dimensional inspection of all product, including corresponding documentation received into CTG facility
Prepare and complete all necessary documentation (records) for reporting acceptance/rejection of items inspected and/or tested.
Ability to complete a full analysis on all EEE Devices within the Laboratory
Ability to operate all test equipment within the Laboratory Department
Identify nonconformity to provide data to Quality Manager.
Ability to communicate, document and report all nonconformity within internal system and direct supervisor.
Ability to conduct work as assigned by senior management.
Ensure daily tasks and priority inspections are completed ensuring all stock sales are completed for the day.
Ability to understand industry traceability and documentation requirement as required for each industry
Ability to evaluate and differentiate between various commodity types.
Review and implement detailed inspection reports to provide all information regarding product testing and inspection
Compile, review data and complete test reports IAW CTG Standards
Ability to use general inspection gages, Ex. Calipers, Micrometers, etc.
Ability to understand and decipher basic blueprint, data sheet, technical sheet requirements.
Must possess the ability to verify products fit, form and function by utilizing the appropriate gages to identify conformity.
Ensure First Article Inspection requirements are done in accordance with AS9102 and customer requirements.
For source conducted first article inspection, utilized tools, equipment as appropriate to conduct GD&T for inspection reports.
Complete AS9102 or equivalent or customer source designated reports for all First Articles and Source Inspections.
Comply with all requirements of the AS9120, ISO 9001, ASA-100, and IDEA QMS 9090 Quality Management System and criteria of CCAP-101, AS6081, AC7402 and ANSI/ESD-S20.20
STANDARD REQUIREMENTS
Comply with all requirements of International Standard ISO9001 and ISO27001, NIST 800-171, CMMC - Cyber Security and Informational Data Security Requirements. Aerospace Management System Standards AS9100, AS9120, IDEA-QMS-9090, ASA-100 and supporting construct standards AS6081, IDEA-STD-1010, AC7402-CAAP, CCAP-101, FAA AC00-56, ANSI/ESD S20.20. All employees shall commit and comply with the requirements of AS5553 for Counterfeit Electrical, Electronic and Electromechanical (EEE) Parts - Avoidance, Detection, Mitigation and Disposition practices.
METRICS AND MEASURABLES
Daily throughput (inspections/Lab steps completed)
Quality Issue detections (Incoming NCM )
Outgoing Quality (customer Escapes)
IDEA Certification and knowledge implementation
Use of GD&T and FAI knowledge for timely FAIR completion
Issue communication
Daily 6S/ESD/FOD policies followed
Ability to find datasheets/drawings information on CTG Systems
Diversity of inspections (EC/EM/HA/Hardware/etc)
Achieving CQI certification
EDUCATION / EXPERIENCE / COMPENTENCY
High School Diploma or equivalent with a minimum of 2 years' experience performing in-process and final inspection preferably in a machining, automotive or aerospace business
Must be proficient in English, both written and verbal communication skills
Good arithmetic skills are required
Mechanical aptitude desired
Ability to correctly use and interpret basic measuring tools including weight gauge, micrometer, caliper scale (linear), gauge blocks, thread gauges, and comparative standards Basic proficiency of Microsoft Excel and Word
Independent; can work with limited supervision and direction
Must complete IDEA-ICE-3000 Certification within 6 months of hire.
Able to pass internal testing and training to meet internal requirements
ASQ CQI certified or must completed certification within 1 year of accepting position
Strong Electronics inspection knowledge preferred
Must demonstrate acceptable vision requirement.
$30k-46k yearly est. 6d ago
Quality Inspector
Raycap Inc. 4.1
Quality assurance technician job in Kearny, NJ
Raycap, Inc. is seeking a highly motivated Quality Inspector. In this role, the Quality Inspector inspects components, sub-assemblies, and finished products received and/or built internally. This position works with Quality Management to implement the proper sampling plans based on component specifications, inspection plans, or customer-supplied requirements and to provide guidance on required quality tools, methods, and data to ensure that the shipped product fulfills all customer specifications and quality requirements. This position monitors and maintains Raycap quality processes to assure continual 100% customer satisfaction.
Shift: Monday - Friday (11:00 p.m. - 7:30 a.m.) with overtime as required.
Primary Job Responsibilities
Collects quality data as required to derive quality objectives
Executes and maintains comprehensive quality product inspections
Serves as a manufacturing focal point for intelligent analysis of quality issues, determining true root causes, and implementation of permanent corrective and preventive actions
Follows and promotes the use of and implementation of internal quality standards and procedures
Reviews documentation for compliance with quality standards
Inspects First Articles, incoming components, raw materials, fabricated parts, and in-process assemblies and subassemblies, products per Inspection Plans and Specification Requirements
Conducts subassembly tests as required to ensure quality products
Uses measuring equipment such as calipers and gauges
Audits and monitors quality requirements in accordance with the company's quality assurance policies and customer specifications
Documents and reports inspection findings, results, and monitors corrective actions to the inspection findings
Regular adherence to performance of applicable procedures in the Quality Management Systems (QMS), Environmental Management (EMS), and Occupational Health & Safety standards (OHSAS); ensuring processes remain sustainable, suitable, and effective in relation to the position
Continuous assessment of opportunities for improvement and any needed changes to management systems
Qualifications
Hands-on quality and manufacturing experience in an ISO certified environment.
Proficient in MS Office, Access, Outlook, and Adobe programs
Experience with Document Control software
Familiarity with SAP, ISO-9001, knowledge and application of DFx, FMEA, or similar Quality Systems is a plus
Who We Are
Raycap, Inc. creates products that protect and support the world's most valuable assets. We support advanced solutions for telecommunications, renewable energy, transportation, defense, and other applications worldwide.
We offer
A competitive benefit package
Paid Time Off from day one
10 annual company-paid holidays
A Tuition Reimbursement program
A generous 401(k) employer contribution
Raycap is an Equal Opportunity / Affirmative Action Employer. All qualified applicants receive consideration for employment without regard to age, disability, race, color, national origin, sex, marital status, sexual orientation, gender identity, religion, creed, veteran or military status, or other protected status. We participate in E-verify for all employment verifications. Drug-free workplace.
$30k-39k yearly est. Auto-Apply 33d ago
QC Technician
Actalent
Quality assurance technician job in Paterson, NJ
Main responsibilities are line auditing for production of bread, environmental monitoring and air sampling, as well as a being involved in a monthly SQF audit Calibration and Verification of scales, monitors, and other basic instrumentation Utilizing MS Excel, Word, and Office for basic documentation practices Monitor and verify product quality throughout the manufacturing process following GMP Perform visual inspections, monitor product weights, codes, labeling, and other quality checks to ensure product quality Address all Food Safety issues and customer complaints with the help of QA Supervisors Other periodic tasks week to week
Skills
Quality control, Communication, adaptability to change, HS Diploma, Food safety, microsoft, bilingual, gmp environment, Environmental Monitoring, HACCP, SQF, Production, Air Sampling
Top Skills Details
Quality control,Communication,adaptability to change,HS Diploma,Food safety,microsoft
Additional Skills & Qualifications
Nice to be HACCP or SQF Certified
Experience Level
Entry Level
Pay and Benefits
The pay range for this position is $25.00 - $27.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
* Medical, dental & vision
* Critical Illness, Accident, and Hospital
* 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
* Life Insurance (Voluntary Life & AD&D for the employee and dependents)
* Short and long-term disability
* Health Spending Account (HSA)
* Transportation benefits
* Employee Assistance Program
* Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Paterson,NJ.
Application Deadline
This position is anticipated to close on May 9, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
$25-27 hourly 60d+ ago
Quality Control Technician (Entry Level)
Freshline Produce LLC
Quality assurance technician job in Mahwah, NJ
Job Description
: Freshline Produce LLC., a premium fresh fruit and vegetable processor based in Mahwah, NJ, is seeking a talented Quality AssuranceTechnician, for its 1st shift, to join its fast growing organization.
This is perfect opportunity for a candidate looking to begin their QA career in the food industry.
Responsibilities:
Incoming Raw Materials/ Inspection/ Inform QA Manager and Operations Manager if there are quality issues. Fill out Receiving Log
Identify, label, date, and make a daily inventory list of all WIP products in the coolers
Production Line Quality Checks including product quality, case quality, Tsunami checks, Metal detector check and room temperature checks
Practice and enforce GMP regulations - (Hand washing, no jewelry, no gum)
Recognize and examine all inventory at all times
Serve as member HACCP Team
Requirements:
Good communication, training and interpersonal skills
Very detail oriented
Strong problem solving skills
Bi-lingual (English and Spanish) is preferred
Experience in the food industry is a plus
Effective organizational skill; Able to manage priorities and complexities
Intermediate computer skills
Proficiency with Microsoft Word, Excel and Outlook
Strong multi-tasking skills
$37k-53k yearly est. 28d ago
Incoming Materials Quality Control Technician
Cibo Vita Foods
Quality assurance technician job in Paterson, NJ
Job DescriptionWhat a Day Looks Like
In our Totowa, NJ facility, you start at the receiving dock-measuring, checking, and verifying that every pallet and part meets specification before it ever reaches production. You compare incoming materials to standards, note anything out of tolerance, and partner with suppliers to resolve issues quickly. Your careful records and clear communication keep our lines running smoothly and our quality uncompromised.
What You'll Tackle
Verify the quality of inbound materials against established specifications and acceptance criteria.
Document and escalate any defects, discrepancies, or nonconformances discovered during inspection.
Work directly with suppliers to address quality concerns and drive compliance.
Perform routine audits of receiving workflows to uphold high-quality standards.
Help develop and roll out quality assurance procedures and protocols.
Maintain precise inspection logs, checklists, and quality assessment records.
Contribute ideas and insights in team meetings to support continuous improvement.
What You Bring
High school diploma or equivalent; additional training in QA or a related field is a plus.
Experience in quality assurance or receiving is preferred.
Exceptional attention to detail and strong observational skills.
Comfort working independently and collaborating with a team.
Familiarity with quality control methods and tools.
Clear written and verbal communication skills.
Proficiency with basic computer applications and accurate data entry.
Location: Totowa, NJ
$37k-52k yearly est. 14d ago
Learn more about quality assurance technician jobs
How much does a quality assurance technician earn in Clarkstown, NY?
The average quality assurance technician in Clarkstown, NY earns between $22,000 and $70,000 annually. This compares to the national average quality assurance technician range of $26,000 to $60,000.
Average quality assurance technician salary in Clarkstown, NY