Quality assurance specialist jobs in Morristown, NJ - 319 jobs
All
Quality Assurance Specialist
Quality Assurance Associate
Quality Assurance Auditor
Quality Assurance Coordinator
Quality Assurance Internship
Quality Assurance Analyst
Quality Specialist
Quality Assurance Lead
Quality Assurance Assistant
GCP Quality Assurance Auditor
Suna Solutions
Quality assurance specialist job in Paramus, NJ
Now Hiring: GCP Quality Assurance Auditor
Contract Length: 11 weeks
Pay Rate: $50-$60/hr (W2)
Schedule: Hybrid. Onsite Tuesday, Wednesday, and Thursday, each week. The hours can be flexible, between 7:30am and 5pm (8 hour shift).
About the Role
We are seeking a highly motivated GCP Quality Assurance Auditor to join our growing biopharmaceutical team focused on Neurology and Psychiatry therapies. Reporting to the Director of GCP/PVG Quality Assurance, you will play a key role in ensuring GXP compliance, implementing compliance initiatives, and supporting quality management systems across clinical operations, non-clinical, and manufacturing.
This position involves conducting both internal and external GXP audits, managing relationships with CROs, CMOs, investigator sites, and vendors, and supporting the organization in maintaining the highest quality standards. This is an onsite position in Northern New Jersey.
Key Responsibilities
Plan and conduct scheduled global clinical process and vendor audits across all clinical trials.
Conduct risk-based audits of specific clinical processes.
Perform clinical vendor audits alongside SMEs (e.g., IRT, EDC) to evaluate vendor services.
Prepare audit reports and distribute to relevant stakeholders.
Manage vendor non-conformances and follow up on corrective actions.
Review and apply clinical regulations and guidelines (FDA regulations, GCP, etc.).
Collaborate with clinical sourcing, supplier quality, and clinical teams to manage vendor performance.
Support regulatory inspections and participate in quality improvement projects.
Qualifications
Must have 2+ years of experience in radiopharmaceuticals and quality assurance.
Bachelor's degree in a scientific, healthcare, or related discipline.
Extensive knowledge of GCP and safety standards.
Experience conducting internal and external process and system audits.
Strong understanding of development policies, procedures, and SOPs/QMS.
Ability to work with global clinical teams to define audit objectives.
Willingness to travel up to 10%.
EQUAL EMPLOYMENT OPPORTUNITY STATEMENT:
Suna Solutions provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
Applicants, with criminal histories, are considered in a manner that is consistent with local, state, and federal laws.
REQUESTING AN ACCOMODATION
Suna Solutions is committed to providing equal employment opportunities for persons with disabilities or religious observances, including reasonable accommodation when needed. If you are hired by Suna Solutions and require accommodation to perform the essential functions of your role, you will be asked to participate in our reasonable accommodation process. Accommodations made to facilitate the recruiting process are not a guarantee of future or continued accommodations once hired.
If you would like to be considered for employment opportunities with Suna Solutions and have accommodation needs for a disability or religious observance, please call us at ****************, send us an email or speak with your recruiter.
PAY TRANSPARENCY POLICY STATEMENT
Compensation for roles at Suna Solutions varies depending on a wide array of factors including but not limited to the specific client, office or remote location, role, skill set and level of experience. As required by local law, Suna Solutions provides a reasonable pay scale to include the hourly or salary range that Suna Solutions reasonably expects to pay for roles that may be hired in California, Colorado, New York City or Washington.
$50-60 hourly 4d ago
Looking for a job?
Let Zippia find it for you.
Quality Assurance: Product Inspector Internship
Wakefern Food Corp 4.5
Quality assurance specialist job in Elizabeth, NJ
Program Dates
May 19th, 2026 - August 7th, 2026
About Wakefern
Wakefern Food Corp. is the largest retailer-owned cooperative in the United States and supports its co-operative members' retail operations, trading under the ShopRite , Price Rite , The Fresh Grocer , Dearborn Markets , Fairway Markets , Gourmet Garage , and Morton Williams banners.
Employing an innovative approach to wholesale business services, Wakefern focuses on helping the independent retailer compete in a big business world. Providing the tools entrepreneurs need to stay a step ahead of the competition, Wakefern's co-operative members benefit from the company's extensive portfolio of services, including innovative technology, private label development, and best in class procurement practices.
Your contribution
If you are a student who is pursuing an education in Supply Chain Management, Food Engineering, Quality Assurance, Quality Control Management, or other related fields, these internship opportunities may be a great fit for you! Wakefern prides itself in being the industry leader in Logistics and Distribution. Our organization currently services over 400+ retail stores throughout the northeast. The Logistics Infrastructure includes 9 warehouses in New Jersey and Pennsylvania, housing 4 million square feet of warehouse space. Wakefern's fleet of over 2000 trailers ship approximately 1.4 million cases daily while traveling 52,000,000 miles per year! This sophisticated operation utilizes state of the art technology to meet the needs of our more than 8 million customers.
Quality Assurance: Product Inspector (Produce) track:
This internship goes beyond a typical desk job, you'll be immersed in the core of our supply chain operations. The QA (Produce) Intern plays a hands-on role in inspecting fresh produce and other perishable items to ensure quality, safety, and compliance with Wakefern standards. This position involves physically examining inbound deliveries for grade, freshness, proper labeling, and packaging integrity, as well as monitoring temperatures and verifying weights and counts. Interns will gain first-hand experience with Wakefern's Food Safety and Quality Practices, USDA and FDA guidelines. Interns will be learning leadership skills mentored by supervisors to understand all skills required in a Quality Assurance Product Inspection department.
What you will do
Work in a refrigerated warehouse environment.
Inspects all inbound deliveries to ensure the purchased goods conform to all established product specifications, standards, and grade requirements.
Performs random organoleptic inspections of inbound goods to assure the quality, grade, and wholesomeness of the product.
Inspects all inbound deliveries for cleanliness and soundness of the transportation vehicle and the absence of cross contamination.
Monitors product temperatures by means of physical probing of goods and observation of time and temperature recording devices.
Verifies the weights and counts of received goods.
Examines all packaging for proper labeling and enforces all packaging and labeling requirements of the FDA, USDA, and USDC.
Monitors products in inventory and storage for quality and safety.
Performs daily sanitation inspections of all applicable facilities and warehouses.
Gathers and organizes all records and documentation to comply with all regulatory requirements.
Monitors all control points, critical control points, and quality control points for each of the food safety and food quality plans for the applicable perishable food facilities.
Physical demands include the ability to bend, stretch, extend, tug and pull based on inspection of various products, Ability to work in cold temperatures as low as 33 °F.
5 days on site - no remote work.
Wear OSHA-Compliant Steel Toe or Composite Safety Boots when in the warehouse is required.
Bilingual Spanish / English is a plus, but not required.
Provide coverage for the Shift Supervisors, working any 5 of the 7-days, including weekends, holidays, vacations, and peak volume periods. Interns work 40 hours per week.
Various projects as assigned.
Interns will be based out of one of the following warehouse locations and may work one of the following shifts:
Locations/Shifts
Northern Perishables - Elizabeth, NJ
5:00am-1:30pm or 6:00am-2:30pm (shift times may be later on certain days to reflect events interns are required to attend)
Produce Facility - Newark, NJ
5:00am-1:30pm or 6:00am-2:30pm (shift times may be later on certain days to reflect events interns are required to attend)
What we are looking for
Must be at least 18 years old
Must have completed 24 college credits with a 3.0 cumulative GPA or better
Will be enrolled in an undergraduate or graduate school for fall
Successful completion of a substance abuse test is required
Successful completion of a background check is required
Reliable transportation is required
Strong interpersonal, analytical, and customer service skills with the ability to multitask and manage time effectively
Excellent communication skills (written, oral, and presentation)
Strong MS Office skills (Excel, Word, and PowerPoint required)
Ability to exhibit proper business etiquette when dealing with all levels of the organization
Previous work experience in a retail environment is beneficial
Must have flexibility with regard to schedule which can include coverage for a 7-day work week, weekends, holidays, vacations and peak volume weeks (interns will work 40 hours per week)
Company Perks
Vibrant Food Centric Culture
Corporate Training and Development University
Collaborative Team Environment
Educational Workshops
Networking Opportunities
Volunteer Opportunities
Compensation and Benefits:
First year Wakefern Supply Chain/Logistic Interns will be paid at $18.00 per hour. Master Students and Returning Wakefern Supply Chain/Logistic Interns will be paid at $19.00 per hour. Interns are not eligible for company benefits including medical, dental, and vision coverage, life and disability insurance, a 401(k) retirement plan with company match & annual company contribution, paid time off and holidays.
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
Quality Specialist (2nd Shift)
Insight Global
Quality assurance specialist job in Morris Plains, NJ
Information about the Role:
QPIP - Quality Person in Plant
Shift: 2nd shift - 2pm-11pm -- As most quality/manufacturing roles onsite, we need individuals to be somewhat flexible if issues occur that would cause someone to stay later. Additionally weekend work will rotate amongst the team. They have a great team culture, and they are looking to continue to foster that type of environment. So, they are only looking for individuals who have a passion for this space, allow flexibility, and are willing to roll up their sleeves/wear multiple hats within their team.
$45-53/hr- Exact compensation may vary based on several factors, including skills, experience, and education.
Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.
Qualifications:
Bachelor's degree with a concentration in engineering, science, or an equivalent technical discipline
Minimum 5+ years of experience working within drug substance or pharma manufacturing space
Minimum 4-6 years of experience working with analytical methods i.e. flow cytometry within QC manufacturing space
Solid quality-centric experience and mindset (QA/QC) -Strong interpersonal skills both written and verbal
Ability to quickly process complex information and make critical decisions with limited information in a complex and time-sensitive environment
Experience in biologic or vaccine or cell culture products
Previous experience working with or for CMOs is required
Day-to-Day: One of our large pharmaceutical clients is looking to hire a Quality Person In Plant to join the growing External Quality team within Advanced Therapeutics. This individual will be providing Quality oversight of the analytical space. Main responsibilities will include:
-Review and approve nonconformances and deviations out of specification.
-Interface as liaison internally and externally for review/approval/implementation of change controls.
-Support monitoring of EM quality performance and proactively identify risks.
-Influence and build relationship with internal and external partners to continuously enhance quality performance.
-Interface with other functions i.e. Operations, Planning, Technical Operations, etc. as well as the external manufacturer
-Apply cGMP regulations and other FDA and international requirements to all aspects of the position.
-Provide on-site support as needed on request of the team lead
$45-53 hourly 2d ago
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.
$65k-100k yearly est. 2d ago
Tandem Certification/Testing Lead
Ltimindtree
Quality assurance specialist job in Berkeley Heights, NJ
LTIMindtree is an equal opportunity employer that is committed to diversity in the workplace. Our employment decisions are made without regard to race, color, creed, religion, sex (including pregnancy, childbirth or related medical conditions), gender identity or expression, national origin, ancestry, age, family-care status, veteran status, marital status, civil union status, domestic partnership status, military service, handicap or disability or history of handicap or disability, genetic information, atypical hereditary cellular or blood trait, union affiliation, affectional or sexual orientation or preference, or any other characteristic protected by applicable federal, state, or local law, except where such considerations are bona fide occupational qualifications permitted by law.
A little about us...
Role: Tandem Certification/Testing Lead
Location: Atlanta, GA/Berkeley heights, NJ
Job Description:
Tandem Certification Lead
8-10 years of experience in banking and cards domain
Deep understanding of Credit Card Switch Authorization platforms and the flow
Knowledge on ISO 8583 message formats and fields
Experience in Testing on Tandem Base 24 platform
Experience in scheme certification with Visa MC Amex is good to have
Good analytical skills to be able to debug issues during merchant certification
Experience in using ICC tool is good to have
Very good communication skill for handling external client communications
Skills
Mandatory Skills : Card Acquiring Domain
LTIMindtree is an equal opportunity employer that is committed to diversity in the workplace. Our employment decisions are made without regard to race, color, creed, religion, sex (including pregnancy, childbirth or related medical conditions), gender identity or expression, national origin, ancestry, age, family-care status, veteran status, marital status, civil union status, domestic partnership status, military service, handicap or disability or history of handicap or disability, genetic information, atypical hereditary cellular or blood trait, union affiliation, affectional or sexual orientation or preference, or any other characteristic protected by applicable federal, state, or local law, except where such considerations are bona fide occupational qualifications permitted by law.
We are seeking an experienced GCP Quality Assurance Auditor to join our rapidly growing biopharmaceutical company specializing in neurology and psychiatry therapies. This role ensures GXP compliance, drives quality management initiatives, and conducts internal and external audits across clinical trials, safety/pharmacovigilance, and vendor operations (CROs, CMOs, investigator sites).
The ideal candidate has extensive GCP experience, a strong pharmaceutical QA background, and expertise in radiopharmaceuticals. This is an on-site position in Northern NJ with flexible hours and minimal domestic travel.
Key Responsibilities:
Plan and perform global clinical process and vendor audits across all clinical trials
Conduct risk-based audits of clinical processes and vendors, including IRT and EDC systems
Prepare detailed audit reports and manage related non-conformances
Ensure compliance with GCP, FDA, EMA, and ICH regulations
Support regulatory inspections and quality improvement initiatives
Collaborate with clinical teams, QA, and vendor management
Qualifications:
Bachelor's degree in a scientific, healthcare, or related discipline
5+ years of pharmaceutical industry experience, including 2+ years in radiopharmaceutical QA
Extensive GCP and safety/pharmacovigilance experience
Proven experience in internal and external GXP audits
Familiarity with QMS, SOPs, clinical systems (IRT, EDC), and regulatory documentation
Strong communication and cross-functional collaboration skills
Up to 10% domestic travel
Why Join Us:
Be part of a fast-growing biopharma company making a difference in neurology and psychiatry
Hybrid work schedule with flexible hours
Opportunity for extension or full-time role
Quality assurance specialist job in Jersey City, NJ
In this role you will help enhance practices, policies and tools used by the Audit Department globally. This team offers visibility to senior members of the department!
As an Internal Audit Practices Quality Assurance Senior Auditor Associate within the Internal Audit Department, you will play a pivotal role in promoting positive transformations across the global audit department. Your participation in special projects, as needed, will also be a significant part of your role. Reporting to the Quality Assurance Core Team Manager, your contributions will be instrumental in enhancing our audit practices.
Job Responsibilities
Execute an effective program of quality assurance, including communication of results, analysis of themes, identification of best practices and recommend changes to audit processes
Positively and creatively influence department change
Seek ways to increase efficiency and effectiveness of work performed
Create and maintain key relationships across the Audit department, establishing a culture of engagement and adding value to the department
Required Qualifications, Capabilities, and Skills
3 years of audit experience or related financial services experience
Bachelor's degree
Experience in planning and executing audit projects in accordance with professional standards
In-depth understanding of audit methodologies
In-depth knowledge of financial services, with ability to evaluate appropriateness of audit results across multiple lines of business
Great communication skills, both verbal and written; must be comfortable presenting results and recommendations to senior management.
Advanced project management skills; must be able to manage multiple projects concurrently.
Preferred qualifications, Capabilities, and skills
CIA, CPA or CAMS certification desirable
Prior Quality Assurance experience
Proven track record regarding ability to maintain good working relationships and influencing change
Enthusiastic, self-motivated, effective under pressure and willing to take personal responsibility/accountabilities
$72k-120k yearly est. Auto-Apply 60d+ ago
QA Coordinator (Korean Bilingual)
Bluu, Inc.
Quality assurance specialist job in Hackensack, NJ
Location: Hackensack, NJ Employment Type: Full-time About the Role: We are seeking a detail-oriented and motivated QA Coordinator to join our team. The ideal candidate will be responsible for creating, documenting, and executing system test plans and test scripts, as well as validating data and analyzing test results. This role involves identifying, reporting, and tracking software issues, and communicating findings and progress updates with our software development team in Korea.
Key Responsibilities:
Develop, document, and execute comprehensive system test plans and test scripts.
Perform data validation and analyze test results to ensure software quality.
Record, report, track, and retest bugs found during testing.
Collaborate and communicate effectively with software developers in Korea to resolve issues.
Support continuous improvement of testing processes and documentation.
Qualifications:
Bachelor's degree in Computer Science or a related field.
Bilingual proficiency in Korean and English (both written and verbal).
1-2 years of experience in system testing of Windows-based Point of Sales (POS) software.
Hands-on experience with PC POS peripherals such as printers, barcode scanners, customer displays (CDP), and dot matrix printers.
Strong analytical, problem-solving, and communication skills.
High attention to detail and ability to work in a fast-paced environment.
Benefits:
Group Health Insurance (Medical, Dental, Vision)
Employer paid Life Insurance
Paid Sick and Vacation
401K with 3% matching
Gym Reimbursement
Company Lunch
Please visit our website ************* for more information
$51k-76k yearly est. Auto-Apply 60d+ 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 45d 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
************
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
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. 9d 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 40d 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 7d 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.
We are seeking an experienced GCP Quality Assurance Auditor to join our rapidly growing biopharmaceutical company specializing in neurology and psychiatry therapies. This role ensures GXP compliance, drives quality management initiatives, and conducts internal and external audits across clinical trials, safety/pharmacovigilance, and vendor operations (CROs, CMOs, investigator sites).
The ideal candidate has extensive GCP experience, a strong pharmaceutical QA background, and expertise in radiopharmaceuticals. This is an on-site position in Northern NJ with flexible hours and minimal domestic travel.
Key Responsibilities:
Plan and perform global clinical process and vendor audits across all clinical trials
Conduct risk-based audits of clinical processes and vendors, including IRT and EDC systems
Prepare detailed audit reports and manage related non-conformances
Ensure compliance with GCP, FDA, EMA, and ICH regulations
Support regulatory inspections and quality improvement initiatives
Collaborate with clinical teams, QA, and vendor management
Qualifications:
Bachelor's degree in a scientific, healthcare, or related discipline
5+ years of pharmaceutical industry experience, including 2+ years in radiopharmaceutical QA
Extensive GCP and safety/pharmacovigilance experience
Proven experience in internal and external GXP audits
Familiarity with QMS, SOPs, clinical systems (IRT, EDC), and regulatory documentation
Strong communication and cross-functional collaboration skills
Up to 10% domestic travel
Why Join Us:
Be part of a fast-growing biopharma company making a difference in neurology and psychiatry
Hybrid work schedule with flexible hours
Opportunity for extension or full-time role
$68k-110k yearly est. 4d 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. 16d 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. 60d+ 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
Learn more about quality assurance specialist jobs
How much does a quality assurance specialist earn in Morristown, NJ?
The average quality assurance specialist in Morristown, 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 Morristown, NJ
$81,000
What are the biggest employers of Quality Assurance Specialists in Morristown, NJ?
The biggest employers of Quality Assurance Specialists in Morristown, NJ are: