QA Technician Jobs in New Jersey

Job Title: Quality Assurance Specialist Company: Prudential Real Estate Location: Newark, NJ Description: The individual is part of the Market Risk Management / Annuity Hedging department of Prudential Annuities, which is responsible for the day-to-day management and strategic oversight of Prudential's variable annuity hedging programs. This position will work with the technology team providing state-of-the-art innovative hedging technology solutions for the hedging program. The successful candidate will be specifically responsible for Quality Assurance support which includes functional, regression, performance, and stress testing. The candidate will work under the supervision of the QA Lead Specialist. Responsibilities: · Test schedules, test strategy/plans, test cases, and test reports · Perform black-box and/or white-box software testing as needed · Participate in preparation of quality assessments, reports, and metric · Debug complicated problems. Qualifications: · Experienced with test automation for functional and regression testing required (Selenium RC toolset preferred) Experience testing in a java environment · Design and build automated and manual test suites · Working knowledge of Jira, TestLink, JMeter or similar tools. · Experience using continuous integration tools · Ability to write and understand SQL queries to perform data verification and set up test data. · Extensive knowledge of software engineering, quality assurance and implementation

Job Title: 105231 QA Specialist Company: LabCorp Location: West Trenton, NJ Description: Laboratory Corporation of America® Holdings (LabCorp), an S&P 500 company, is a pioneer in commercializing new diagnostic technologies and the first in its industry to embrace genomic testing. With annual revenues of $3.6 billion in 2006, more than 25,000 employees nationwide, and more than 220,000 clients, LabCorp offers clinical assays, ranging from routine blood analyses to HIV and genomic testing. LabCorp combines its expertise in innovative clinical testing technology with its Centers of Excellence: The Center for Molecular Biology and Pathology, National Genetics Institute, Inc., ViroMed Laboratories, Inc., The Center for Esoteric Testing, DIANON Systems, Inc., US LABS, and Esoterix. Our clients include physicians, government agencies, managed care organizations, hospitals, clinical labs, and pharmaceutical companies.BenefitsWith a career at LabCorp, you'll be connected to the lives of people worldwide. But we know, there is one life that is constantly on your mind - yours. That's why our benefits are designed to take care of the most important life essentials, so you don't have to. LabCorp's benefits program is designed to meet your personal needs by offering you choice and flexibility. Heathcare? Medical? Dental? Optical? Health Care Flexible Spending Accounts? Dependent Care Flexible Spending AccountsFinancial Security? Cash Balance Retirement Plan? Employees' Savings Plan (401K) with Company Match? Employee Stock Purchase Plan? Basic Life Insurance? Business Travel Accident Insurance? Dependent Life Insurance? Long-Term Disability Insurance? Optional Accidental Death and Personal Loss (AD&PL) Insurance? Optional Life? Short Term Disability Insurance? Specified Critical Illness Insurance? Whole Life InsuranceLife Balance Programs? Adoption Assistance Program? Auto and Homeowner's Insurance ? Credit Union Membership? Employee Assistance Program? Legal Assistance Program? Health Management Programs? NextSteps? Lifestyle Improvement ProgramsCareer Development? EXcell Mentoring Partnership Program? LabCorp CBCS University? LabCorp Executive Development Program? Supervisor Development Training? Tuition Refund PlanCommunity Involvement? Matching Gift Program? Personal Leave Bank Donation? Volunteer Program105231 QA SpecialistWest Trenton, NJ Job Description : Assuring compliance through the performance of project, process-based and facility inspections; auditing of bioanalytical and immunoanalytical data and technical reports; provide training to technical and professional staff in GLP regulations; serve as a resource on regulatory issues and GXP compliance; and participate in outside agency or sponsor-related inspections or inquiries as required. The major duties and responsibilities of the Senior Quality Assurance Specialist (NJ) include the following: 1. Possess a sound background in GLP compliance and a general knowledge of GCP compliance. 2. Familiar with all aspects of FDA and other applicable international regulations. 3. Responsible for conducting and reporting audits and inspections of facilities, projects, reports. 4. Audit support operations to assess compliance with FDA GLP regulations and industry standards. 5. Interpret complex and evolving regulatory requirements and intent. 6. Resolve regulatory compliance issues and provide regulatory support to the Laboratory. 7. Understand required document database management and archiving methods. 8. Assist in the continued development and guidance of administration programs to promote and monitor the quality and performance of operations as they relate to both pre-clinical and clinical projects. 9. Assess overall compliance with protocols, SOPs, company policies, and applicable regulations. 10. Maintain proficiency on regulatory compliance issues and provide required training to laboratory personnel. 11. Interact with both government and client representatives. 12. Facilitate training of new QA employees in GLP requirements and TL's quality assurance processes and procedures. 13. Oversee scheduling and performance of phase audits for on-going studies to assure compliance with regulations. 14. Involvement in additional projects, as needed, such as auditing of validation documents (both software and equipment), and vendor/subcontractor inspections. 15. Other duties as assigned. Job Requirements : Education: Bachelor's degree (preferred) or associates degree with significant experience required. Thorough understanding of GLP regulations. Skills: Possess excellent interpersonal, organizational and verbal/written communication skills. Possess sound computer skills and be highly-motivated, detailed-oriented, and possess the versatility to work independently or in a team-oriented environment. Job Title: 105231 QA Specialist Location: West Trenton, NJ Status: Full Time Job Category: Clinical Trials Requisition Number: 105231

Job Title: Senior QA Associate I/II-Compliance Company: Dendreon Corporation Location: Morris Plains, NJ Description: Dendreon is seeking a highly motivated Senior QA Associate I/II - Compliance in our New Jersey Quality Assurance department . This is an alternate shift working the hours of 3:00 pm - 1:00 am and is eligible for shift differential. This is an excellent opportunity for someone to participate in the development and implementation of QA policies and procedures. Dendreon is a fast-paced high volume production environment with high quality and regulatory standards. Efficiency, accuracy and excellent communication skills are essential to success in this position. General Summary: Provides support in one or more of the following:Review and approval of change controls.Investigation and recall of non-conforming materials.Investigations associated with product failures, product complaints and Biological Product Deviation Reports.Material Review Board.Performs GMP internal and external audits, regulatory inspections, and monitors compliance.Reviews and approves GMP controlled documents including SOPs.Assists with tracking and trending of Quality systems including deviations, non-conformances, and CAPAs.Assembles and monitors compliance of monthly metrics and prepares other data requested by QA management.Facilitates document control and change control.Participates in the development and generation of the Annual Product Review.Provides leadership and direction to QA Associates as required. Job Requirements: Bachelor’s degree in a scientific or engineering discipline or equivalent.Typically a minimum of 5 years related experience in cGMP/FDA regulated industry.Knowledge of cGMP/QSR and FDA device/drug/biologics regulations.Proficient in MS Office applications.Experience with ERP and/or MRP systems preferred. Working Conditions and Physical Requirements: Ability to gown aseptically for work in Clean Room environments.Will be required to work alternate shifts.Some travel may be required. The preceding job description has been designated to indicate the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required for company business needs from time to time.

Job Title: 11111 Sr.QA Specialist Company: Lab Corp Location: West Trenton, NJ Description: Assuring compliance through the performance of project, process-based and facility inspections; auditing of bioanalytical and immunoanalytical data and technical reports; provide training to technical and professional staff in GLP regulations; serve as a resource on regulatory issues and GXP compliance; and participate in outside agency or sponsor-related inspections or inquiries as required. The major duties and responsibilities of the Senior Quality Assurance Specialist (NJ) include the following: 1. Possess a sound background in GLP compliance and a general knowledge of GCP compliance. 2. Familiar with all aspects of FDA and other applicable international regulations. 3. Responsible for conducting and reporting audits and inspections of facilities, projects, reports. 4. Audit support operations to assess compliance with FDA GLP regulations and industry standards. 5. Interpret complex and evolving regulatory requirements and intent. 6. Resolve regulatory compliance issues and provide regulatory support to the Laboratory. 7. Understand required document database management and archiving methods. 8. Assist in the continued development and guidance of administration programs to promote and monitor the quality and performance of operations as they relate to both pre-clinical and clinical projects. 9. Assess overall compliance with protocols, SOPs, company policies, and applicable regulations. 10. Maintain proficiency on regulatory compliance issues and provide required training to laboratory personnel. 11. Interact with both government and client representatives. 12. Facilitate training of new QA employees in GLP requirements and TL’s quality assurance processes and procedures. 13. Oversee scheduling and performance of phase audits for on-going studies to assure compliance with regulations. 14. Involvement in additional projects, as needed, such as auditing of validation documents (both software and equipment), and vendor/subcontractor inspections. 15. Other duties as assigned.

Job Title: Senior QA Associate I/II-Trainin Company: Dendreon Corporation Location: New Brunswick, NJ Description: Senior QA Associate I/II-TrainingJob Type: Regular Full-TimeLocation: Morris Plains, NJJob Description:We are seeking a skilled Associate to support the training program for Dendreon's NJ Immunotherapy Manufacturing Facility in Morris Plains, NJ. In this position, you will be responsible for ensuring compliance to corporate training requirements and assisting in the creation and maintenance of specific training plans related to drug manufacturing. The successful candidate will have the chance to be a part of ground-up implementation of the NJ site training strategy.General Summary:* Supports the implementation of Dendreon's training programs for all departments.* Trainers will be responsible for facilitating classroom training and helping to create e-learning sessions with lesson plans to train all levels of employees.* Works with all levels of management to identify training needs and perform gap analyses to implement training curricula.* Maintains electronic training record systems.* Provides support in the communication and implementation of corporate initiatives.* Supports other Corporate Training Dept. initiatives.* Ensures that all site employees are in compliance with cGMPs and SOPs.* Monitors training records of all concerned employees for cGMP compliance.* Puts together Lessons Learned from inspection audits.Job Requirements:* Bachelor's degree in a scientific discipline or equivalent.* Typically 5 years related experience in cGMP/FDA regulated industry.* Two to three years stand up training experience, facilitating courses.* Knowledge of cGMP/QSR and FDA device/drug/biologics regulations.* Proficient in MS Office Applications.* Working knowledge of clean room environments.* Working knowledge of current industry practices in training.* Experience with Articulate and Camtasia preferred.Working Conditions and Physical Requirements:* Travel up to 10%.* Lift up to 25 lbs.The preceding job description has been designated to indicate the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required for company business needs from time to time.

Job Title: Quality Assurance Technician (QA) - 3rd Shift Company: Akorn, Inc. Location: Somerset, NJ Description: The CompanyWe are an innovative $75 million, NASDAQ listed, ophthalmic and parenterals manufacturer. In anticipation of long-term, substantial growth, we offer challenging, attractive career opportunities along with competitive salaries and comprehensive benefits. Akorn is an Equal Opportunity Employer. M/F/V/D.The OpportunityWe are looking for a QA Technician to work from the hours of 9:30 PM to 6:00 AM in our Somerset, NJ facility.The qualified candidate must be able to perform the inspection of incoming packaging and labeling components, raw material sampling, line clearance and in-process inspection of drug product, cleaning validation sampling and other various QA responsibilities.Job QualificationsA degree in relevant field and class 100 cleanroom experience is required. One to two years of related experience in pharmaceutical industry is required. Contact Information Please respond in strictest confidence. To apply for this position, please visit us online at:   https://home.eease.com/recruit/?id=485360  Principals only.  No phone calls please.

Job Title: Sr. QA Associate I/II-Training Company: Dendreon Corporation Location: Morris Plains, NJ Description: We are seeking a skilled Associate to support the training program for Dendreon’s NJ Immunotherapy Manufacturing Facility in Morris Plains, NJ. In this position, you will be responsible for ensuring compliance to corporate training requirements and assisting in the creation and maintenance of specific training plans related to drug manufacturing. The successful candidate will have the chance to be a part of ground-up implementation of the NJ site training strategy. General Summary: Supports the implementation of Dendreon’s training programs for all departments. Trainers will be responsible for facilitating classroom training and helping to create e-learning sessions with lesson plans to train all levels of employees. Works with all levels of management to identify training needs and perform gap analyses to implement training curricula. Maintains electronic training record systems. Provides support in the communication and implementation of corporate initiatives. Supports other Corporate Training Dept. initiatives. Ensures that all site employees are in compliance with cGMPs and SOPs. Monitors training records of all concerned employees for cGMP compliance. Puts together Lessons Learned from inspection audits. Job Requirements: Bachelor’s degree in a scientific discipline or equivalent. Typically 5 years related experience in cGMP/FDA regulated industry. Two to three years stand up training experience, facilitating courses. Knowledge of cGMP/QSR and FDA device/drug/biologics regulations. Proficient in MS Office Applications. Working knowledge of clean room environments. Working knowledge of current industry practices in training. Experience with Articulate and Camtasia preferred. Working Conditions and Physical Requirements: Travel up to 10%. Lift up to 25 lbs. The preceding job description has been designated to indicate the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required for company business needs from time to time.

Job Title: Senior QA Associate I/II-Complia Company: Dendreon Corporation Location: New Brunswick, NJ Description: Senior QA Associate I/II-ComplianceJob Type: Full-Time 3 p.m. - 1 a.m.Location: Morris Plains, NJJob Description:Dendreon is seeking a highly motivated Senior QA Associate I/II - Compliance in our New Jersey Quality Assurance department . This is an alternate shift working the hours of 3:00 pm - 1:00 am and is eligible for shift differential. This is an excellent opportunity for someone to participate in the development and implementation of QA policies and procedures. Dendreon is a fast-paced high volume production environment with high quality and regulatory standards. Efficiency, accuracy and excellent communication skills are essential to success in this position.General Summary:* Provides support in one or more of the following:* Review and approval of change controls.* Investigation and recall of non-conforming materials.* Investigations associated with product failures, product complaints and Biological Product Deviation Reports.* Material Review Board.* Performs GMP internal and external audits, regulatory inspections, and monitors compliance.* Reviews and approves GMP controlled documents including SOPs.* Assists with tracking and trending of Quality systems including deviations, non-conformances, and CAPAs.* Assembles and monitors compliance of monthly metrics and prepares other data requested by QA management.* Facilitates document control and change control.* Participates in the development and generation of the Annual Product Review.* Provides leadership and direction to QA Associates as required.Job Requirements:* Bachelor's degree in a scientific or engineering discipline or equivalent.* Typically a minimum of 5 years related experience in cGMP/FDA regulated industry.* Knowledge of cGMP/QSR and FDA device/drug/biologics regulations.* Proficient in MS Office applications.* Experience with ERP and/or MRP systems preferred.Working Conditions and Physical Requirements:* Ability to gown aseptically for work in Clean Room environments.* Will be required to work alternate shifts.* Some travel may be required.The preceding job description has been designated to indicate the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required for company business needs from time to time.

Job Title: QA Associate I/II - Alternate Shift Company: Dendreon Corporation Location: Morris Plains, NJ Description: Dendreon is seeking top notch QA Associates for our QA department at our New Jersey Immunotherapy Manufacturing Facility. These positions will work hours from 2:30 pm - 12:30 am. The Associates will assist in the implementation of QA policies and procedures in support of clinical and commercial manufacturing. The Associates will also provide direct support to New Jersey Manufacturing, Supply Operations and Quality Control as described below. General Summary: Performs batch record preparation, issuance and batch record review.Issuance of controlled labels and forms.Performs batch record closure and product disposition.Reviews and approves GMP controlled documents including SOPs, batch records and test methods.Ensures full GMP compliance for the disposition of raw materials and components.Reviews, approves and tracks closure of deviations, non-conformances, OOS and corrective actions.Provides support for the investigation and recall of non-conforming materials.Provides support for investigations associated with product failures, product complaints and BPDRs. Requirements: Bachelor's degree in a scientific discipline or equivalent.Typically 1-2 years related experience in cGMP/FDA regulated industry.Knowledge of cGMP/QSR and FDA device/drug/biologics regulations is required.Proficient in MS Office applications.Experience with ERP and/or MRP systems preferred. Working Conditions and Physical Requirements: Extensive use of laboratory equipment, chemicals and biological materials.May require ability to gown aseptically for work in Clean Room environments.May be required to work alternate shifts. The preceding job description has been designated to indicate the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required for company business needs from time to time.

Job Title: Senior QA Associate I/II-Training Company: Dendreon Corporation Location: Morris Plains, NJ Description: We are seeking a skilled Associate to support the training program for Dendreon’s NJ Immunotherapy Manufacturing Facility in Morris Plains, NJ. In this position, you will be responsible for ensuring compliance to corporate training requirements and assisting in the creation and maintenance of specific training plans related to drug manufacturing. The successful candidate will have the chance to be a part of ground-up implementation of the NJ site training strategy. General Summary: Supports the implementation of Dendreon’s training programs for all departments. Trainers will be responsible for facilitating classroom training and helping to create e-learning sessions with lesson plans to train all levels of employees. Works with all levels of management to identify training needs and perform gap analyses to implement training curricula. Maintains electronic training record systems. Provides support in the communication and implementation of corporate initiatives. Supports other Corporate Training Dept. initiatives. Ensures that all site employees are in compliance with cGMPs and SOPs. Monitors training records of all concerned employees for cGMP compliance. Puts together Lessons Learned from inspection audits. Job Requirements: Bachelor’s degree in a scientific discipline or equivalent. Typically 5 years related experience in cGMP/FDA regulated industry. Two to three years stand up training experience, facilitating courses. Knowledge of cGMP/QSR and FDA device/drug/biologics regulations. Proficient in MS Office Applications. Working knowledge of clean room environments. Working knowledge of current industry practices in training. Experience with Articulate and Camtasia preferred. Working Conditions and Physical Requirements: Travel up to 10%. Lift up to 25 lbs. The preceding job description has been designated to indicate the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required for company business needs from time to time.