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. 3d ago
Looking for a job?
Let Zippia find it for you.
Clinical QA Auditor
Cs&S Staffing Solutions
Quality assurance specialist job in Princeton, NJ
Please, review and apply for this position through the QCI system following the link below (Copy and Paste): http://jobs.qcitech.com/jobseeker/Clinical_QA_Auditor_J02148106.aspx *You can apply through Indeed using mobile devices with this link.
Additional Information
$72k-120k yearly est. 10h ago
Specialist I, Quality Assurance
SGS 4.8
Quality assurance specialist job in Fairfield, NJ
SGS is the global leader and innovator in inspection, verification, testing and certification services. Founded in 1878, SGS is recognized as the global benchmark in quality and integrity. With over 97,000 employees in 130 countries and operating a network of more than 2,400 offices and laboratories, we provide services to almost every industry by assuring quality and safety of products and services.
Trusted all over the world, SGS is a market leader because we put 100% passion, pride and innovation into everything we do. We encourage new ideas. We welcome people who challenge the way we do things. And we will be 100% committed to helping you reach your full potential.
Specialist I, Quality Assurance is responsible for assisting management with the maintenance of the Quality Systems at SGS. Assignments are generally provided by a Team Leader or Manager. The Quality AssuranceSpecialist must be sensitive to the demanding regulatory compliance requirements attending to the operation of a pharmaceutical testing laboratory. This job also requires the ability to demonstrate a high commitment to interpersonal relations.
Provides support to technical staff in their efforts to ensure that routine testing submitted by clients is completed within established parameters governing turnaround time, quality specifications, etc.
Performs routine testing in conjunction with client-specific projects
Approves and issues Certificate of Analysis and signs on cGMP related reports
Participates in departmental and/or company-wide projects designed to improve the nature of SGS client services
Demonstrates willingness and ability to train on applicable general SOPs pertaining to the Analytical Laboratory
Participates in general staff training sessions as these are scheduled
Participates in departmental efforts directed toward equipment maintenance and calibration
Adheres to relevant SGS SOPs governing official records and documentation.
Compliance with applicable SOPs related to the handling of customer complaints
Qualifications
B.S. in Chemistry, Biology, Microbiology, or equivalent experience required
0-2 years of experience preferably in Life Sciences supporting cGMP Operations
Thorough knowledge of scientific principles is required
Additional Information
SGS is an Equal Opportunity Employer, and as such we recruit, hire, train, and promote persons in all job classifications without regard to race, color, religion, sex, national origin, disability, age, marital status, sexual orientation, gender identity or expression, genetics, status as a protected veteran, or any other characteristics protected by law.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with or without reasonable accommodations. The requirements listed above are representative of the knowledge, skills, and/or abilities required.
This job description should not be construed as an exhaustive statement of duties, responsibilities or requirements, but a general description of the job. Nothing contained herein restricts the company's rights to assign or reassign duties and responsibilities to this job at any time.
If you are applying for a position within the United States and you have difficulty completing the on-line employment application because of a disability, please call ************ for assistance and leave a message. You will receive a call back. Please note, this phone number is not for general employment information, but is only for individuals who are experiencing difficulty applying for a position due to a disability.
$75k-110k yearly est. 31d ago
Quality Assurance Compliance Specialist
Lancesoft 4.5
Quality assurance specialist job in Rockaway, NJ
Lead Quality Assurance resource needed to provide quality support for global computer validation projects in the ERP area, such as SAP, under the guidance of the Global Quality Computer Compliance team. Job duties will include: Reviewing and providing input to validation and test strategies
Verify documentation is in compliance with internal procedures and external regulations
Participate in review and approval of requirements, test scripts, reports and other SDLC documentation with a focus on quality, and testability
In addition, the resource may be pulled to support other programs of the following as needed:
Participate in process changes in the organization
Participate in audits
Participate in change management of additional systems
Education/Training/Work Experience:
The position requires a Bachelor's Degree in Engineering or Sciences with a minimum of 5-8 years experience working in life sciences industry with focus in the area of Quality Assurance.
Experience working with various GxP Enterprise Computerized Systems (on-premise and Cloud based (SaaS) COTS) used in the life sciences industry. Candidate must be well-versed with Software Development Life Cycle (SDLC) methodologies such as Waterfall and V-model. In-depth knowledge of US FDA regulations, ISO standards, MHRA and EU regulations (including Annex 11), and ICH guidelines and Drug Development Life Cycle process. Extensive experience developing and using risk based approaches for computer systems validation. Experience in managing multiple projects and determined to get job done correctly and on time.
Specialized Knowledge and Skills:
Knowledge in SAP is a plus. In addition, Microsoft Office experience (Word, Excel, PowerPoint). Experience with Microsoft SharePoint is also recommended. Good organization skills and strong interpersonal skills as well as ability to work with other departments.
Additional Information
All your information will be kept confidential according to EEO guidelines.
Quality assurance specialist job in East Brunswick, NJ
Job Description
Come work for a great company at APluscare!
The Quality assurance Coordinator is responsible for preserving the standard of the services of the agency. Quality assurance personnel are accountable for assisting to create and execute quality control and management methods and systems. Personnel are accountable for monitoring that the services of the agency meet the standard and are error free.
Job Duties:
The principal responsibility of quality assurance personnel is to make sure quality of the services provided by APluscare is at the highest level. Quality assurance employees must review the business statistics and then determine areas requiring enhancement. A quality assurance employee should also inspect the samples and formulate policies concerning improvement of the present quality standards. Personnel should ensure that the services take place in accordance with the standards established. Additional responsibilities include all other duties as assigned by APluscare.
The Quality Assurance Coordinator is required to:
Oversee and ensure agency's compliance with DDD regulations at all levels of operations.
Demonstrate broad knowledge of New Jersey Division of Developmental Disabilities (DDD) and Department of Human Services (DHS) licensing standards, regulations, and circulars.
Maintain agency's residential/other programs compliance with DDD, DHS, Medicaid, and other applicable state and federal regulations.
Cooperate and coordinate with state and other relevant officials during investigations of incidents that involve APluscare and/or its personnel.
Ensure agency's compliance with applicable federal and state laws, regulations, and licensing requirements.
Ensure agency's compliance with applicable accrediting bodies.
Suggest and participate in policy and procedure development, modification, renewal, as well as adherence while maintaining compliance with applicable requirements.
Provide weekly training and In-service to all staff involved in providing services and supports to clients of APluscare.
Conduct weekly visits and audits of all DDD licensed programs in order to maintain continuous compliance with DDD licensing standards.
Identify program deficiencies for all residential programs on a weekly basis and supervise program staff as needed to correct deficiencies.
Maintain DDD licensure renewal for all agency programs that are licensed by the division.
Maintains all company vehicles including registration, insurance, preventative maintenance, repairs, and equipment inventory according to APluscare policies and licensing standards.
Maintains all licenses/certificates for each APluscare program and prepares homes on a regular basis and for licensing inspections.
Prepare new programs for initial DDD licensing inspection and secure licensure.
Maintain continuous program integrity for all agency programs through quality assurance surveys and reviews.
Track and report on quality-related indicators, including areas of risk management and compliance.
Conduct weekly quality assurance surveys for all DDD licensed programs
Maintain agency compliance with all local, state, and federal regulations for all agency programs
Conduct monthly visits and audits of all residential and other programs
Prepare and submit program integrity and quality assurance weekly report to the Executive Director Identify program deficiencies for all residential and other programs on a monthly basis and supervise program staff as needed to correct deficiencies
All other duties as assigned by APluscare
Qualifications:
The Quality Assurance Coordinator is expected to posse s excellent interpersonal skills, including the ability to communicate effectively with in individuals with intellectual and developmental disabilities and their families, colleagues, and other parties as necessary for employment with APluscare. Outstanding negotiation skills, customer-oriented approach, excellent analytical skills, effective leadership capability to lead projects, fundamental knowledge of operational software and understanding concerning concepts, equipment and various other quality management techniques.
Employee must cooperate with the officer of licensing and/or any department of Human Service staff in any inspection or investigation
Employee must successfully complete and demonstrate proficiency in all areas of required training.
Valid Driver's License
Must be at least 18 years of age
Physical Demands/Working Conditions:
Handles detailed, basic to complex, and specialized concepts and problems, balancing multiple tasks simultaneously.
The ability to effectively communicate (orally and written) and interact with others, including diverse, interdisciplinary, cross-functional teams
The ability to read, concentrate and learn
Physical requirements include sitting, standing, walking, and computer work for long periods of time
Pushing, pulling, and lifting up to 50lbs
Driving and travel locally and between agency sites and other required locations
Support and maintain all corporate policies, procedures, and quality and confidentiality standards
Duties and responsibilities may be added, deleted or changed to meet the needs of the organization
$51k-76k yearly est. 17d 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 26, 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 2d ago
Quality Assurance Associate
RK Pharma
Quality assurance specialist job in East Windsor, NJ
Full-time Description
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.
Salary Description 18+
$50k-73k yearly est. 10d 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. 13d ago
Associate, In-Process QA Probiotics
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.
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.
First shift$24.00 to $30.50Second Shift$24.00 to $31.00
3rd shift 11.00 PM to 7:30 PM
$50k-73k yearly est. 23d ago
QA Auditor I - Temp role
Avet Pharmaceutical
Quality assurance specialist job in East Brunswick, NJ
This is a Temp onsite position based at our East Brunswick, NJ facility. The hours are 8:00 am - 4:30 pm, Mon-Fri with the occasional Sat. if needed.
• Determine whether quality activities and related QC-QA audits and processes comply with the cGMP requirement.
• Review of all the raw data including chromatograms and certificate of analysis generated during various testing in Quality control lab such as Raw material testing, packaging material testing, in-process testing, stability testing, equipment cleaning samples testing, Process validation samples analytical method validation/verification testing, etc.
• Review of protocols, raw data, and Reports related to instrument calibration and qualification.
• Review of raw data and Reports related to working standard qualification.
• Review the audit trails and ensure proper integration on Empower software as a basis of soft version review prior to the release of any certificate of analysis.
• Release of all the data on the SAP system and performing user decisions were ever required (example raw material/packaging material).
• Review of Deviation and out of specification related raw data and respective reports
• Review of daily calibrations like an oven, balance, pH meter, etc.
• Issuance of quality documents like Protocols, certificate of analysis, Laboratory Notebooks etc to QC.
• Performing Sample log in for all samples that are received in QC for testing.
• Preserving all the quality document related to testing and submitting to QA department for Archival as a part of document control.
• Provide support for Operations, Regulatory affairs, R & D and Quality Control objectives.
• Review of data and report related to Analytical method validation as required.
Reporting Relationships
• This will be more of individual contributor and working in a team of QA auditors responsible for review of analytical data generated in QC department and releasing of the material and reporting to Manager of QA.
Essential Functions:
• The person will record the analytical package received from QC for auditing
• The person will review the raw data received including not limited to data package, lab notebook, protocol pages etc. from QC related to testing and calibration.
• He will review the data with respect to the standard operating procedure and quality control methods.
• He will suggest correction and will ensure that the corrections are made prior to release of the material.
• Once raw data is audited, he will review the accompanying COA and will sign off the COA, if required.
• He will evaluate the results (perform 2 to 5) in SAP and then will give UD as required.
• They will collect and store the raw data (folders and lab notebook) and will submit to QA for archival.
• In case if there is Lab event, deviation or out of specification, the role will review all data generated as a part of investigation.
• The person will review the investigation report to ensure that there are no transcription errors in They report and will sign-off the report.
• The person will perform periodic audit trial review and will generate the report.
• The person will assist the department will upgrading / creating new SOPs as required.
• The person will assist the department by providing the requested data / document and by participation in any type of audit (internal and/or external).
Adhere to all safety and cGMP standards and guidelines, and report unsafe conditions, near misses, and/or injuries in a timely manner
Specialized Skills and Knowledge:
• A bachelor's degree with chemistry/pharmacy as major is required.
• Knowledge of handling HPLC and Empower chromatographic Software and minimum 3 years of experience in auditing of QC documents
• Knowledge of other QC testing.
• Knowledge of current cGMP Guidelines as needed for effective function of role.
• Reviewing and Auditing Skills.
• Basic knowledge of working on computers.
• Knowledge of various pharmacopeia
Key Competencies:
1. Effective Communication (Written and Verbal).
2. Analytical and Problem solving ability.
3. Document / Report drafting.
Physical Demands/Factors:
Work is primarily sedentary in nature; routine bending, walking, lifting and reaching are required.
The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodation may be made to enable individuals with disabilities to perform essential functions.
Based on the highly regulated workplace at Avet, employees will be required to meet minimum English proficiency requirements.
All applicants must be legally authorized to work in the U.S. for any employer. We are unable to sponsor any applicants for a work visa or take over sponsorship of a work visa for any applicants, at this time.
Avet is proud to be an Equal Opportunity Employer.
This job description is not all-inclusive. It acts as a guideline and is subject to change. Additional duties may be assigned based on business needs.
Compensation
Compensation:
This is a non-exempt position that pays $27 - 32 per hour.
$27-32 hourly Auto-Apply 11d 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. 10h 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. 35d ago
Aprio PH - Associate, Information Assurance Services (SOC)
Aprio 4.3
Quality assurance specialist job in Clark, NJ
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 Aprio's Information Assurance Services team and you will help clients maximize their opportunities. Aprio is a progressive, fast-growing firm looking for an IAS Associate to join their dynamic team.
Position Responsibilities:
* As an Associate in APRIO's IAS practice, a typical day might include:
Working with the engagement managers on clients across different industries Participating in client calls, conducting walk-throughs, interviews, etc. Developing test sheets, document request lists, and project plans Executing testing of clients' internal controls Drafting and formatting reports Testing of clients' internal controls Supporting clients' in problem identification and resolution Working with industry leading information security standards and frameworks, including ISO 27001, PCI DSS, NIST 800-53, NIST CSF, GDPR Reporting on clients' controls utilizing attestation standards such as SOC 1, SOC 2, PCI DSS, ISO 27001, GDPR and HITRUST Working on internal projects, i.e. process improvement, assisting with marketing and recruiting Information technology projects and focus areas you may be exposed to within the IAS practice as an Associate include the following: Cyber Threats and Cybersecurity Service Organization Control (SOC) Reporting (e.g., SOC 1 and SOC 2) Payment Card Industry Data Security Standard (PCI DSS) ISO Standards (e.g., ISO 27001/27002) HITRUST Agreed Upon Procedures GDPR, Privacy assessments
Qualifications Needed:
* Amenable to work Mid-shift (3:00 PM - 12:00 MN PHT)
* Work Set-up: Remote
* One or more industry relevant certifications or willingness to obtain relevant certification(s) within one year of employment. Certifications can include CPA, CISA, CRISC, CIPP, CISSP, CISM, QSA, or ISO/IEC 27001.
* Undergraduate Degree (required): preferably in Accounting/Finance/MIS/IS or related concentration - minimum 3.3 GPA
* Graduate Degree (desired): preferably in MIS, IS or Accounting Information Systems
* Strong communication skills; verbal and written, with the ability to produce excellent written reports and audit documentation.
* Ability and interest in continual learning and development.
* Commitment to exceptional client service and creative problem-solving ability with a consultancy mindset.
* Flexible, self-starter with the ability to interact with various levels of client and firm management.
* Ability to assist with performing audit and test procedures.
* Ability to manage personal schedule to coordinate multiple projects, tasks and deadlines.
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. 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
$45k-63k yearly Auto-Apply 47d ago
Asst OPS QA HACCP
Gategroup
Quality assurance specialist job in Newark, NJ
We're looking for motivated, engaged people to help make everyone's journeys better.
This position is responsible for the oversight of all HACCP logs in the Hot Foods Production ensuring that the logs are completed as per company policies and procedures. The position is also responsible for ensuring that all FDA processes are followed.
Annual Hiring Range:
$22.00 - $23.00
Benefits
Paid time off
401k, with company match
Company sponsored life insurance
Medical, dental, vision plans
Voluntary short-term/long-term disability insurance
Voluntary life, accident, and hospital plans
Employee Assistance Program
Commuter benefits
Employee Discounts
Free hot healthy meals for unit operations roles
Main Duties and Responsibilities:
Conducts temperature checks on products and ensures that all HAPPC, and FDA rules and regulations are followed along with managing the units log books.
Performs quality checks in the Hot Food kitchen to ensure that the specifications of the customer are followed
Ensures food produced in the Hot Foods is checked for temperature and placed in the refrigeration system per company policy
Checks temperature of food prior to moving the food into the refrigeration system
Randomly checks temperature of foods to verify that company policies are followed
Monitors personal hygiene
Supports customer audits and government audits to meet compliance
Monitors company policies and procedures and notifies management of issue if they arise
Responsible for safety, quality and compliance to customer specification
Monitors equipment for cleanliness and sanitation
Completes HACCP logs
Communicates product deviation to the unit production manager immediately
Ensures proper color code are applied to the product
Benefits
• Paid time off
• 401k, with company match
• Company sponsored life insurance
• Medical, dental, vision plans
• Voluntary short-term/long-term disability insurance
• Voluntary life, accident, and hospital plans
• Employee Assistance Program
• Commuter benefits
• Employee Discounts
• Free hot healthy meals for unit operations roles
Qualifications
Education:
High School graduate or equivalent with experience in related discipline required
Work Experience:
In-Flight catering experience is highly desired
Experience in a customer service environment is preferred
Technical Skills: (Certification, Licenses and Registration)
ServSafe training and certification required once hired
Language / Communication Skills:
Excellent oral and written communication skills
Job Dimensions
Geographic Responsibility: Unit
Type of Employment: Full time
Travel %: None
Exemption Classification: Non-exempt
Internal Relationships: Hot Food kitchen
External Relationships: N/A
Work Environment / Requirements of the Job:
Regularly, stands, bends, lifts, and moves intermittently during shifts of 10+ hours.
In a normal production kitchen facility there may be physical discomfort due to temperature and noise.
Must be able to lift, push, pull and move product, equipment, supplies, etc., in excess of twenty-five (25) pounds.
Detail oriented
Strong organizational skills, able to prioritize responsibilities and multi-task
Strong interpersonal skills, interact well with multiple departments as required
Able to work with little supervision
Organization Structure
Direct Line Manager (Title): QA/Manager/Production Manager
Dotted Line Manager (Title, if applicable): N/A
Number of Direct Reports: 0
Number of Dotted Line Reports: 0
Estimated Total Size of Team: 1
gategroup Competencies Required to be Successful in the Job:
Thinking - Information Search and analysis & problem resolution skills
Engaging - Understanding others, Team Leadership and Developing People
Inspiring - Influencing and building relationships, Motivating and Inspiring, Communicating effectively
Achieving - Delivering business results under pressure, Championing Performance Improvement and Customer Focus
Demonstrated Values to be Successful in the Position
Employees at gategroup are expected to live our Values of Excellence, Integrity, Passion and Accountability. To demonstrate these Values, we expect to observe the following from everyone:
We treat each other with respect and we act with
integrity
We communicate and keep each other informed
We put our heads together to problem solve and deliver
excellence
as a team
We have
passion
for our work and we pay attention to the little details
We foster an environment of
accountability
, take responsibility for our actions and learn from our mistakes
We do what we say we will do, when we say we are going to do it
We care about our coworkers, always taking an opportunity to make someone's day better
The above statements are intended to describe the general nature and level of work being performed by the individual(s) assigned to this position. They are not intended to be an exhaustive list of all duties, responsibilities, and skills required. Management reserves the right to modify, add, or remove duties and to assign other duties as necessary. In addition, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.
gategroup is an equal opportunity employer committed to workforce diversity. All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability status or other category under applicable law.
For further information regarding Equal Employment Opportunity, copy and paste the following URL into your web browser: ****************************************************************
We anticipate that this job will close on:
01/16/2026
For California Residents, please clic
k here to
view our California privacy notice.
If you want to be part of a team that helps make travel and culinary memories, join us!
$22-23 hourly Auto-Apply 14d ago
Quality Assurance Specialist
Community Hope 4.6
Quality assurance specialist job in Parsippany-Troy Hills, NJ
AT FIRST, FIVE DAYS PER WEEK IN-PERSON, IN-OFFICE. THEREAFTER, UPON COMPLETION OF ORIENTATION, ONE DAY PER WEEK ALLOWED REMOTELY.
A full-time, non-exempt position that coordinates quality improvement initiatives and ensures the integrity of the Agency's services. Responsible for monitoring the quality and delivery of support services to the organization's consumers and veterans.
Performance Management/Quality Assurance/Safety and Risk Management Activities
Prepares monthly/quarterly outcomes reports and shares metrics to key personnel.
Provides feedback on services in order to assist in improving and enhancing programs.
Coordinates and distributes satisfaction surveys.
Completes incident reviews and analyses; provides guidance and instruction to program leadership regarding unusual incidents, as needed.
Acts as a neutral point of contact for assigned programs, helping to resolve issues & address concerns.
Assist in licensing and accreditation activities as directed.
Provides technical support of the electronic health record to program staff.
Participates in the record review process and any relevant committees to ensure quality documentation that conforms to recordkeeping policies and regulations.
Grants & Contracts Activities
Monitor the data integrity of Electronic Healthcare Record (EHR) data.
Assists with development of new policies for new programs along with updating current policies.
Conducts compliance reviews of billing practices.
Conducts program site visits for monitoring compliance with organizational policies and regulatory requirements. Formulate recommendations on compliance processes as needed.
Assists and/or prepares required programmatic monthly, quarterly and annual reports for perspective and current funding sources.
Maintains knowledge of required regulating standards (i.e. Medicaid, State, County, CARF, etc.)
Qualifications:
Bachelor's degree in non-profit and/or human services administration/management with a minimum of two years quality assurance experience in a human services or related setting; Master's degree in related field preferred.
Must have knowledge of quality improvement process preferred.
Accuracy and attention to detail in the performance of duties is of critical importance;
Ability to deliver presentations and trainings to all levels of Agency personnel;
Proficiency in Microsoft Office and web-based applications; database and electronic healthcare record experience including HMIS strongly preferred.
VEVRAA Federal Contractor. Request Priority Protected Veteran Referral. EOE Minorities/Females/Protected Veterans/Disabled Contact.
Community Hope, Inc. is an EEO Employer - M/F/Disability/Protected Veteran Status View all jobs at this company
$33k-44k yearly est. 11d 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. 3d ago
Associate, In-Process QA Probiotics
Uspl Nutritionals LLC
Quality assurance specialist job in North Brunswick, NJ
Job Description
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.
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.
First shift
$24.00 to $30.50
Second Shift
$24.00 to $31.00
3rd shift 11.00 PM to 7:30 PM
$50k-73k yearly est. Auto-Apply 52d 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
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. 16d ago
Learn more about quality assurance specialist jobs
How much does a quality assurance specialist earn in Branchburg, NJ?
The average quality assurance specialist in Branchburg, 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 Branchburg, NJ