UNKNOWN

FEED

Ensure that components, containers, closures, in-process materials, packaging materials, labeling, and finished dosage forms are examined and approved or rejected to ensure that all these meet their current specifications. Maintain oversight of the QA program and Quality Management System (QMS) at a single SOFIE manufacturing facility producing products under both 21 CFR Part 212 and 211 (as needed) regulations.

SOFIE is motivated by Innovation. Passion. Collective genius. Hard work. We believe in nurturing great ideas and great people. From our Board to our Team, we&rsquo;re dedicated to bringing a new vision of theranostics and innovative technologies to healthcare. With our acquisition of Zevacor Pharma, Inc in 2017, we have become SOFIE, a combined company of radiopharmacies, contract manufacturing services, radiosynthesizers, and pre-clinical imaging systems. We are especially excited about the possibilities before us in 2018, as we&rsquo;ll be offering new products and an expanded network to support our belief in life-changing Theranostics, and continue to lead the way in quality, service, and innovation. Together, we&rsquo;re on a mission to improve patient lives, from start to clinic. If you want to join us in our mission, visit our careers page and help us change the world We offer a competitive salary, a comprehensive benefits package, and advancement opportunity. SOFIE is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or other characteristic protected by law.

SOFIE

Quality Assurance Specialist (QAS) I

ADAPTED_NOW

The role works closely with site and global teams to ensure compliant documentation practices, effective records management, archival governance, and sustained inspection readiness. Under the oversight of the Quality Assurance Leadership, this position is responsible for providing quality and operational oversight of Document Control, Records Retention, and Archive Management activities.

HOUR

Every day, System One focuses on services and solutions that require a high degree of specialization, in-demand technical skills, and large-scale operational expertise. We are essential partners to those on the front lines of our nation’s most critical infrastructure, technology, and life sciences initiatives. 
Founded more than 40 years ago as a staffing partner to the engineering industry, today System One is a diversified organization operating in over 50 locations and putting more than 9,000 people to work in the United States, Canada, and the United Kingdom.

System One

Document Control Specialist, QA

PERMANENT

FULL_TIME

POSTING_API

Experience, Education and Qualifications: Bachelor of Science in chemical, biological, or clinical laboratory science or medical technology from an accredited institution - OR -Associate of Science in a laboratory science, or medical laboratory technology from an accredited institution - OR -Equivalent education of 60 semester hours with 24 semester hours in biological and chemical science courses. The AP-QST is the primary resource to assist department management, QST, and/or department staff with navigating the Issue Review and CAPA modules in MasterControl, as well as assisting department staff with training on the processes and various ways of identifying IRs.

Staff Icons

Quality Specialist Technologist Anatomic Pathology

TEMPORARY

CONTRACTOR

The ideal candidate will have experience in omnichannel campaign management, content governance within MLR environments, vendor management, and enterprise platform operations and a proven ability to deliver compliant, on-time, and on-budget campaigns at scale . The role operates as a strategic and operational partner to Brand and Omnichannel Strategy teams, owning the end-to-end development, review, production, and deployment of digital and print marketing assets across a portfolio of brands.

TSR Consulting

Digital Marketing Specialist

YEAR

The Quality Assurance and Regulatory Affairs Lead is responsible for assisting the Quality Assurance team with day-to-day activities in support of companywide quality assurance procedures. The right candidate will have excellent written/verbal communication skills, strong attention to detail, and work well in fast paced environment.

Canfield Imaging Systems is the world-leading developer of specialized photographic systems for medical practices, institutions, research organizations, and pharmaceutical suppliers. Canfield offers comprehensive benefits to its eligible full-time employees. These include paid days off, medical, dental, and vision insurance, may be eligible for a discretionary bonus, and a 401(k) plan with employer match (currently set at 50%). The anticipated salary range for the position is $. This is dependent upon consideration of multiple factors when determining a base salary such as a candidate’s experience, education, and current market conditions. If the role is eligible for full benefits, it will be discussed with you during the interview process. Canfield Imaging Systems is a division of Canfield Scientific, Inc., the largest provider of photographic documentation systems and services for pharmaceutical research.

Canfield Scientific, Inc.

Quality Assurance and Regulatory Affairs Lead

The right candidate will have some experience with regulatory processes, possess strong interpersonal skills, be very detail oriented, organized, and work well independently while being part of a larger team. We are seeking a Quality Assurance Administrative Assistant who will be responsible for supporting our quality assurance team onsite in our Parsippany, NJ office.

PAID_TIME_OFF

401K_MATCH

401K

MEDICAL_DENTAL_VISION

Canfield Imaging Systems is the world-leading developer of specialized photographic systems for medical practices, institutions, research organizations, and pharmaceutical suppliers. Canfield offers comprehensive benefits to its eligible full-time employees. These include paid days off, medical, dental, and vision insurance, may be eligible for a discretionary bonus, and a 401(k) plan with employer match (currently set at 50%). The anticipated salary range for the position is $22.00-$26.00 per hour. This is dependent upon consideration of multiple factors when determining a base salary such as a candidate’s experience, education, and current market conditions. If the role is eligible for full benefits, it will be discussed with you during the interview process. Canfield Imaging Systems is a division of Canfield Scientific, Inc., the largest provider of photographic documentation systems and services for pharmaceutical research.

Quality Assurance Administrative Assistant

The QC/QA Manager builds, runs and improves the quality systems that keep product consistent for customers, meet regulatory requirements, and keep our certifications (ISO 9001, NSF, UL and other third-party programs) in good standing. Information collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal.

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Jobot

Quality Manager

They are looking to add a Quality Engineer to their team who will focus on the following duties: ensuring that the company’s products conform to all specifications and customer requirements, directing/overseeing activities associated with maintaining all company certifications, overseeing configuration management, and quality assurance processes, and serving as the interface with customers and vendors on quality related topics. Information collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal.

Quality Engineer

This role will oversee ISO 9001, customer quality, internal and external audits, supplier quality, corrective and preventive actions, product certifications, quality documentation, calibration programs, and continuous improvement initiatives. Information collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal.

QC/QA Manager – Plastics Manufacturing

This role utilizes lived experience to assist clients in building connections to community resources, developing long-term recovery supports, and maintaining engagement throughout the treatment continuum. Pyramid Healthcare offers comprehensive behavioral healthcare defined by supportive environments that offer patients the strength they need to overcome life’s challenges.

Pyramid Healthcare

Certified Peer Recovery Specialist (CPRS)

A contract development and manufacturing organization that specializes in producing topical, semi-solid, and liquid pharmaceutical products for both prescription and over-the-counter markets. * Develop and execute validation protocols (IQ/OQ/PQ) for clean utilities, autoclaves, isolators, sterilizers (VHP & steam), laboratory instruments, fillers, and controlled temperature units.

Synerfac Technical Staffing

Senior Validation Specialist

2) assessing the needs of the SOFIE network, implementing training, assisting in developing plans, and facilitating a variety of training initiatives and programs that enhance the effectiveness of the SOFIE workforce. The Training Specialist supports quality, manufacturing, and operational initiatives for the SOFIE network by (1) assisting in developing, facilitating, and supervising training programs for employees.

Training Specialist I

We are seeking an experienced CADD Specialist to provide Computer-Aided Design and Drafting (CADD), Building Information Modeling (BIM), engineering documentation, and geospatial support to the U.S. Army Reserve 99th Readiness Division (RD), Directorate of Public Works (DPW). The employee must be able to perform the essential functions of the position, with or without reasonable accommodation, including prolonged computer work, reviewing large-format engineering drawings and plans, accessing project and facility locations as required, and occasionally handling plans, files, and related materials.

Q&A Diversified LLC

CADD Specialist

Lead receipt and inspection of pharmaceutical products for compliance with Good Documentation Practices (GDP), Drug Supply Chain Security Act (DSCSA), and regulatory requirements. System One, and its subsidiaries including Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America.

Senior Quality Assurance Associate

Day to Day/Responsibilities : Draft and format internal communications related to benefits, wellness programs, and healthcare education to ensure employees are informed of initiatives and resources. The Benefits Specialist will support internal communication strategies, help organize wellness initiatives, and maintain quality and structure in benefits-related documentation and systems.

Computer Enterprises Inc

Benefits Specialist

Lead and coordinate end-to-end technology transfer projects for drug substance and/or drug product between R&D, manufacturing sites, and external partners (CMOs/CDMOs) including review of all technical documentation (gap assessments, comparability protocols, equipment qualification, and validation protocols/reports.). Lead the Quality Assurance activities for sterile pharmaceutical products manufactured by third-party manufacturers including change controls, product quality incidents, deviations, non-conformances, out of specification/out of trend investigations, product complaints and CAPAs.

QA Product Manager (Sterile Products)

Information collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal. The company specializes in a comprehensive range of logistics solutions, including domestic and international freight forwarding, truck and rail brokerage, customs services, warehousing, order fulfillment, and inventory management.

Import Specialist

Nice to have: direct experience with ChemStewards or a comparable EHS&S system (Responsible Care®, RC14001); experience in dispersion, emulsion, or polymer manufacturing; prior work at a growing or newly acquired manufacturer where systems were being built, not inherited. You'll spend time in production areas requiring PPE (safety glasses, footwear, gloves, and periodic respiratory protection), and should be comfortable standing/walking for extended periods, climbing stairs and ladders, and occasionally lifting up to 50 lbs.

EHS, QMS & Regulatory Specialist

Information collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal. With a customer-first approach and a culture built on collaboration, innovation, and problem-solving, the organization helps businesses navigate complex supply chains with speed, agility, and confidence.

Export Specialist

The RCM Product Specialist will lead the development, implementation, and validation of manufacturing and analytical methods of new diagnostic and therapeutic radiopharmaceuticals for SOFIE within the itheranostic / FAPI Division. Working closely with SOFIE’s pharmaceutical partners and internal staff, they will ensure that these radiopharmaceuticals are in full compliance with all regulatory requirements (specifically, 21 CFR 211and 212).

Qa Specialist Jobs in New Jersey

Quality Assurance Specialist (QAS) I SOFIE

Document Control Specialist, QA System One

Quality Specialist Technologist Anatomic Pathology Staff Icons

Digital Marketing Specialist TSR Consulting

Quality Assurance and Regulatory Affairs Lead Canfield Scientific, Inc.

Quality Assurance Administrative Assistant Canfield Scientific, Inc.

Quality Manager Jobot

Quality Engineer Jobot

QC/QA Manager – Plastics Manufacturing Jobot

Certified Peer Recovery Specialist (CPRS) Pyramid Healthcare

Senior Validation Specialist Synerfac Technical Staffing

Training Specialist I SOFIE

CADD Specialist Q&A Diversified LLC

Senior Quality Assurance Associate System One

Benefits Specialist Computer Enterprises Inc

QA Product Manager (Sterile Products) System One

Import Specialist Jobot

EHS, QMS & Regulatory Specialist Synerfac Technical Staffing

Export Specialist Jobot

RCM Product Specialist SOFIE

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