The OS is responsible for telephonically outreaching members who were recently discharged from Inpatient Care, Emergency Rooms and Outpatient Programs with a principal Behavioral Health diagnosis. The OS will be conducting a bridge visit where they assess the member's current state, review their discharge plan and assist in connecting them to appropriate aftercare services. The OS will also work collaboratively with other teams, such as Behavioral Health Case Management, to ensure the needs of our members are met.
To succeed in the role, candidates must be:
Self-motivated and able to work in a fast-paced, dynamic work environment
Possess strong attention to detail and technical abilities
Organized and able to meet deadlines
Demonstrate strong communication skills
Scope of Role & Responsabilities:
Assists members in accessing post-discharge aftercare related appointments/rescheduling new appointments.
Interfaces with members and Behavioral Health or Medical Case Management staff to coordinate aftercare activities.
Delivers crisis and emotional support when needed during telephonic outreaches. Ability to de-escalate crisis/utilize crisis intervention techniques and motivational interviewing before bridging to proper crisis services.
Meets the daily expected call volume and number of bridge visits. Self-monitors productivity and accepts supervision towards a high level of member care.
Maintains accurate and complete documentation of required information in compliance with risk management and regulatory requirements.
Shares observations and provides feedback regarding workflow to ensure continuous quality improvement.
Performs other departmental duties and participates in special/ad-hoc projects as assigned.
Required Education, Training & Professional Experience:
Master's Degree required.
Minimum 3 years of Behavioral Health (Serious Mental Illness & Substance Use Disorder) experience in managed care setting.
Minimum of 3 years' post licensing experience working directly with consumers towards their recovery.
Understanding of Medication Assisted Treatment process.
Pharmacy, Psyckes, E-Paces, HCS (UAS) MAPP knowledge.
Working knowledge of current DSM Manual and understanding of Behavioral Health diagnosis. Knowledge HEDIS/QARR strongly preferred.
Knowledge of quality improvement methodologies, i.e., PDSA, Six Sigma.
Strong technical skills (Microsoft Office, specifically MS Excel and MS Access; ability to navigate multiple computer programs and applications).
Bilingual (English/Spanish) strongly preferred.
Licensure and/or Certifcation Required:
Valid New York State license and current registration to practice as Licensed Clinical Social Worker (LCSW), Licensed Master Social Worker (LMSW), or Licensed Mental Health Counselor (LMHC).
Professional Competencies:
Integrity and Trust.
Customer Focus.
Demonstrated ability to communicate effectively, problem solve and work effectively with people.
Clear and concise written/oral communications.
Exceptional time management and organizational skills.
Ability to function in a fast-paced, dynamic work environment.
Strong interpersonal skills, the ability to remain calm and poised with challenging situations.
Self-starter who is able to perform tasks at a high level with minimal supervision.
Ability to work evenings and weekends as needed to meet department goals.
#LI-Hybrid
#MHP50
$67k-102k yearly est. 5d ago
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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. 2d ago
Quality Assurance Coordinator
Invision Staffing Services Inc.
Quality assurance specialist job in Newark, NJ
InVision is a Professional Recruitment Firm specializing in Engineering, Industrial/Skilled Trades, Information Technology and Professional Services within Canada and the U.S. We have a successful track record working on both small and large recruitment projects, across North America.
Our client is a global expert in electrical specialties and advanced materials for high-tech industries. With more than 50 industrial sites and 16 R&D centers in 35 countries around the world, they develop custom built solutions and delivers key products to its clients in order to meet the new technological challenges shaping tomorrow's world in the wind power, solar power, electronics, electric vehicles, aeronautics, space and countless other industries. They are seeking a Quality Assurance Coordinator to join them on a full-time permanent basis.
In this role Your responsibilities will include conducting audits, developing quality control plans, implementing corrective actions, and collaborating with cross-functional teams to drive continuous improvement in quality processes.
Key Responsibilities
Responsible for Incoming Inspection of specific items and final Inspection of all products
Enter all orders inspected into finished goods and generate pick lists.
Approve all setups for in house hardware and perform FAI and generate FAIR.
Responsible for dealing with quality issues with incoming materials from suppliers.
Support QA team in inspection processes whenever needed, and the preparation inspection reports.
Support production on questions relating to drawings, visual quality, verifying last off or set-up.
Foster positive relationships with stakeholders through effective communication.
Follow ISO and Health C Safety policies and procedures.
Contribute to the development and maintenance of a positive quality culture within the organization.
Perform other duties as directed by the QA manager.
Develop and maintain quality control plans, procedures, WI, SOP's, and protocolsto ensure adherence to quality standards.
Coordinate and conduct internal audits to assess compliance with quality management systems and identify areas for improvement.
Lead the development and implementation of corrective and preventive actions
(CAPA) to address quality issues and prevent recurrence.
Handle quality issues with incoming materials from suppliers and customer
complaints, including initiating Non-Conformance Reports (NCR) and managing
Return Material Authorizations (RMA).
Handle administrative components of customer complaints and various qualityreports. Monitor Customers portals.
Monitor and analyze quality metrics and performance indicators to track progressand identify trends or patterns.
Collaborate with production, engineering, and other departments to address quality-related issues and drive product improvements.
Prepare and complete quality documentation, such as CONQ, PPAP, FAIR reports, Source Inspection Report & any special inspection report.
IQS and QMS drive ownership
Manage quarantine cage and maintain its log. Handle on-hold material.
Provide guidance and training to staff on quality processes, standards, and best practices.
Facilitate communication and collaboration between cross-functional teams to promote a culture of quality excellence.
Participate in customer audits and inquiries related to quality assurance processes and procedures.
Participate in supplier evaluations and audits to ensure quality standards are met throughout the supply chain.
Monitor and analyze quality metrics and performance indicators to drive continuous improvement initiatives.
Assist in the preparation and submission of quality-related reports and documentation to regulatory agencies as required.
Qualifications
3 college or technical school or Quality Program, and 3+ years of Quality
Assurance and Quality Control experience.
Experience with completing FAI reports and conducting a supplier audit.
Experience with following manufacturing processes: casting, machining, sheet
metal work, surface treatment, plastics thermoset processing would be an asset
Experience with ISO 9001 standards
Ability to communicate in English, both verbally and in writing. French or Spanish would be an asset.
ITAR facility must be a US citizen or green card holder
Strong leadership and team management capabilities
Excellent problem-solving and decision-making skills
Knowledge of ERP/MRP systems (JDE, SAP, Oracle, Microsoft Dynamics, etc.)
Employment Rewards:
Full Time Permanent
Benefits (medical, dental, vision)
Paid Time Vacation
Annual Bonus
401K + Match
Application Process:
All Qualified candidates will be contacted.
InVision is an Equal Opportunity Employer and Prohibits Discrimination and
Harassment of Any Kind:
It is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment.
$51k-76k yearly est. 5d ago
QC Associate
Blue Nile 4.3
Quality assurance specialist job in New York, NY
Perform detailed inspections of in process jewelry products throughout the manufacturing process, including rings, necklaces, bracelets, earrings, and other accessories, to ensure they meet established quality standards and specifications. Provide fe Associate, QC, Jewelry, Manufacturing
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. 25d ago
OTC Derivatives Documentation Specialist
Jane Street 4.4
Quality assurance specialist job in New York, NY
We are looking for an OTC Derivatives Lawyer/Documentation Specialist to handle Jane Street's global OTC derivatives confirmations review process. In this role, you'll collaborate closely with our internal Legal, Operations, and Trading teams-and liaise directly with external counterparties-to facilitate prompt, accurate reviews and negotiations of trade confirmations and related documentation. While you'll be based in New York, your daily work will cover activity across our global offices in New York, London, and Hong Kong.
Additional responsibilities of this role will include:
Drafting, reviewing, and negotiating confirmations for equity, FX, and interest rate derivatives
Managing a system for tracking OTC derivatives documentation across all Jane Street offices
Working with our Legal and Trading teams to create, maintain, and update confirmation templates, and identifying the appropriate confirmation template for each trade
Assisting with legal review of trade confirmations
Comparing terms and identifying discrepancies to ensure accuracy and consistency
Sending comments to counterparties and negotiating as needed
Monitoring communications with counterparties and acting as a point of contact for the desk, Legal, and counterparties
Following up to have negotiated confirmations reissued where appropriate
Checking coverage under existing master confirmation agreements
Obtaining signatures and collecting and returning fully executed copies to and from counterparties
Matching counterparty questionnaires on IHS Markit
Documenting and improving processes to maximize efficiency across teams
About You
Have 5+ years of experience working as a negotiator in financial services, or in-depth relevant experience over a shorter period (having a JD is preferred but not required)
Deeply familiar with master documentation governing OTC derivatives, including: the Equity Derivatives Definitions, Interest Rate Derivatives Definitions, and the FX and Currency Option Definitions, as well as Master Confirmations and Long Form Confirmations
Organized with exceptional attention to detail and accuracy
Strong written and verbal communicator
Self-motivated professional who is process orientated and has a proven ability to design and implement organizational systems that drive efficiency
Reliable, positive, dedicated, and flexible team player
Have a strong client service and teamwork mentality
Able to handle competing priorities and work effectively in a fast-paced environment
If you're a recruiting agency and want to partner with us, please reach out to **********************************.
$91k-122k yearly est. Auto-Apply 4d 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
Senior Coordinator, Quality Assurance
Us Pharmalab Inc.
Quality assurance specialist job in North Brunswick, NJ
The Senior QA Coordinator plays a key role in supporting the Quality Assurance department by ensuring compliance to SOPs, batch records, master manufacturing records, GMP documentation and to 21 CFR Part 111 and 117 and other relevant quality standards in the nutraceutical manufacturing environment.
This position will be responsible for coordinating quality assurance programs designed to ensure continuous production of products and includes tracking products, materials, status, and location. Involved in the issuance /review of batch records, on floor collection of samples , preparation of Master compliance documents and participating in audit preparations .
Areas of Responsibility
Oversee and maintain GMP documentation systems, including SOPs, batch records, deviations, CAPAs, change controls, and training records.
Issuance of Manufacturing / Coating / Packaging Batch Cards
Collects samples from on floor production for further testing and retention
Distributes testing samples to Inhouse testing Analytical , Elemental and Microbiology Lab
Preparation of different types of In process Labels for production , QA samples to be provided along with the Batch Records
Scanning , photocopy, filing of GMP documents per Batch Product requirements
Coordinate Finished Product release in Syspro
Performs Sampling of materials / products per procedures as needed
Reads and understands approved specifications/standards assigned to the project
Keeps up to date with the regulatory requirements around documentation and implements changes if necessary.
Work with internal teams to obtain an in-depth understanding of the processes and documentation requirements.
Collaborate with Manufacturing, R&D, QC, and Regulatory teams to ensure seamless execution of quality processes.
Play an active role on quality management team within the organization
Any other duties which may be assigned from time to time
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:
Bachelor's degree in Life Sciences, Chemistry, Biology, or a related field.
Minimum 3-5 years of QA experience in a nutraceutical, dietary supplement, or pharmaceutical manufacturing environment.
Strong knowledge of GMP, 21 CFR Part 111,117 and other relevant quality standards.
Detail-oriented with strong organizational and documentation skills.
Proficient in Microsoft Office; experience with electronic Quality Management Systems (eQMS) preferred.
Excellent communication and problem-solving skills.
Certifications, Licenses, Credentials:
N/A
Skills & Ability
In-depth understanding of nutraceutical manufacturing processes and regulatory compliance.
Proficient in QA documentation, process audits, and deviation handling.
Strong analytical and decision-making skills.
Familiar with QMS tools, GMP documentation, and data integrity principles.
Working knowledge of SOP writing, change control, and risk assessment.
Physical Requirements (lifting, etc.):
Ability to lift up to 35 lbs.; occasionally lift and move up to 50 pounds.
Must stand and walk on production floor a minimum of 6 hours per shift
Uses hands to finger, handle, feel, or operate objects or controls, lifting to waist height and/or above shoulder height, frequent bending from waist, or squatting, walking short distances.
Occasionally works from a rolling ladder or step stool.
Must be able to wear all PPE including lab coat, face mask, booties, gloves, safety glasses.
Work Environment (Office, Warehouse, temperature extremes, etc.):
Work is regularly performed inside a manufacturing and packaging environment where temperatures can be moderate, exposure to dust, odors, noise, and fumes. The noise level is usually moderate. Employees can be exposed daily to chemicals and cleaning agents.
The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all the job responsibilities, duties, skill, or working conditions. In addition, this document does not create an employment contract, implied or otherwise, other than an "at will" relationship.
USPL is proud to be an Equal Opportunity Employer.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity or expression, national origin, age, genetic information, disability, protected veteran status, or any other characteristic protected by applicable local, state, or federal law.
Benefits And Compensation: Our benefits are designed to help you move forward in your career, and in areas of your life outside of USPL. From health and wellness benefit options including: medical, dental, vision, short and long term disability, basic life insurance, supplemental life insurance, AD&D insurance. We also offer a matched 401(k) savings plan. Employees have the opportunity to receive compensation in the form of premium pay such as overtime, shift differential, holiday pay, sick time, etc. Newly hired employees receive up to 10 days of vacation the first year, which grows to 12 days starting the second year of employment.
Acknowledgement
I have read and understand the job requirements, responsibilities, and expectations set forth in the job description provided for my position. I attest that I can perform the essential job functions as outlined with or without any reasonable accommodations.
shift schedule :- General Shift 8.30am - 5.00 pm or extended
$51k-76k yearly est. Auto-Apply 5d ago
QA Associate
Artech Information System 4.8
Quality assurance specialist job in Morris Plains, NJ
Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.
Job Description
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. 3d ago
Associate, In-Process QA, MG/PG
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.
USPL is proud to be an Equal Opportunity Employer.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity or expression, national origin, age, genetic information, disability, protected veteran status, or any other characteristic protected by applicable local, state, or federal law.
Benefits And Compensation: Our benefits are designed to help you move forward in your career, and in areas of your life outside of USPL. From health and wellness benefit options including: medical, dental, vision, short and long term disability, basic life insurance, supplemental life insurance, AD&D insurance. We also offer a matched 401(k) savings plan. Employees have the opportunity to receive compensation in the form of premium pay such as overtime, shift differential, holiday pay, sick time, etc. Newly hired employees receive up to 10 days of vacation the first year, which grows to 12 days starting the second year of employment.
shift schedule
3rd shift: 11:00 PM - 7:30 AM
3rd Shift - 11:00 PM to 7:30 AM
$50k-73k yearly est. Auto-Apply 16d ago
Assurance Associate, Information Systems Assurance - Summer 2026 (New York)
BDO USA 4.8
Quality assurance specialist job in New York, NY
As an Assurance Associate, Technology Risk Assurance, you will begin to utilize your educational background as well as your organizational skills as you serve the firm's dynamic client base. You will assist in problem solving and fact-finding, working side-by-side with more experienced team members who can provide you with direction, coaching and learning opportunities. You will have the opportunity to gain an understanding of the IT environment during fieldwork by interviewing various client personnel and performing an IT general controls risk assessment in various areas including, but not limited to new hire and terminated user controls testing, user access controls testing, and program change controls testing. Further, you will have an opportunity to work within engagement teams to develop recommendations that will help clients improve their controls environments and help develop audit strategies to respond to controls findings you discover.
Job Duties:
Assists in performing audit engagements, including risk assessments of various companies' IT environments, consisting of - but not limited to - access administration, program change management, operations, and logical access security
Provides input to management leaders on suggestions to improve client internal controls and procedures
Maintains relationships with and speaks to key client personnel to obtain an understanding of IT and business operations, processes, and functions
Assists the core financial audit team in identifying controls issues, analyzing the potential impacts of those issues on the respective audits, and developing compensating controls and substantive audit strategies to be carried out among the team
Document work completed by preparing workpapers
Assist engagement teams in applying tools and data analytics to enhance effectiveness and efficiency in audits
Other duties as required
Supervisory Responsibilities:
Opportunities are available to train and mentor interns and incoming associates after your first year as an Associate
Qualifications, Knowledge, Skills and Abilities:
Education:
Bachelor's degree in Accounting, Information Systems, or Information Technology, required
Experience:
Prior internship or work study experience of information systems and operational auditing experience, preferred
License/Certifications:
Actively pursuing (or committed to) completion of one of more of the following certification exams: CISA, CISSP, CPA, CITP, CIA, or other relevant certification, required
Software:
Proficient in the use of Microsoft Office Suite, preferred
Exposure to various industry ERP applications, highly preferred
Language:
N/A
Other Knowledge, Skills & Abilities:
Excellent verbal and written communication skills
Strong analytical and basic research skills
Solid organizational skills especially ability to meet project deadlines with a focus on details
Ability to successfully multi-task while working independently or within a group environment
Proven ability to work in a deadline-driven environment and handle multiple projects simultaneously
Basic knowledge of internal controls
Ability to travel as necessary
Individual salaries that are offered to a candidate are determined after consideration of numerous factors including but not limited to the candidate's qualifications, experience, skills, and geography.
California Range: $85,000 - $90,000
Colorado Range: $73,000 - $77,000
Illinois Range: $78,000 - $82,000
Maryland Range: $83,000 - $87,000
Massachusetts Range: $83,000 - $87,000
Minnesota Range: $70,000 - $74,000
New Jersey Range: $78,000 - $82,000
NYC/Long Island/Westchester Range: $83,000 - $87,000
Ohio Range: $71,000 - $75,000
Washington Range: $78,000 - $80,000
Washington DC Range: $83,000 - $87,000
SourcePro Search is seeking a Quality Assurance Assistant with a Bachelor's Degree in Quality Assurance, Food Science, Biology, Microbiology, Operations Management, or a related field. The ideal candidate will have experience in USDA and FDA food manufacturing, and be bilingual in English and Spanish.
The Quality Assurance Assistant is responsible for ensuring that food products meet standards set by both the company and regulatory authorities. The QA Assistant will assist the Director of Food Safety & Compliance to further quality and safety policies and procedures.
Must be knowledgeable about food safety standards that are customary within the food industry and mandated by government regulations. The Quality Assurance Assistant is expected to be familiar with the Hazard Analysis and Critical Control Points (HACCP) management system required by the Food and Drug Administration (FDA) and some other standards like SQF or BRC.
What You'll Do:
·Perform Daily Product Evaluations and Cook Study Validations. Follow through with the team for corrective actions.
·Understand and implement quality assurance policies and procedures
·Collect and maintain supplier documentation
·Evaluate adequacy of quality assurance standards
·Investigate customer complaints and non-conformance issues
·Collect and compile statistical quality data
·Analyze data to identify areas for improvement in the quality system
·Monitor corrective and preventive actions
·Prepare reports to communicate outcomes of quality activities
·Identify training needs and organize training interventions to meet quality standards
·Monitor risk management activities
·Assure ongoing compliance with quality and industry regulatory requirements
What You'll Bring:
·Bachelor's Degree in Quality Assurance, Food Science, Biology, Microbiology, Operations Management or a related field.
·USDA and FDA food manufacturing experience
·Bilingual (Spanish)
·PCQI (Preferred)
·HACCP Certified (Preferred)
·Strong verbal and written English communication skills
·Strong implementation and execution skills
·Good organizational and planning skills
·Ability to be relatable, personable, and productive within a team environment
Work Relationships and Scope:
·Reports directly to the Director of Food Safety & Compliance Director.
·Develops good working relationships with the management, co-workers, and other employees.
·Develops working knowledge of the production environment, equipment and can respond to change.
·Develops knowledge of federal, state, and local food safety regulations.
Working Conditions:
·This position works in a production environment with the risk of injury.
Physical Demands:
To successfully perform the essential functions of this role the individual must be able to meet the following requirements, though reasonable accommodation may be made to enable and individual with disabilities.
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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.
Join JPMorgan Chase as a Liquidity Reporting Senior Associate! The Treasury/Chief Investment Office Liquidity Controller Americas group is responsible for oversight of North America & Latin America's liquidity results and related controls. This includes managing the regional liquidity reporting, its operational control environment, and liquidity forecasting and analysis. The group is also involved in projects, including those relating to enhancing the Liquidity Risk Infrastructure platform, conducting strategic analyses, and participating in various governance forums. Additionally, the group is the primary point of contact for Investor Relations and Corporate Reporting where liquidity messaging is involved.
As a Liquidity Reporting Senior Associate within the Treasury/Chief Investment Office, you will act as the lead tester for the Liquidity Reporting Quality Assurance Program. You will develop a strong understanding of the Liquidity reporting as well as its production processes and gain insight into the Firm's Liquidity Reporting Infrastructure.
Job responsibilities:
Test and review transactional Liquidity reporting data for a variety of the Firm's financial products that are used in creating the Firm's external liquidity reports (6G/US LCR/US NSFR)
Be responsible for all workpaper documentation, SOP production and senior management reports
Present quarterly testing results to Liquidity Senor Management and coordinate testing with our support team in India and our testing team in EMEA
Act as additional point of contact with any Internal Audit/Regulator inquiries
Support the external Liquidity reporting prepared for disclosure in the Firm's 10-K/10-Q and the Press Release
Collaborate in determining, producing, and validating relevant liquidity information and PowerPoint presentations for the CFO's Press Release Q&A preparation, working closely with the Liquidity and Capital Management team and Investor Relations
Required qualifications, capabilities, and skills:
Bachelors' degree required
3 years work experience in liquidity reporting, control testing, quality assurance, data validation or internal audit
General understanding of the bank's externally published LCR and NSFR reporting
Working knowledge of Microsoft Suites, strong Excel skills required
Strong financial and analytical skills
Ability to work independently using initiative and ability to manage your own work
Highly numerate with a methodical approach to problem solving
Strong relationship building, communication skills, time management, and organization skills
Ability to work independently using initiative and ability to manage your own work
Preferred qualifications, capabilities, and skills:
Alteryx skills preferred
Experience with technology project testing a plus
$52k-76k yearly est. Auto-Apply 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 5d ago
Quality Assurance Associate III
Lynkx Staffing LLC
Quality assurance specialist job in Saddle Brook, NJ
Quality Assurance Associate IIIAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Quality Assurance Associate III is responsible for performing Quality Assurance activities within minimal supervision of daily tasks in support of Quality Systems and/or client procedures including but not limited to document management, issuance, review and approval of batch records, SOPs, Qualification and Validation Reports; review of QC data; perform material releases and final product releases; review of Deviations as well as assists Quality management with department needs. He/she exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. This role manages internal and external audits which may include interaction with Health Authorities and clients
Interfaces directly with client and cross functional teams
Provides resolutions pertaining to quality for project related issues
Independently prioritize, schedule, and manage multiple projects and resources (team)
Ensures the safe release of cellular products in accordance with company and/or client procedures and requirements.
Ensure and promote compliance with applicable CGMP and GTP regulations and company and client SOPs
Able to provide input based on knowledge and experience on quality systems and procedures and CGMP/GTP issues.
Author and review relevant SOPs, validation and other documents.
Responsible for the timely issuance, review and approval of QC certificates, closure of Batch Records, and deviation reports.
Responsible for the completion of all client requirements related to cellular product and/or material releases.
Master Batch Record Control, distribution and label verification
Perform line clearance activities as required.
Assignment and maintenance of product Lot numbers as applicable.
Perform internal documentation audits as assigned.
Materials management nonconformance disposition and release activity as applicable.
Responsible for accurate deviation reporting as applicable and tracking/trending follow up actions to closures
Evaluate and investigate deviation reports and initiate and coordinate corrective and preventive actions.
Track and trend relevant quality metrics including environmental monitoring data.
Provide Quality Assurance related support to various departments.
Interface with suppliers and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies.
Electronic Document Control activities as assigned.
Provide training to personnel as assigned by supervisor.
Travel may be required.
REQUIREMENTS
BS in biological sciences or other relevant field of study
5 years + experience in QA in a life sciences company company with a strong focus in the manufacturing and/or testing of biologics.
Working knowledge and technical understanding of aseptic manufacture of biologics
Understanding of quality system applications
Experience in both clinical and commercial manufacturing is preferred.
Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (validation/qualification reports, SOPS. Etc.
Experience in organizing teams for effective and timely completion of projects.
Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc.
Experience participating in or hosting health authority inspections and/or client audits.
Computer skills (Microsoft Office, Outlook)
Detail-oriented and organized
Analytical and problem-solving skills
Good written and oral communication skills
Ability to multi-task and be adaptable
Flexible and able to adapt to company growth and evolving responsibilities
Ability to work independently and with a team
Strong Project Management and organization skills
Must have the ability to work in a team-oriented environment and with clients
Must be able to work during the weekend, holidays and as required by the company
May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, etc. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
$50k-73k yearly est. 27d ago
Quality Assurance Associate II
Minaris
Quality assurance specialist job in Allendale, NJ
The Quality Assurance Associate II (1st Shift, Tuesday-Saturday, 8:00 am- 4:30 pm) is responsible for performing Quality Assurance activities under direct supervision of daily tasks in support of Quality Systems and/or client procedures including but not limited to document management, review of QC data, material releases and final product releases as well as assisting Quality management with department needs.
Essential Functions and Responsibilities
Regular and reliable attendance on a full-time basis.
Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company's policies and practices.
Embodies Minaris Advanced Therapies values and aligns daily actions with department and company culture.
Ensures that all procedures and processes meet internal quality standards as well as external regulations specific to pre-clinical, clinical and commercial manufacturing.
Read, understand and follow all cGMP and cGTP documentation for Quality System Functions (SOPs,WIs,etc.)
Maintain cGMP and cGTP compliance for all aspects of pre-clinical, clinical and commercial manufacturing.
Release raw material in ERP system as well as on paper.
Perform Accessioning of incoming Apheresis.
Review Batch record and disposition material of finished product to client.
Provides information for Out of Specification and deviations to investigator.
Performs line clearance prior to manufacturing operations begins.
Other duties as assigned.
Knowledge, Skills & Ability
Relevant computer skills (Microsoft Office, Outlook)
Detail-oriented and organized
Analytical and problem-solving skills
Good written and oral communication skills
Ability to multi-task, prioritize, time manage and be adaptable
Flexible and able to adapt to company growth and evolving responsibilities
Ability to work independently and with a team
Education & Experience
BS or higher education degree in a scientifically related field
Experience in a biologics or biotechnology company (1 -3 years)
Working knowledge and technical understanding of the aseptic manufacture of biologics preferred
Working knowledge of GMP and TCTP regulations
Experience in reviewing GMP/GCTP related documents (validations/qualifications reports, SOPs, etc.)
Disclaimer
The above information in this description is intended to describe the general nature and level of work performed. It does not contain nor is it intended to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job. Duties, responsibilities, and activities may change at any time with or without notice.
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.
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$70k-93k yearly est. 2d 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
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$53k-71k yearly est. 3d ago
Associate, In-Process QA, MG/PG
USPL Nutritionals LLC
Quality assurance specialist job in North Brunswick, NJ
Date
06/2025
Title
Associate, In-Process Quality Assurance MFG/PKG
Department
Quality Assurance Operation Support
Reports to
Quality Assurance Manager/ VP of QA
FLSA (Exempt or Non-Exempt
Non-Exempt
Role Overview
The IPQA performs line inspection as part of the cGMP, SOPs, and policy compliance requirements as per CFR part 111. Performs In-process quality testing in manufacturing and/or packaging areas according to prescribed timelines and accurately captures test results in batch records. The Inspector performs calibrations & measurements on raw materials, bulk products, finished products and packaging components as required in batch records and SOP's. This position reports to the QA Manager and is a key member of the Quality Assurance group. The IPQA Associate is a highly organized self-starter who can work independently, demonstrates a positive attitude, and a bias for action.
Areas of Responsibility
IPQA - Level 1: To support In-process quality assurance activities by performing routine checks and verifications during manufacturing and/or packaging of nutraceutical products. This role ensures that all processes comply with applicable GMP, SOPs, and regulatory requirements.
Key Responsibilities:
???? Manufacturing Support
Perform line clearance before starting blending, granulation, compression, encapsulation, coating processes.
Perform In-process checks:
Blend uniformity sampling
Tablet/capsule weight variation
Hardness, friability, and disintegration tests etc as applicable
Verify equipment cleaning and area hygiene as per SOP.
Collect and label In-process and stability samples under supervision.
???? Packaging Support
Ensure line clearance before packaging activities.
Perform In-process checks:
Batch number and expiry date printing
Label application and carton sealing
Primary and secondary packaging integrity etc as applicable
Assist in reconciliation of packaging materials (e.g., printed cartons, leaflets, labels).
???? Documentation
Record observations in IPQA checklists, logbooks, and batch records.
Maintain GMP documentation in real-time (legible and error-free).
Escalate any deviation or abnormality immediately to the QA Executive/Supervisor.
???? Compliance & Safety
Adhere to company GMP, SOP, and Hygiene policies.
Use PPE appropriately.
Support during internal/external audits by providing necessary records.
Cleans up work following the completion of a shift.
Meets all safety expectations and follows all safety practices.
Works extended hours and occasional weekend overtime.
Other duties as assigned
Other Responsibilities Including Safety:
IPQA - Level 2: To independently perform and document In-process quality assurance activities at all critical stages of manufacturing and packaging of nutraceutical products, ensuring compliance with GMP, SOPs, and regulatory requirements.
Key Responsibilities:
???? Manufacturing Stage (Granulation, Blending, Compression, Encapsulation, Coating )
Carry out and document line clearance activities before starting each manufacturing batch.
Conduct in-process checks independently:
Blend uniformity sampling
Tablet/capsule weight variation
Hardness, friability, thickness, and disintegration
In-process controls as per BMR specifications
Verify equipment cleanliness status, calibration, and logbook entries.
Monitor and record environmental conditions in production areas (temperature, RH, differential pressure).
???? Packaging Stage
Conduct line clearance for primary and secondary packaging (bottles, strips, blister, cartons).
Perform and document:
Batch coding verification (batch no., Mfg/Exp date)
Packaging material correctness (labels, leaflets, cartons)
Sealing integrity checks (blisters, induction seals)
Online rejection bin and reconciliation checks
Ensure correct usage of approved packaging materials with status labels.
???? Documentation & Compliance
Fill Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) in real-time.
Record IPQA observations and results as per SOPs ( legible and error free).
Initiate and report deviations, OOS/OOT, and non-conformities to QA Supervisor/ Manager.
Support CAPA implementation and change controls.
???? General QA Duties
Ensure compliance with GMP, GLP, and data integrity principles.
Follow gowning protocols, hygiene, and safety measures in production areas.
Assist during internal audits and regulatory inspections by providing accurate documentation and data.
Cleans up work following the completion of a shift.
Meets all safety expectations and follows all safety practices.
Works extended hours and occasional weekend overtime.
Other duties as assigned
Other Responsibilities Including Safety:
IPQA - Level 3: To lead and monitor In-process QA activities during nutraceutical manufacturing and packaging operations. Ensure compliance with GMP, regulatory standards, and internal SOPs by supervising IPQA teams, reviewing records, and addressing quality deviations.
Key Responsibilities:
????IPQA Oversight - Manufacturing & Packaging
Supervise and verify line clearance activities across all manufacturing and packaging areas.
Ensure compliance with critical process parameters (CPPs) and critical quality attributes (CQAs).
Review and approval:
In-process checks: weight variation, hardness, friability, disintegration etc as applicable
Environmental monitoring records
Equipment and area cleaning records
Coordinate and monitor sampling activities for In-process, finished products and stability studies.
???? Review and Verification
Review and verify completed Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR).
Cross-check reconciliation of raw materials and printed packaging materials.
Verify proper use of status labels (approved/rejected/quarantine).
???? Deviation & CAPA Management
Investigate and document process deviations, non-conformances, and OOS/OOT incidents.
Lead root cause analysis (RCA) and implement Corrective and Preventive Actions (CAPA).
Coordinate with cross-functional teams (Production, QC, Regulatory Affairs) to ensure closure of quality events.
???? Audit & Compliance
Ensure readiness for internal, external, and regulatory audits (FSSAI, WHO-GMP, USFDA, etc.).
Conduct routine GMP audits, spot checks, and area inspections.
Train shop-floor personnel on data integrity, documentation practices, hygiene, and gowning protocols.
???? Team Coordination
Guide and mentor IPQA Level 1 and Level 2 personnel.
Allocate daily QA responsibilities and monitor adherence to QA procedures.
Conduct on-the-job training for new team members
Cleans up work following the completion of a shift.
Meets all safety expectations and follows all safety practices.
Works extended hours and occasional weekend overtime.
Other duties as assigned
Other Responsibilities Including Safety:
Meets all safety expectations and follows all safety practices.
Works extended hours and occasional weekend overtime.
Other duties as assigned
Other Responsibilities Including Safety:
N/A
Other Responsibilities Including Safety:
Works in a safe and responsible manner to create an injury-free and incident-free workplace.
Complies with all job-related safety and other training requirements.
Keeps management informed of area activities and of any significant problems.
Requirements
Education & Qualification:
IPQA - Level 1:
0-1 year (Freshers with training or internship in QA preferred)
Or equivalent combination of education and experience.
High School diploma is required; BS degree in a life science discipline (e.g., Chemistry, Microbiology, Biochemistry) a plus.
IPQA - Level 2:
Minimum of 3+ years of experience in a QA Inspector within a nutritional's supplements, food, consumer products or pharmaceutical company.
Or equivalent combination of education and experience.
BS degree in a life science discipline (e.g., Chemistry, Microbiology, Biochemistry) a plus.
IPQA - Level 3:
3-5 years in IPQA or related QA roles in nutraceuticals, pharmaceuticals, or food manufacturing. Or equivalent combination of education and experience.
BS degree in a life science discipline (e.g., Chemistry, Microbiology, Biochemistry) a plus.
Certifications, Licenses, Credentials:
N/A
Skills & Ability
IPQA - Level 1:
Basic understanding of GMP, nutraceutical processes, and QA principles.
Good observation and attention to detail.
Willingness to work in production areas (shifts, growing zones).
Ability to follow instructions and standard procedures accurately.
Basic proficiency in English and documentation practices.
IPQA - Level 2:
Strong knowledge of IPQA functions, SOPs, and process flow in nutraceuticals.
Understanding of basic analytical parameters (weight variation, friability, etc.).
Good documentation and observational skills.
Proficient in using basic lab and QA tools (weighing balances, disintegration testers).
Familiar with regulatory guidelines (FSSAI, WHO-GMP, USFDA, HACCP).
IPQA - Level 3:
In-depth understanding of nutraceutical manufacturing processes and regulatory compliance.
Proficient in QA documentation, process audits, and deviation handling.
Strong analytical and decision-making skills.
Familiar with QMS tools, GMP documentation, and data integrity principles.
Working knowledge of SOP writing, change control, and risk assessment.
Physical Requirements (lifting, etc.):
Ability to lift up to 35 lbs.; occasionally lift and move up to 50 pounds.
Must stand and walk on production floor a minimum of 6 hours per shift
Uses hands to finger, handle, feel, or operate objects or controls, lifting to waist height and/or above shoulder height, frequent bending from waist, or squatting, walking short distances.
Occasionally works from a rolling ladder or step stool.
Must be able to wear all PPE including lab coat, face mask, booties, gloves, safety glasses.
Work Environment (Office, Warehouse, temperature extremes, etc.):
Work is regularly performed inside a manufacturing and packaging environment where temperatures can be moderate, exposure to dust, odors, noise, and fumes. The noise level is usually moderate. Employees can be exposed daily to chemicals and cleaning agents.
The above statements are intended to describe the general nature and level of work being
performed by people assigned to this job. They are not intended to be an exhaustive list of all the job responsibilities, duties, skill, or working conditions. In addition, this document does not create an employment contract, implied or otherwise, other than an "at will" relationship.
USPL is proud to be an Equal Opportunity Employer.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity or expression, national origin, age, genetic information, disability, protected veteran status, or any other characteristic protected by applicable local, state, or federal law.
Benefits And Compensation: Our benefits are designed to help you move forward in your career, and in areas of your life outside of USPL. From health and wellness benefit options including: medical, dental, vision, short and long term disability, basic life insurance, supplemental life insurance, AD&D insurance. We also offer a matched 401(k) savings plan. Employees have the opportunity to receive compensation in the form of premium pay such as overtime, shift differential, holiday pay, sick time, etc. Newly hired employees receive up to 10 days of vacation the first year, which grows to 12 days starting the second year of employment.
shift schedule
3rd shift: 11:00 PM - 7:30 AM
3rd Shift - 11:00 PM to 7:30 AM
$50k-73k yearly est. 18d ago
Learn more about quality assurance specialist jobs
How much does a quality assurance specialist earn in Elizabeth, NJ?
The average quality assurance specialist in Elizabeth, 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 Elizabeth, NJ
$81,000
What are the biggest employers of Quality Assurance Specialists in Elizabeth, NJ?
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