Quality assurance specialist jobs in Piscataway, NJ - 667 jobs
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Quality Assurance/Food Safety Manager
Carlo's Bakery 3.8
Quality assurance specialist job in Jersey City, NJ
PRIMARY RESPONSIBILITIES:
The Quality Assurance Food Safety Manager functions as a key member of the senior management team by being responsible for leading all aspects of quality, food safety, manufacturing regulations and overall sanitation within the SQF production facility. The QAFSM is responsible for developing, monitoring and maintaining Quality Assurance systems and programs to assure product integrity and compliance with SQF, GMP, HAACP, regulatory, customer standards and company Standard Operating Procedures (SOPs). They must also promote healthy, clean processing standards, documentation, training and employee development.
JOB REQUIREMENTS:
● 5+ years of Quality Assurance Management experience
● BA/BS Degree, Food Science, Food Technology, or a related field
● Education and experience in food-related technology, safety and management required
● Certification and training in SQF, HACCP, Food Safety required
● Experience working with regulatory agencies such as USDA, FDA, SQF and BV
● Excellent managerial, organizational, interpersonal skills, attention to detail, and ability to adapt to different needs and working styles of managers
● Must be a self-starter, able to work independently as well as part of a team to help achieve goals and maintain compliance
● Resourceful problem solver with ability to prioritize and tackle tasks each week
● Trustworthy and reliable with confidential communications
● Positive attitude and fortitude to work through an ever-changing, growing, and dynamic operation
● Proficient in Spanish preferred
PERFORMANCE RESPONSIBILITIES:
● Work closely with all departments to ensure the facility is always operating at the highest level of food safety standards. Ensure all staff follow and enforce rules, adhering to safety, food safety, and company SOPs.
● Closely support the Sanitation Manager in making sure proper cleaning and sanitation procedures are being followed
● Effectively manage the QA team, keeping all team members on task, and upholding a positive, food-safe culture
●Responsible for overseeing and managing the safe production of all products that meet company objectives. Monitor, report and fix deviations to standards
● Work in collaboration with the production management, operations and R&D teams to ensure standards are being met, and proper data is being collected
● Utilize food safety audit-readiness software to manage day-to-day operations and hold team members accountable
●Maintain supplier and internal documents as required by SQF - including, but not limited to, GFSI Certificates, COAs, COCs, raw material spec sheets, safety data sheets, product integrity logs, temperature tracking, trailer inspections, etc.
●Responsible for implementation and training of SQF rules, GMPs and compliance with regulatory standards
● Respond to and resolve customer quality complaints, conducting investigations and root cause analyses, implementing corrective and preventative actions where necessary
●Hold monthly senior management meetings to discuss complaints, non-conformances and implementation of solutions
● Create and maintain guides, conduct training for team members and visitors on GMPs, sanitation and food safety standards as required by SQF
● Work closely with R&D and production teams to document adherence to product specifications, production runs, results, timing, proper labeling, samples and trials
● Ensure the highest quality standards and good business relations are maintained with customers and governing agency representatives, such as USDA, FDA, and BV
● Verifies food safety and quality from supplier factories from raw material stage to finished product. Verifies texture, visual quality, shelf life, extended shelf life, temperature logs, packing alternatives along with R&D team
● Prepare regular reports and KPI's to establish accomplishments and efforts toward meeting objectives
● Oversee the launch of new products or trials, documenting production run data, customer and employee feedback
● Perform various lab tests to verify and validate food safety
● May participate in sensory and test panels, documenting the results
● May complete a variety of routine office tasks that may include typing, preparing reports, completing research, tracking information and KPI's, preparing or updating spreadsheets, copying, scanning, etc.
$90k-130k yearly est. 4d ago
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Quality Assurance Specialist
DSJ Global
Quality assurance specialist job in Jersey City, NJ
Quality AssuranceSpecialist - for Leading Food & Beverage Manufacturer
Jersey City, NJ Area
Quality AssuranceSpecialist
Are you a detail-driven, proactive professional passionate about food safety and quality excellence? Join a dynamic, fast-paced team at a leading food manufacturing facility where innovation, integrity, and continuous improvement are at the heart of everything we do.
We are seeking a Quality AssuranceSpecialist who thrives in a collaborative environment and is committed to upholding the highest standards of product quality, regulatory compliance, and operational efficiency.
Key Responsibilities:
Champion quality assurance initiatives across manufacturing and support facilities.
Lead and optimize quality control processes to ensure product safety and consistency.
Conduct inspections, audits, and testing aligned with FDA, USDA, and internal standards.
Drive compliance with food safety regulations including HACCP, SQF, and GMP protocols.
Analyze quality data, identify trends, and implement corrective/preventive actions.
Collaborate cross-functionally to enhance quality systems and continuous improvement efforts.
Develop and deliver training programs on QA procedures and food safety standards.
Manage vendor relationships and coordinate external support when needed.
Monitor regulatory changes and assess operational impact.
Qualifications & Skills:
Bachelor's Degree preferred (Food Science, Microbiology, or related field).
HACCP, SQF, or equivalent certification highly desirable.
2-5 years of hands-on experience in QA within the food and beverage sector.
Strong knowledge of FDA, USDA, and state/local regulatory frameworks.
Proficiency in Microsoft Office and QA software tools.
Exceptional analytical, organizational, and communication skills.
Bilingual in English and Spanish is a strong plus.
Quality assurance specialist job in Morris Plains, NJ
A technology company in Morris Plains, NJ is looking for a Mainframe QA Analyst to ensure the quality of mainframe systems. The role requires expertise in COBOL, JCL, DB2, and CICS, alongside 3-5 years of mainframe QA experience. Candidates should have strong analytical skills and experience with test management tools like JIRA. The position calls for both independent and collaborative work, emphasizing problem-solving and communication skills in a fast-paced environment.
#J-18808-Ljbffr
$70k-93k yearly est. 1d ago
QA Document Coordinator
Ivory Systems
Quality assurance specialist job in Hopewell, NJ
Job Title: QA Document Coordinator
Duties: Assist with adminstrative activities including but not limited to:
Proper labeling of all documents (2250+) documents in and entering document Archive Room
Logbook generation and issuance
Support shipping of documents offsite to Iron Mountain (secure GMP facility for documents) and ensure all documents are scanned prior to shipment
Other administrative duties as needed
Skills:
Exceptional organization and time management skills
Strong attention to detail with the ability to work accurately in a busy and demanding environment
Ability to successfuly work within strict timelines
Excellent work ethic
Education: Minimum Associates Degree
$51k-76k yearly est. 1d ago
Food Safety Quality Assurance Supervisor
Ajulia Executive Search
Quality assurance specialist job in New York, NY
Food and beverage industry
Certifications: SQF Practitioner Certificate, HACCP and PCQI
In-depth knowledge of FDA regulations, ISO 9001, ISO 13485, and HACCP principles.
Strong experience in QA/QC processes including conducting quality audits.
Are you looking to make a career change to a rapidly growing company? This exciting opportunity offers a competitive salary plus an excellent benefits package including medical insurance, dental insurance and paid PTO. Does this position match your future career goals? Then this opportunity could be the right fit for you
Very Competitive Benefits Package
Excellent Growth and advancement opportunities
Employment Type:
Full-time
Job Requirements and Duties:
Bachelor's degree in Science
5 plus years of food manufacturing industry experience
Certifications: SQF Practitioner Certificate, HACCP and PCQI
Preventive Controls Qualified Individual (PCQI) in accordance the Food Safety Modernization Act (FSMA) Preventive Controls for Human Food Rule
In-depth knowledge of FDA regulations, ISO 9001, ISO 13485, and HACCP principles.
Strong experience in QA/QC processes including conducting quality audits.
Manage the Food Fraud Program and Plant Security/Vulnerability Programs
Assist in New Customer Setups by verifying internal documentation matches customer specification requirements
Write, maintain, and improve quality system SOPs
Provide oversight and leadership of facility Quality Assurance team. Responsible for hiring and team member development
Manage the day to day operation of all quality function
Lead the team in the execution of HACCP plans and ensure proper documentation is maintained
Ensuring that manufacturing processes comply with standards at both National/ International level
Review SOPs & specifications
Oversee all aspects of daily quality operations
Manage budgeting
Ensure compliance with Federal, State and Local food safety regulations
Understanding of industry standards of Food Safety and Quality
Supports and participate to all the internal/external audits
Review test results
Provide, and oversee, inspection activity for product throughout production cycle
Apply total quality management tools and approaches to analytical and reporting processes
Schedule and coordinate preparations for product inspections and testing
Work to resolve noncompliance issues with materials or final product
Exceptional interpersonal skills and organizational skills
Benefits:
Great Pay
Very Competitive Benefits Package
Excellent work environment with growth opportunities
Immediate Hire
Jasleen Kaur
*********************************
Ajulia Executive Search is a search firm specializing in Manufacturing, Finance, IT, Legal and Pharmaceutical positions. This is a confidential search for one of our preferred clients. It is a direct hire position that includes competitive compensation and full comprehensive benefit package.
#ZR
$67k-105k yearly est. 1d ago
Quality Assurance Manager
Planet Pharma 4.1
Quality assurance specialist job in New York, NY
Experience Requirements:
Life Sciences Degree or related discipline
Minimum x (8) years of collective experience in quality management. 4 years in pharmaceuticals, or biotechnology.
Demonstrate knowledge of TGA, FDA, and EU GMP and other quality related systems (e.g., ISO Standards, ICH, PIC/s)
Job Purpose:
Accountable for providing QA Ops management of contractors to ensure compliance with quality and cGMP/cGTP standards, oversight of ongoing manufacturing campaigns and introduction of new product lines
$81k-116k yearly est. 3d ago
GIS QA/QC Analyst (Utilities)
Equiliem
Quality assurance specialist job in New York, NY
QA/QC Support Specialist
Brooklyn. NY
Hybrid
8am-4:30pm
PERFORMANCE DETAILS
What are the major objectives of the role?
The team is looking for another contractor as the electric eGIS team has undertaken a project to replace the legacy mapping systems with ArcFM, Schneiders mapping platform
Responsibilities/Job Description:
The candidate will be responsible to do multiple queries to validate the accuracy of legacy mapping data that was migrated to an Esri mapping system.
Candidate will review land base symmetry, connectivity at structures and assuring cable connectivity is intact.
Candidates responsibly is to check attribute data of all linear and point data features for Electric and Gas components
Candidate should perform map symbology updates and provide symbology solutions as is necessary.
Lead testing efforts for vendor deliverables, including factory acceptance, system acceptance, and user acceptance testing. Ensure that vendor-provided solutions meet the specified requirements.
Advocate for the customer throughout the testing process, ensuring that GIS solutions meet user expectations. Collaborate with development teams to address customer feedback and enhance system usability.
Conduct thorough reviews of project documentation related to test plan and execution. Offer insightful comments to enhance the quality of test plan documentation and provide approval. Review test plan and scripts to ensure alignment with project goals.
Utilize Azure DevOps or other testing software for effective test planning, execution, and reporting. Maintain testing documentation and artifacts in testing tools.
Demonstrate decisiveness in signing off on testing-related requirements and planning documentations ensuring alignment with project goals
Assist in other eGIS projects as the need arises
Develop understanding of Client eGIS project.
Develop a basic understanding of the Client mapping systems
Develop understanding of company mapping process, documents, and a wide variety of software programs
Develop ability to read various types of electrical and gas map
What are the MUST HAVE Professional or Technical skills for this position?
GIS Experience is a must have
Qualified candidates must have a Bachelor's degree. Must have at least (2) years' experience using ESRI ArcMap and demonstrate knowledge in Esri GIS is preferred
Candidate must be able to demonstrate knowledge in MXD building, spatial queries and spatial analysis
Candidate should hold experience within the utility environment
Candidates must be a self-starter, highly motivated with a high degree of attentiveness, integrity, energy, initiative and resourcefulness.
Candidate should be a quick learner and can carry out task to completion with minimum supervision
Must possess good analytical skills with a technical background, strong organizational skills and be able to use Microsoft office applications.
Education or Certification Requirement:
Bachelor's Degree
$65k-85k yearly est. 2d ago
QA Radiology Technician
NYC Health + Hospitals/Correctional Health Services 4.7
Quality assurance specialist job in New York, NY
NYC Health + Hospitals is the largest public health care system in the nation. We are a network of 11 hospitals, trauma centers, neighborhood health centers, nursing homes, post-acute care centers, and correctional health services. We are a home care agency and a health plan, MetroPlus. Our health system provides essential services to 1.4 million New Yorkers every year in more than 70 locations across the city's five boroughs. Our diverse workforce of more than 42,000 employees are uniquely focused on empowering New Yorkers.
NYC Health + Hospitals/Correctional Health Services is one of the nation's leading correctional health care systems in quality of and innovations to care, and access from pre-arraignment through compassionate release. In-jail services include medical, nursing, mental health, substance use treatment, social work, dental and vision care, discharge planning, and reentry support. In addition to providing direct patient care in the jails, CHS leverages the resources of the nation's largest municipal health care system to help discharged patients successfully return to their communities. CHS is also a pivotal partner in New York City's criminal justice reform efforts.
The Quality Assurance (QA) Radiological Technologist position encompasses responsible, administrative and clinical activity of varying degrees of latitude. Clinical level judgement is needed in the daily supervision of radiological functions and patient care, and departmental projects.
Responsibilities include:
Review exam orders, consult with radiologist, schedule patients and arrange for transportation as indicated.
Identify patient and document all information pertinent to final report in the RIS and on images (PACS).
Prepare all patients (infants, children, adolescents, adults and geriatric) for radiological procedures requested by the clinician. Arrange for proper protection of patients, public and staff from infectious diseases/materials.
Perform all general diagnostic imaging and routine examination in CT and Angiography.
Assists in performing daily checks of radiographic imaging equipment, immobilization devices and other necessary accessories.
Enters data and maintains documents and logs as required and mandated by the department QA guidelines and various regulatory agencies.
Maintains adequate stocks of supplies and materials needed for use in the department.
Checks equipment for defects prior for use and assures proper use of such equipment through instruction and review.
Report any unexpected patient incidents in accordance with the occurrence report protocol.
Maintain and exercise all mandated radiation safety regulations. Maintain basic care of all the imaging equipment. All malfunctions are to be reported to management staff whether mechanical, electrical or suspect and service request documentation completed. Maintain a clean and safe work environment for both patients and staff.
Perform other duties as deemed necessary (by supervisory or administrative staff) in the event of emergencies or disasters.
Continue professional growth and development of job-related skills on an ongoing basis. Participate in continuing education activities.
Ensure all examinations are accessioned, documented and sent to PACS for reading. Monitor PACS and RIS incomplete worklists to ensure all exams are completed.
In accordance with HIPAA (the Health Insurance Portability and Accountability Act), staff members will exercise due diligence in ensuring patient privacy and confidentiality.
Identifies activities that the network has implemented to promote patient safety and takes all necessary precautions to ensure a safe environment for patients, visitors and staff.
In addition to the Radiology Technologist job functions, the QA Technologists is responsible for the following:
Organize and file maintenance reports for each building in regards to dentistry and radiology x-ray equipment and ensure dentistry and x-ray equipment follow the Department of Health codes, policies and procedures.
Participates in quality assurance activities, including coordination, control and maintenance of technical equipment.
Establish a daily/weekly/monthly quality control routine for monitoring, evaluating, and maintenance of X-ray equipment to ensure optimal performance and stability.
Documenting and maintaining records for the quality control program in accordance with applicable regulations, legal requirements, accrediting agencies and recommendations from equipment manufacturers.
Performs research and participates in special projects involving evaluation of equipment and delivery of service.
Work with our radiologists to obtain updated documentation of primary diagnostic monitors.
Distribute/collect dosimeter badges from each employee/facility that works with x-ray equipment.
Recommends area assignment of personnel to coordinate activities within the department with other activities and services and represents the department in interdepartmental operations and meetings.
May be assigned duties and responsibilities of X-ray Director in regards to radiology department workflow.
Minimum Qualifications:
Assignment Level III
1. For Supervisory Assignments: a valid license and current registration to practice Diagnostic Radiography as a Radiologic Technologist issued by the NYSDOH; and two (2) years of Radiologic Technologist experience performing duties consistent with Assignment Levels I and II, one (1) year of which must have been in a supervisory capacity.
2. For Specialized Imaging Assignments: a valid license and current registration to practice Diagnostic Radiography as a Radiologic Technologist issued by the NYSDOH; and possession of a current advanced- level certification for the performance of these procedures.
NYC Health and Hospitals offers a competitive benefits package that includes:
Comprehensive Health Benefits for employees hired to work 20+ hrs. per week
Retirement Savings and Pension Plans
Paid Holidays and Vacation in accordance with employees' Collectively bargained contracts
Loan Forgiveness Programs for eligible employees
College tuition discounts and professional development opportunities
College Savings Program
Union Benefits for eligible titles
Multiple employee discounts programs
Commuter Benefits Programs
$36k-57k yearly est. 2d ago
Associate - ETS Project Quality Assurance
Con Edison, Inc. 4.9
Quality assurance specialist job in New York, NY
Are you ready to learn how technology projects are planned, funded, evaluated, and managed at a company that operates one of the largest energy delivery systems in the world? Con Edison's technology portfolio continues to expand in size, complexity, and strategic importance, structured Quality Assurance (QA) and effective project management practices have become essential. These technology projects directly support critical corporate priorities, including New York State's clean energy initiatives, improving customer experience, improving the reliability and resiliency of our grid and critical systems, and proactively managing cybersecurity and regulatory requirements.Under the supervision of the QA Manager within the Portfolio Governance and Risk team, the Tech Associate / QA Analyst will conduct quality assurance assessments of technology projects to ensure compliance with our Software Development Lifecycle (SDLC) methodology, project management standards, and corporate policies. Required Education/Experience
* Bachelor's Degree in Computer Science, Information Technology, Engineering, or related focus and a minimum of one year experience which includes cumulative work experience or equivalent internship/co-op experience, or six months of Con Edison co-op or internship experience or
* Master's Degree in Computer Science, Information Technology, Engineering, or related focus and a minimum of one year experience which includes cumulative work experience or equivalent internship/co-op experience, or six months of Con Edison co-op or internship experience.
Relevant Work Experience
* Ability to identify and articulate risks, gaps, and areas for improvement, required
* Demonstrated ability to quickly learn and apply standards, guidelines, and processes, required
* Collaborative, curious, and innovative mindset, required
* Experience with requirements gathering, documentation, Waterfall and Agile/Scrum methodologies, preferred
* Understanding of SDLC phases and project governance frameworks, preferred
* Familiarity with quality assurance frameworks such as PMI, CMMI, or ITIL, preferred
* Experience with automation tools such as Power Automate, scripting, or workflow automation, preferred
* Familiarity with AI tools and concepts, with interest in applying them to business processes, preferred
* Interest in Project Management, Quality Assurance, Governance, Automation, or Artificial Intelligence, preferred
* Experience with Power BI, Power Automate, or data visualization tools and SharePoint, Teams, or similar collaboration tools, preferred
* Interest in automation, scripting, or workflow optimization, preferred
Skills and Abilities
* Strong written and verbal communication skills
* Demonstrated problem solving skills
* Demonstrated analytical skills
* Possesses a high degree of initiative
* Well organized, detail oriented and flexible to handle multiple assignments
* Ability to work within tight timeframes and meet strict deadlines
Licenses and Certifications
* Driver's License Required
Physical Demands
* Sit or stand to use a keyboard, mouse, and computer for the duration of the workday
Additional Physical Demands
* The selected candidate will be assigned a System Emergency Assignment (i.e., an emergency response role) and will be expected to work non-business hours during emergencies, which may include nights, weekends, and holidays.
Core Responsibilities
* Maintain and update the technology project list to ensure accuracy and completeness
* Coordinate with project managers and stakeholders to validate project details, statuses, and milestones
* Conduct structured quality assurance reviews of technology projects to ensure compliance with standards and best practices
* Evaluate project documentation such as charters, requirements, designs, test plans, and deployment plans for accuracy and completeness
* Document findings, identify risks, and provide actionable recommendations for improvement
* Prepare and deliver monthly quality assurance reports and dashboards for senior leadership using tools like Excel and Power BI
* Identify trends and patterns across the portfolio to support proactive risk management and process improvements
* Contribute to the development and enhancement of automation, artificial intelligence tools, and other technologies that improve quality assurance processes
* Advocate for project management best practices and educate teams on standards and expectations
* Assist with special projects, testing, documentation, and maintenance of quality assurance tools as needed
$59k-73k yearly est. 5d ago
Associate, In-Process QA, MG/PG
USPL Nutritionals LLC
Quality assurance specialist job in North Brunswick, NJ
Date
06/2025
Title
Associate, In-Process Quality Assurance MFG/PKG
Department
Quality Assurance Operation Support
Reports to
Quality Assurance Manager/ VP of QA
FLSA (Exempt or Non-Exempt
Non-Exempt
Role Overview
The IPQA performs line inspection as part of the cGMP, SOPs, and policy compliance requirements as per CFR part 111. Performs In-process quality testing in manufacturing and/or packaging areas according to prescribed timelines and accurately captures test results in batch records. The Inspector performs calibrations & measurements on raw materials, bulk products, finished products and packaging components as required in batch records and SOP's. This position reports to the QA Manager and is a key member of the Quality Assurance group. The IPQA Associate is a highly organized self-starter who can work independently, demonstrates a positive attitude, and a bias for action.
Areas of Responsibility
IPQA - Level 1: To support In-process quality assurance activities by performing routine checks and verifications during manufacturing and/or packaging of nutraceutical products. This role ensures that all processes comply with applicable GMP, SOPs, and regulatory requirements.
Key Responsibilities:
???? Manufacturing Support
Perform line clearance before starting blending, granulation, compression, encapsulation, coating processes.
Perform In-process checks:
Blend uniformity sampling
Tablet/capsule weight variation
Hardness, friability, and disintegration tests etc as applicable
Verify equipment cleaning and area hygiene as per SOP.
Collect and label In-process and stability samples under supervision.
???? Packaging Support
Ensure line clearance before packaging activities.
Perform In-process checks:
Batch number and expiry date printing
Label application and carton sealing
Primary and secondary packaging integrity etc as applicable
Assist in reconciliation of packaging materials (e.g., printed cartons, leaflets, labels).
???? Documentation
Record observations in IPQA checklists, logbooks, and batch records.
Maintain GMP documentation in real-time (legible and error-free).
Escalate any deviation or abnormality immediately to the QA Executive/Supervisor.
???? Compliance & Safety
Adhere to company GMP, SOP, and Hygiene policies.
Use PPE appropriately.
Support during internal/external audits by providing necessary records.
Cleans up work following the completion of a shift.
Meets all safety expectations and follows all safety practices.
Works extended hours and occasional weekend overtime.
Other duties as assigned
Other Responsibilities Including Safety:
IPQA - Level 2: To independently perform and document In-process quality assurance activities at all critical stages of manufacturing and packaging of nutraceutical products, ensuring compliance with GMP, SOPs, and regulatory requirements.
Key Responsibilities:
???? Manufacturing Stage (Granulation, Blending, Compression, Encapsulation, Coating )
Carry out and document line clearance activities before starting each manufacturing batch.
Conduct in-process checks independently:
Blend uniformity sampling
Tablet/capsule weight variation
Hardness, friability, thickness, and disintegration
In-process controls as per BMR specifications
Verify equipment cleanliness status, calibration, and logbook entries.
Monitor and record environmental conditions in production areas (temperature, RH, differential pressure).
???? Packaging Stage
Conduct line clearance for primary and secondary packaging (bottles, strips, blister, cartons).
Perform and document:
Batch coding verification (batch no., Mfg/Exp date)
Packaging material correctness (labels, leaflets, cartons)
Sealing integrity checks (blisters, induction seals)
Online rejection bin and reconciliation checks
Ensure correct usage of approved packaging materials with status labels.
???? Documentation & Compliance
Fill Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) in real-time.
Record IPQA observations and results as per SOPs ( legible and error free).
Initiate and report deviations, OOS/OOT, and non-conformities to QA Supervisor/ Manager.
Support CAPA implementation and change controls.
???? General QA Duties
Ensure compliance with GMP, GLP, and data integrity principles.
Follow gowning protocols, hygiene, and safety measures in production areas.
Assist during internal audits and regulatory inspections by providing accurate documentation and data.
Cleans up work following the completion of a shift.
Meets all safety expectations and follows all safety practices.
Works extended hours and occasional weekend overtime.
Other duties as assigned
Other Responsibilities Including Safety:
IPQA - Level 3: To lead and monitor In-process QA activities during nutraceutical manufacturing and packaging operations. Ensure compliance with GMP, regulatory standards, and internal SOPs by supervising IPQA teams, reviewing records, and addressing quality deviations.
Key Responsibilities:
????IPQA Oversight - Manufacturing & Packaging
Supervise and verify line clearance activities across all manufacturing and packaging areas.
Ensure compliance with critical process parameters (CPPs) and critical quality attributes (CQAs).
Review and approval:
In-process checks: weight variation, hardness, friability, disintegration etc as applicable
Environmental monitoring records
Equipment and area cleaning records
Coordinate and monitor sampling activities for In-process, finished products and stability studies.
???? Review and Verification
Review and verify completed Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR).
Cross-check reconciliation of raw materials and printed packaging materials.
Verify proper use of status labels (approved/rejected/quarantine).
???? Deviation & CAPA Management
Investigate and document process deviations, non-conformances, and OOS/OOT incidents.
Lead root cause analysis (RCA) and implement Corrective and Preventive Actions (CAPA).
Coordinate with cross-functional teams (Production, QC, Regulatory Affairs) to ensure closure of quality events.
???? Audit & Compliance
Ensure readiness for internal, external, and regulatory audits (FSSAI, WHO-GMP, USFDA, etc.).
Conduct routine GMP audits, spot checks, and area inspections.
Train shop-floor personnel on data integrity, documentation practices, hygiene, and gowning protocols.
???? Team Coordination
Guide and mentor IPQA Level 1 and Level 2 personnel.
Allocate daily QA responsibilities and monitor adherence to QA procedures.
Conduct on-the-job training for new team members
Cleans up work following the completion of a shift.
Meets all safety expectations and follows all safety practices.
Works extended hours and occasional weekend overtime.
Other duties as assigned
Other Responsibilities Including Safety:
Meets all safety expectations and follows all safety practices.
Works extended hours and occasional weekend overtime.
Other duties as assigned
Other Responsibilities Including Safety:
N/A
Other Responsibilities Including Safety:
Works in a safe and responsible manner to create an injury-free and incident-free workplace.
Complies with all job-related safety and other training requirements.
Keeps management informed of area activities and of any significant problems.
Requirements
Education & Qualification:
IPQA - Level 1:
0-1 year (Freshers with training or internship in QA preferred)
Or equivalent combination of education and experience.
High School diploma is required; BS degree in a life science discipline (e.g., Chemistry, Microbiology, Biochemistry) a plus.
IPQA - Level 2:
Minimum of 3+ years of experience in a QA Inspector within a nutritional's supplements, food, consumer products or pharmaceutical company.
Or equivalent combination of education and experience.
BS degree in a life science discipline (e.g., Chemistry, Microbiology, Biochemistry) a plus.
IPQA - Level 3:
3-5 years in IPQA or related QA roles in nutraceuticals, pharmaceuticals, or food manufacturing. Or equivalent combination of education and experience.
BS degree in a life science discipline (e.g., Chemistry, Microbiology, Biochemistry) a plus.
Certifications, Licenses, Credentials:
N/A
Skills & Ability
IPQA - Level 1:
Basic understanding of GMP, nutraceutical processes, and QA principles.
Good observation and attention to detail.
Willingness to work in production areas (shifts, growing zones).
Ability to follow instructions and standard procedures accurately.
Basic proficiency in English and documentation practices.
IPQA - Level 2:
Strong knowledge of IPQA functions, SOPs, and process flow in nutraceuticals.
Understanding of basic analytical parameters (weight variation, friability, etc.).
Good documentation and observational skills.
Proficient in using basic lab and QA tools (weighing balances, disintegration testers).
Familiar with regulatory guidelines (FSSAI, WHO-GMP, USFDA, HACCP).
IPQA - Level 3:
In-depth understanding of nutraceutical manufacturing processes and regulatory compliance.
Proficient in QA documentation, process audits, and deviation handling.
Strong analytical and decision-making skills.
Familiar with QMS tools, GMP documentation, and data integrity principles.
Working knowledge of SOP writing, change control, and risk assessment.
Physical Requirements (lifting, etc.):
Ability to lift up to 35 lbs.; occasionally lift and move up to 50 pounds.
Must stand and walk on production floor a minimum of 6 hours per shift
Uses hands to finger, handle, feel, or operate objects or controls, lifting to waist height and/or above shoulder height, frequent bending from waist, or squatting, walking short distances.
Occasionally works from a rolling ladder or step stool.
Must be able to wear all PPE including lab coat, face mask, booties, gloves, safety glasses.
Work Environment (Office, Warehouse, temperature extremes, etc.):
Work is regularly performed inside a manufacturing and packaging environment where temperatures can be moderate, exposure to dust, odors, noise, and fumes. The noise level is usually moderate. Employees can be exposed daily to chemicals and cleaning agents.
The above statements are intended to describe the general nature and level of work being
performed by people assigned to this job. They are not intended to be an exhaustive list of all the job responsibilities, duties, skill, or working conditions. In addition, this document does not create an employment contract, implied or otherwise, other than an "at will" relationship.
USPL is proud to be an Equal Opportunity Employer.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity or expression, national origin, age, genetic information, disability, protected veteran status, or any other characteristic protected by applicable local, state, or federal law.
Benefits And Compensation: Our benefits are designed to help you move forward in your career, and in areas of your life outside of USPL. From health and wellness benefit options including: medical, dental, vision, short and long term disability, basic life insurance, supplemental life insurance, AD&D insurance. We also offer a matched 401(k) savings plan. Employees have the opportunity to receive compensation in the form of premium pay such as overtime, shift differential, holiday pay, sick time, etc. Newly hired employees receive up to 10 days of vacation the first year, which grows to 12 days starting the second year of employment.
shift schedule
3rd shift: 11:00 PM - 7:30 AM
3rd Shift - 11:00 PM to 7:30 AM
$50k-73k yearly est. 7d ago
QA Associate
Actalent
Quality assurance specialist job in East Windsor, NJ
Job Title: QA AssociateJob Description We are seeking a dedicated QA Associate to join our quality assurance team. In this role, you will be responsible for managing and coordinating various quality-related tasks, ensuring compliance with industry standards, and supporting continuous improvement initiatives within our organization.
Responsibilities
* Coordinate and participate in the investigation of quality deviations and non-conformances, including Deviation, LIR, OOS, and CAPA management.
* Assist in implementing Corrective and Preventive Actions (CAPAs) to address root causes and prevent recurrence.
* Coordinate change controls by working with the change initiator and evaluating associated risks.
* Prepare for and support both internal and external audits, including those conducted by regulatory agencies such as the FDA.
* Track and manage quality events within the company's electronic Quality Management System, including change controls, deviations, LIR's, OOS, and product complaints.
* Compile, report, and analyze quality metrics to identify trends, compliance risks, and improvement opportunities, presenting findings during biweekly or monthly quality reviews.
* Prepare annual product review (APR / APQR) reports.
* Participate in the management of the vendor and supplier qualification program.
* Communicate with suppliers and vendors for qualification and documents required for regulatory filing.
* Support continuous improvement and maintain overall site quality.
* Ensure adherence to GMP and good documentation practices.
* Comply with all company policies and procedures.
Essential Skills
* Associates Degree or Bachelors Degree in Chemistry.
* 1-2 years of Quality Assurance experience.
* Experience on the manufacturing floor, laboratory, wet chemistry, titration, and chromatography.
Additional Skills & Qualifications
* Technical knowledge in chemistry and wet chemistry.
* Proficiency in computer applications and programs related to laboratory applications.
* Understanding of mathematics, including statistics.
* Knowledge of sample preparation techniques.
* Familiarity with spectroscopic techniques and chromatographic systems.
* Basic computer knowledge, including MS Excel, Word, and Outlook.
Work Environment
The position operates within a laboratory setting, typically with a team of around 10 people. The facility is part of a growing CMO with a focus on high performance and cutting-edge developments in a new facility.
Job Type & Location
This is a Contract to Hire position based out of East Windsor, NJ.
Pay and Benefits
The pay range for this position is $30.00 - $35.00/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 East Windsor,NJ.
Application Deadline
This position is anticipated to close on Jan 22, 2026.
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.
$30-35 hourly 5d ago
QA Associate
Artech Information System 4.8
Quality assurance specialist job in Morris Plains, NJ
Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.
Job Description
1. The incumbent will have responsibility to ensure that all aspects of the operational business comply with cGMP legal and regulatory requirements, the Client Pharma Corporate Quality Manual and Policies, and site procedures and business requirements.
2. Coordinates and performs batch record issuance for internally manufactured products Reviews and approves manufacturing and QC related documents for raw material disposition.
3. Reviews and approves manufacturing and QC related documents for manufactured media Performs administrative functions for filing and maintenance of records between QA operations and Document Control Center Support cGMP and associated OJT training to QA and other departments to improve right the first time (RTFT), high quality performance.
4. Control costs within department to meet budget. Complete job-related training in electronic database system along with GMP, safety, and Ethics & Compliance course requirements.
5. Perform or support any other tasks necessary to maintain the product quality and site cGMP compliance, as needed. Skills:0-3 years GMP manufacturing and/or QA related experience
6. Education: BS/BA in Biological Sciences or equivalent relevant career experience
Additional Information
Regards,
Anuj Mehta
************
$53k-71k yearly est. 1d ago
Quality Assurance Associate
Careers at RK Pharma Inc.
Quality assurance specialist job in Hightstown, NJ
Job DescriptionDescription:
RK Pharma Inc, a vertically integrated pharmaceutical company headquartered in NJ, is seeking an Quality Assurance Associate to work with our growing 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
is located in
East
Windsor,
NJ
and is required to be
onsite.
Requirements:
If this sounds interesting to you, it's probably because up to this point you have:
Bachelor's degree in Pharmaceutical Sciences, Chemistry, Biology, or a related technical field.
1-3 years of experience in a pharmaceutical or GMP-regulated environment.
Solid understanding of cGMP, GDP, and FDA regulations.
Experience with batch record review, deviation handling, and change control processes.
Familiarity with document management systems (e.g., MasterControl).
Strong attention to detail and accuracy in reviewing technical and regulatory documents.
Excellent written and verbal communication skills for cross-functional collaboration.
Ability to work independently and manage multiple priorities in a fast-paced environment.
The main expectations and responsibilities for this position are:
Review batch production and packaging records for accuracy, completeness, and GMP compliance prior to product release.
Perform in-process line checks and quality inspections to ensure adherence to SOPs and specifications.
Support deviation and change control processes, ensuring timely investigation and documentation.
Participate in internal audits, walkthroughs, and inspection readiness activities.
Maintain and update controlled documents, including SOPs, MBRs, and validation protocols.
Collaborate with Quality Control, Production, and Engineering to resolve quality issues and drive continuous improvement.
Ensure all QA activities are properly documented in accordance with GDP and data integrity principles.
Support training, risk assessments, and compliance reviews as assigned by QA management.
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.
$50k-73k yearly est. 16d ago
PT Quality Assurance Associate
Ahold Delhaize
Quality assurance specialist job in Woodbridge, NJ
At Food Lion, Associates are the most important assets to our organization. We want associates to have meaningful careers full of variety and challenges. Each associate contributes to the overall success of Food Lion, and in return, we strive to provide all associates with a fulfilling work experience and reward performance and commitment. We are committed to the professional development of our associates through on-the-job learning opportunities and training.
At Food Lion, Associates are the most important assets to our organization. We want associates to have meaningful careers full of variety and challenges. Each associate contributes to the overall success of Food Lion, and in return, we strive to provide all associates with a fulfilling work experience and reward performance and commitment. We are committed to the professional development of our associates through on-the-job learning opportunities and training.
Food Lion provides equal employment opportunities to all associates and applicants for employment without regard to race, color, religion, sex (including pregnancy, childbirth and related conditions) national origin, age, disability, sexual orientation, veteran status, gender identity or gender expression or any other characteristic protected by law.
If you have a disability and require assistance in the application process, please contact our Recruiting Department at ***********************
$50k-73k yearly est. 60d+ ago
Quality Assurance Associate
Lupin Pharmaceuticals
Quality assurance specialist job in Somerset, NJ
Lupin U.S. is comprised of a fast growing, innovative and robust team of manufacturing, Research and Development and commercial divisions. Somerset, New Jersey is home to one of eighteen commercial manufacturing sites globally and the only commercial manufacturing facility in the United States for Lupin. Somerset, New Jersey is also the location for Lupin's U.S. Sales Operations and Marketing divisions, as well as internal Product Development teams. Lupin has a significant generic pipeline and a growing Specialty Brand presence in the U.S. Our Inhalation Research and Development facility is located in Coral Springs, Florida focusing on generic and branded orally inhaled and nasal drug products. Key shared service functions are found at our beautiful harbor side location in Baltimore, Maryland. Adding to Lupin's U.S. footprint is a robust team of Clinical Operations experts in Blue Bell, Pennsylvania and a high performing Specialty salesforce located across the country. Lupin is prided on being people-focused and centered around how impactful we are with our customers. Join our U.S. team and become part of an organization that encourages professional development and innovation! We are looking for passionate and driven individuals who will help us to continue making medicine widely accessible to patients, and who strive to work by Lupin's Core Values of Teamwork, Passion for Excellence, Entrepreneurial Spirit, Respect and Care, Integrity, and Customer Focus.
Responsibilities
Role Summary
The QA Associate is responsible for the assurance of the manufacturing activities within the Lupin Somerset sites. This position is responsible for working in the warehouse, process rooms, and packaging lines and evaluates all activities meets the acceptance criteria.
This position will require 2nd shift hours: 2:00 p.m. - 10:30 p.m. Monday - Friday
Essential Duties and Responsibilities
Sample, inspect incoming raw materials, components, in-process, intermediates, and finished products and submits samples to the QC laboratory for analysis.
Inspect the manufacturing equipment/rooms and packaging lines/ equipment for cleanliness and approve them for use before the start of the operation
Perform QA in-process checks (Beginning, Middle and End) for manufacturing/packaging operations and determine the results meets against pre-determined standards and batch record
Conduct AQL inspections on incoming materials and finished dosage forms against pre-determined Quality attributes.
Collect and maintain QA Retain samples from all products manufactured. Assure that all retains are stored appropriately for accountability, annual inspection
Sample and proofread all pharmaceutical labeling for conformance to the standard. Issues approved labels to the packaging lines for use.
Inform immediately any manufacturing/packaging issue to the QA supervisor
Assure all activities are following the batch records, departmental SOP's, GMP, and DEA regulations.
Review of online batch records in terms of completeness of signatures, entries, and actual reconciliation/yields.
Ensure the proper isolation of rejected or defective product/ material generated during the batch process and accountability in the batch record.
Monitor facility and product environmental operating conditions.
Provide necessary support to conduct root cause analysis for any incidents generated at the facility during all phases of the production and packaging process.
Perform other QA duties as assigned
Qualifications
Education & Experience
An Associate Degree or a Bachelor's Degree in a scientific field is preferred
Minimum 3+ years' experience in a Quality Assurance role in the pharmaceutical industry
Knowledge of the pharmaceutical manufacturing and/or packaging process
Communication skills: Excellent command of written and spoken English
Attention to detail is paramount
Desire to achieve a high quality of work and diligent about following
Standard Operating Procedures
Knowledge and understanding of cGMPs, keeping up to date with current industry issues and changing regulations.
SAP, Trackwise, LIMS or similar QMS system knowledge preferred
Lupin is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, gender, religion, age, disability, veteran status, or any other classification as required by applicable law.
The anticipated annual base salary range for this position in New Jersey is $45,000 to $63,000, plus a discretionary performance bonus (based upon eligibility). The final salary offered to a successful candidate may vary and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, the type and length of experience within the industry, skillset, education, business needs, etc. Lupin is a multi-state employer, and this salary range may not reflect positions that work in other states.
Physical Requirements
The physical requirements of the position generally include: standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking and hearing. In some circumstances, bending, kneeling, crouching, stooping, and crawling may apply. This position may require lifting up to 15 pounds occasionally. Generally, work is performed in a manufacturing environment.
Search Firm Representatives Please Read Carefully
Lupin USA, and its Affiliates does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms for any current openings at our company without a valid written search agreement in place will be deemed the sole property of Lupin. No fee will be paid in the event a candidate is hired by Lupin as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, No phone calls or emails.
#LI-CC
#LI-DNI
Work with a nationally ranked CPA and advisory firm that is passionate for what's next. Aprio has 30 U.S. office locations, one in the Philippines and more than 2,100 team members that speak 60+ languages across the globe. By bringing together proven expertise, deep understanding, and strategic foresight for fast-growing industries, Aprio ensures clients are prepared for wherever life or business may take them. Discover a top-rated culture, vast growth opportunities and your next big career move with Aprio.
Join our Assurance team and you will help support clients maximize their opportunities. Aprio has a career opportunity for an Associate, Assurance Services to join their dynamic group.
Position Responsibilities:
* Our team of credentialed audit experts work with businesses and industry leaders to avoid financial and business risk that can be distracting, costly, and debilitating if not mitigated. We work with companies to improve financial reporting capabilities, internal controls, evaluate accounting issues, and stay ahead of the curve with new accounting regulations that could have potential impact on long-term business growth. We help companies assess the quality of information they use to make strategic business decisions, and help identify areas where they can improve operating efficiencies.
* Skillfully and accurately performing audits
* Preparing audit work papers and adjusting trial balances
* Compiling financial statements into a written report to be presented
* Creating and strengthening relationships with coworkers and clients
* 4-year bachelor's degree in Accounting
* Master's degree preferred
* Licensed CPA or 150 credit hours to sit for the exam
* 0-1 year of experience working for an Accounting firm
* Understanding and applying Excel skills
* Demonstrating exceptional verbal and written communication skills are required
* Working effectively and personably with clients and co-workers
* Strong time management skills with the ability to prioritize tasks and meet deadlines
* Excellent critical thinking and analytical problem-solving abilities
Perks/Benefits we offer for full-time team members:
* Wellness program
* HMO coverage
* Rewards and Recognition program
* Free shuttle service (provided by CDC | for onsite employees)
* Free lunch meal (For onsite employees)
* On-demand learning classes
* Discretionary time off and Holidays
* Performance-based salary increase
* Discretionary incentive compensation based on client or individual performance
* Hybrid set up to selected roles/location, terms and conditions may apply
* CPA & Certification Assistance and Bonus Program
What's in it for you:
* Working with an industry leader: Be part of a high-growth firm that is passionate for what's next.
* A great team: Work with a high-energy, passionate, caring, and ambitious team of professionals in a collaborative culture.
* Growth opportunities: Grow professionally in an environment that fosters continuous learning and advancement.
* Competitive compensation: You will be rewarded with competitive compensation.
EQUAL OPPORTUNITY EMPLOYER
Aprio is an Equal Opportunity Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race; color; religion; national origin; sex; pregnancy; sexual orientation; gender identity and/or expression; age; disability; genetic information, citizenship status; military service obligations or any other category protected by applicable federal, state, or local law.
$59k-72k yearly est. 19d ago
Quality Assurance Associate
Proven 3.5
Quality assurance specialist job in Princeton, NJ
Proven is an interactive design and development consultancy that blends creative vision with technical expertise to craft digital experiences that matter. We partner with non-profits and mission-driven organizations, leveraging our design, engineering, and strategic capabilities to drive meaningful impact.
We're looking for a full-time Quality Assurance Associate to serve as the primary owner for quality assurance across our projects. In this role, you will design and execute test strategies and plans for web applications, working within an Agile framework and collaborating closely with project managers, developers, and clients. You will help ensure that every release meets both functional requirements and Proven's high quality standards.
Key Responsibilities
Lead and track all QA activities across assigned projects.
Create, execute, and maintain test plans and test cases based on user stories, acceptance criteria, and requirements.
Perform functional, system, integration, regression, and performance testing to ensure consistency and reliability across environments and systems.
Identify, prepare, and manage test data for manual and (when applicable) automated testing.
Collaborate with clients and internal teams to define, refine, and validate user acceptance criteria.
Validate all tickets resolved by the development team prior to release, ensuring they meet requirements and are production-ready.
Automate regression test scripts where appropriate and help evolve our automated testing coverage and standards.
Identify, document, and prioritize defects; track them through resolution.
Proactively surface risks, dependencies, and quality concerns to the project manager and team.
Contribute to improving QA processes, tools, and documentation over time.
Qualifications and Experience
You are hyper-organized, detail-oriented, and comfortable independently owning your work to ensure quality and client satisfaction.
3+ years of experience working in a QA or testing role at a technology company, digital agency, or similar environment.
Experience working as a tester on technical projects within an Agile software development lifecycle.
Hands-on experience with several of the following:
Functional and regression testing
System and integration testing
Performance, load, and speed testing
User acceptance testing (UAT)
Working knowledge of modern web development technology stacks (e.g., common front-end frameworks, APIs, CMS platforms) and how they impact testing.
Strong analytical and problem-solving skills; you can not only find bugs, but also help the team understand impact and potential root causes.
Excellent written and verbal communication skills; you're comfortable collaborating with cross-functional teams and interacting with senior stakeholders.
Experience working remotely with distributed teams.
Bachelor's degree in engineering, computer science, or a related field, or equivalent relevant experience.
Why Join Proven?
Mission-Driven Work: Help organizations that make a real impact in the world.
Collaborative Culture: Work alongside talented designers, strategists, and engineers.
Growth Opportunities: Shape the future of Proven's technology team and strategy.
Remote Flexibility: Work from anywhere while leading a distributed team.
$52k-75k yearly est. 38d ago
Quality Assurance Associate III
Lynkx Staffing LLC
Quality assurance specialist 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. 15d ago
Mainframe QA Analyst
Highbrow LLC 3.8
Quality assurance specialist job in Morris Plains, NJ
Job Title: Mainframe QA Analyst
Job Travel Location(s):
# Positions: 3
Employment Type: W2
Duration:Long Term
# of Layers:0
Work Eligibility:All Work Authorizations are Permitted - No Visa Transfers
Key Technology:COBOL, JCL, DB2, CICS
Job Responsibilities:
Ensure the quality and functionality of mainframe systems and applications, primarily working on COBOL, JCL, CICS and DB2.
Design and execute test cases, analyze requirements, troubleshoot issues and improve performance.
Develop detailed test cases and test data based on requirements, conduct manual testing focusing on functional, integration, regression and system testing.
Execute test cases on mainframe environments and validate data accuracy in DB2.
Log, track the defects and perform Root cause analysis of the defect.
Collaborate with cross functional team
Prepare and present the test results and metrics.
Skills and Experience Required: Required:
3 -5 years of experience in Mainframe QA activities
Knowledge of COBOL, JCL, DB2, CICS
Experience in working with large data sets, data validation and SQL queries
Familiarity with mainframe testing tools - automation testing
Knowledge of test management tools - JIRA
Work experience with Agile methodologies and scrum framework
Good analytical skills and attitude to learn newskills
Problem solving and troubleshooting skills
Strong communication and Interpersonal skills
Ability to work independently and as a team.
Education:
Bachelor's degree in related field or equivalent work experience.
#J-18808-Ljbffr
$70k-93k yearly est. 1d ago
QA Associate
Artech Information System 4.8
Quality assurance specialist job in Morris Plains, NJ
Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.
Job Description
The incumbent will have responsibility to ensure that all aspects of the operational business comply with cGMP legal and regulatory requirements, the Client Pharma Corporate Quality Manual and Policies, and site procedures and business requirements.
Coordinates and performs batch record issuance for internally manufactured products Reviews and approves manufacturing and QC related documents for raw material disposition.
Reviews and approves manufacturing and QC related documents for manufactured media Performs administrative functions for filing and maintenance of records between QA operations and Document Control Center Support cGMP and associated OJT training to QA and other departments to improve right the first time (RTFT), high quality performance.
Control costs within department to meet budget.
Complete job-related training in electronic database system along with GMP, safety, and Ethics & Compliance course requirements.
Perform or support any other tasks necessary to maintain the product quality and site cGMP compliance, as needed.
Skills:0-3 years GMP manufacturing and/or QA related experience
Education: BS/BA in Biological Sciences or equivalent relevant career experience
Qualifications
Skills:
0-3 years GMP manufacturing and/or QA related experience
Education: BS/BA in Biological Sciences or equivalent relevant career experience
Additional Information
Sneha Shrivastava
Technical Recruiter (Clinical/Scientific)
Artech Information Systems LLC
360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960
Office: ************ | Fax: ************
Connect with us on - LinkedIn | Facebook | Twitter
$53k-71k yearly est. 1d ago
Learn more about quality assurance specialist jobs
How much does a quality assurance specialist earn in Piscataway, NJ?
The average quality assurance specialist in Piscataway, NJ earns between $53,000 and $122,000 annually. This compares to the national average quality assurance specialist range of $41,000 to $97,000.
Average quality assurance specialist salary in Piscataway, NJ
$81,000
What are the biggest employers of Quality Assurance Specialists in Piscataway, NJ?
The biggest employers of Quality Assurance Specialists in Piscataway, NJ are: