Quality Specialist

FEFA LLC has an immediate need for a full-time, Quality Assurance Specialist (QAS) for one of our Federal Government contracts in Silver Spring, MD.  The position is 100% on site at White Oak.

Position Summary:

• Analyze incoming documents and reports for completeness and compliance with the customer's guidelines and take appropriate steps to capture the pertinent information into databases and IT systems.
• Perform accurate and timely data entry using multiple screens in customer's system and classify/index/assign the records appropriately.
• Maintain paper and electronic records in accordance with customer's established guidelines.
• Perform document entry services, data analysis, tracking services, and stakeholder/user support
• Handle phone calls and emails from internal and external stakeholders and the public
• Perform data quality assurance (QA) and quality control (QC)...

Manufacturing QMS Specialist who will be responsible for writing and reviewing deviations, change controls, investigation reports, batch records, SOPs, CAPA etc. This position requires technical expertise in upstream and downstream process of biologics (Cytokines, monoclonal antibodies manufacturing).

Responsibilities:

• Responsible to support manufacturing team with all kinds of documentation.
• Documentation includes reviewing executed batch records (both Upstream department and Downstream batch record).
• Responsible for filing change controls, deviation, CAPA for manufacturing department.
• For all critical / major investigation, will have to use investigation tools like 5why or 6M method.
• Attend daily meetings with both upstream and downstream process to get all the documentation requirement for the day.
• Meet weekly with QA to avoid any delay in the QMS closure.
• Author batch records, SOPs and...

This position involves managing key documentation processes within a dynamic manufacturing operations team in Piscataway, NJ. The role requires expertise in upstream and downstream biologics manufacturing processes, including cytokines and monoclonal antibody production. Responsibilities include creating, reviewing, and maintaining critical documentation to support compliance and operational excellence in a biopharmaceutical environment.

Responsibilities:

• Provide comprehensive documentation support, including reviewing executed batch records for both upstream and downstream processes.
• Prepare and manage change controls, deviations, and CAPAs for manufacturing operations.
• Utilize investigation tools (e.g., 5 Whys, 6M methods) for critical or major investigations.
• Attend daily meetings with process teams to identify and address documentation needs.
• Collaborate with QA to ensure timely closure of QMS-related...

Apply Today and Join our Team!

Indoor Air Quality Specialist

Are you in school for HVAC or recently completed this program? Are you looking

to get your foot in the door with a top-tier company and begin your career?

Capital Heating & Cooling is looking for individuals with a strong work ethic,

willingness to learn, and the desire to grow within our trade. We offer paid on the

job training and significant growth potential within the company. Qualified

candidates will have clean driving record, pass a drug screen and the ability to

use basic tools.

Requirements

Capital Heating & Cooling is a leading employer in the Milwaukee area and looking

to add an Experienced HVAC...

Creative Quality Control Specialist

Job Summary

Ensuring the quality and accuracy of creative and digital medical communications deliverables. Including, but not limited to, proofreading, and comparison with templates, style and formatting guidelines, and editorial, medical, and client comments.

Essential Duties & Responsibilities

• Highly detailed review of print and digital deliverables for quality assurance and accuracy of editorial, medical, and client comment incorporation
• Ensuring adherence to format and style guides, stipulated templates, publication, congress, and pharmaceutical & biotech guidelines
• Ensuring consistency across suites of related deliverables
• Identifying errors introduced during draft development
• Suggesting modifications to improve caliber
• Marking corrections within creative platforms
• Upholding high creative...

This position involves managing key documentation processes within a dynamic manufacturing operations team in Piscataway, NJ. The role requires expertise in upstream and downstream biologics manufacturing processes, including cytokines and monoclonal antibody production. Responsibilities include creating, reviewing, and maintaining critical documentation to support compliance and operational excellence in a biopharmaceutical environment.

Responsibilities:

• Provide comprehensive documentation support, including reviewing executed batch records for both upstream and downstream processes.
• Prepare and manage change controls, deviations, and CAPAs for manufacturing operations.
• Utilize investigation tools (e.g., 5 Whys, 6M methods) for critical or major investigations.
• Attend daily meetings with process teams to identify and address documentation needs.
• Collaborate with QA to ensure timely closure of QMS-related...

Azzur Cleanrooms on Demand™      

As you look to start your journey on the next cure that can heal patients and save lives, lack of space to manufacture and properly follow cGMP processes can be a major hurdle. To address the unique needs of start-ups in your position, Azzur Cleanrooms on Demand™ is here to support production for early-phase partners, helping you accelerate your time to market. Truly unique to the industry, our on-demand cleanrooms as a service include cGMP-compliant cleanroom space, warehousing, and materials management. This allows partners to execute manufacturing activities without the need for facility ownership or reliance on contract manufacturing organizations (CMOs). Unlike working with a CMO, Azzur Cleanrooms on Demand™ mitigates risk, affording you full access and control to your IP, space, and activities. This is all backed by quality management consultants with decades of experience implementing...

Quality Assurance and Document Compliance Specialist

80K Plus Benefits

Work Onsite 5 Days A Week

Great Neck, NY

Wholesale Food and Beverage Company is seeking a skilled FSQA Compliance Specialist, with experience evaluating document compliance of supply vendors. This position will work within the Food Safety and Quality Assurance Department, in the East Coast Headquarters, with an opportunity to become a leading member of an expanding team.

Responsibilities:

Review, assess, and evaluate the compliance status of both incumbent and new suppliers (knowledge of domestic and import processes is a plus).

Manage a high volume of audit reports from vendors with multiple subsidiaries and facilities requiring additional assessments.

Ensuring compliance with Importer of Record documentation.

Oversee Foreign Supplier Verification (FSVP)...

Apply Today and Join our Team!

Indoor Air Quality Specialist

Are you in school for HVAC or recently completed this program? Are you looking

to get your foot in the door with a top-tier company and begin your career?

Capital Heating & Cooling is looking for individuals with a strong work ethic,

willingness to learn, and the desire to grow within our trade. We offer paid on the

job training and significant growth potential within the company. Qualified

candidates will have clean driving record, pass a drug screen and the ability to

use basic tools.

Requirements

Capital Heating & Cooling is a leading employer in the Milwaukee area and looking

to add an Experienced HVAC...

Express Employment is seeking a reliable and detail-oriented Part Time Quality Control Specialist to join a great team in Toledo. In this role, you will be responsible for conducting inspections and testing of products to ensure they meet quality standards and specifications.

Responsibilities

• Conduct inspections of incoming materials and finished products to ensure compliance with quality standards
• Perform routine testing and measurements to assess product quality
• Document inspection results and report any non-conformities to management
• Assist in developing and implementing quality control procedures and protocols
• Collaborate with production teams to address quality issues and implement corrective actions
• Maintain a clean and organized work area

Requirements

• High school diploma or equivalent; relevant experience preferred
• Strong attention to detail and...

CSBio is a peptide contract manufacturing founded in 1993. Our initial products were a complete line of automated synthesizers for manufacturing and process development, with a focus on cGMP production. In 1994, we opened our custom peptide facility and began producing high quality compounds for research organizations and pharmaceutical companies worldwide. In 2004, we opened our peptide production facility in Menlo Park, CA and in 2014, we expanded our production capability through the addition of a new, state of the art building dedicated to cGMP peptide production. In 2017, we passed a FDA inspection and were recommended to be approved for commercial drug substance manufacturing. In 2023, we added additional cGMP clinical production capacity in Milpitas, CA.

Job Duties:

• Review/approve Master and Executed BPRs, OOS, deviations, CAPAs, SOPs, analytical test methods, and other operation documents
• Authors or approves procedures, work...

Apply Today and Join our Team!

Indoor Air Quality Specialist

Are you in school for HVAC or recently completed this program? Are you looking

to get your foot in the door with a top-tier company and begin your career?

Capital Heating & Cooling is looking for individuals with a strong work ethic,

willingness to learn, and the desire to grow within our trade. We offer paid on the

job training and significant growth potential within the company. Qualified

candidates will have clean driving record, pass a drug screen and the ability to

use basic tools.

Requirements

Capital Heating & Cooling is a leading employer in the Milwaukee area and looking

to add an Experienced HVAC...

Gulf Coast Underground LLC is seeking a dedicated and detail-oriented Quality Control Entry Specialist to join our dynamic team. In this role, you will play a crucial part in ensuring that our products meet the highest standards of quality and compliance. As our Quality Control Entry Specialist, you will be responsible for reviewing and entering quality data into our systems, assisting in the development and implementation of quality assurance processes, and generating accurate reports that aid in decision-making. This position requires a strong eye for detail and the ability to work effectively in a fast-paced environment. Additionally, you will collaborate closely with other departments to address any quality-related issues and support continuous improvement initiatives. If you have a passion for quality and a commitment to excellence, this is an exciting opportunity to contribute to the success of Gulf Coast Underground LLC and help us maintain our reputation for high-quality...

Under the supervision of the Vice President of Quality & Compliance and the Director of Quality Improvement, coordinates the creation and review of all billing related Life Plan/Staff Action Plan documentation and provides ongoing support, training, and internal auditing to all assigned programs. Ensures that all program documents are created and received in accordance with regulatory timeframes

Role Responsibilities:

• Responsible for training assigned programs new Quality and Compliance initiatives and projects.
• Provide management with support and training on new documentation requirements as well as Medisked and Life Plan/Staff Action Plans training for new AM or AD staff.
• Acts as an additional liaison to the Care Coordination Agency and PHP staff.
• Coordinates and attends regular meetings with CCOs to support management and address issues as needed.
• Maintains and makes necessary changes to management procedures and...

The Quality Specialist should be an experienced Construction or Engineering Professional who is able to review our projects to verify they meet all necessary requirements before they are turned over to the client. The Quality Specialist will be responsible for performing scheduled audits and random spot inspections of the work in progress, the final/finished product and project quality document control to verify these items have been completed in compliance with all applicable codes, standards, plans and specifications, and meets customer requirements and expectations. The Quality Specialist should be thorough and observant with an eye for detail.

The Quality Specialist must fully understand the requirements for the product (project), and/or be willing to perform self-exploration of project documents, codes, standards and other research to learn the requirements, and have a sense of responsibility towards our reputation in the industry. The primary goal of the...

HR Allen is seeking a dedicated and detail-oriented Quality Assurance Specialist to join our dynamic team. In this pivotal role, you will be responsible for ensuring that our products and services meet the highest quality standards before they reach our clients. You will implement and maintain quality assurance processes and procedures, facilitate testing across various stages of development, and collaborate closely with cross-functional teams to provide quality feedback and improvements. The successful candidate will have a keen eye for detail, a methodical approach to problem-solving, and a commitment to excellence. You'll have the opportunity to drive quality initiatives, conduct audits, and assist in the continuous improvement of our services. If you are passionate about maintaining high standards and want to contribute to the success of HR Allen, we invite you to apply!

Responsibilities

• Develop, implement, and maintain quality assurance standards and...

CES NeoSilica is seeking a skilled Quality Assurance Specialist to join our team and uphold high-quality standards in our silica solutions. This role involves developing quality assurance protocols, conducting process inspections, and identifying improvement opportunities. We're looking for a proactive, detail-oriented individual who can thrive in a fast-paced environment and is passionate about quality and industry compliance. Collaborate with production and engineering teams to foster continuous improvement and ensure product excellence. Join us at CES NeoSilica to be part of a dedicated team focused on quality and innovation.

Requirements

• Bachelor's degree in Quality Assurance, Engineering, or a related field.
• Minimum of 3 years of experience in a quality assurance role, preferably in a manufacturing environment.
• Strong knowledge of quality control methodologies and relevant industry standards.
• Proficiency in...

Are you a detail-oriented perfectionist who loves to break things? Do you like to think about how to make good things even better? Do you believe that a user's experience on a website is as important as accomplishing their intent? Join our Product Team as a Software Quality Assurance Specialist, where you will work closely and collaborate with software engineers and visual designers in order to QA for excellent function, form, and interaction.

Key Responsibilities:

• Conduct in-depth quality assurance testing on complex software products, ensuring alignment with technical standards and user expectations.
• Test software in various technical environments that replicate user bases, ensuring compatibility and performance across platforms.
• Develop, execute, and refine advanced test plans, leveraging technical tools to improve the QA process and identify potential issues.
• Author automated tests to enable reliable...

Apply Today and Join our Team!

Indoor Air Quality Specialist

Are you in school for HVAC or recently completed this program? Are you looking

to get your foot in the door with a top-tier company and begin your career?

Capital Heating & Cooling is looking for individuals with a strong work ethic,

willingness to learn, and the desire to grow within our trade. We offer paid on the

job training and significant growth potential within the company. Qualified

candidates will have clean driving record, pass a drug screen and the ability to

use basic tools.

Requirements

Capital Heating & Cooling is a leading employer in the Milwaukee area and looking

to add an Experienced HVAC...

Pharma Industry Update: A Manufacturing QMS Specialist position is available in South Plainfield, NJ.

Position Overview:

The Manufacturing QMS Specialist will play a critical role in ensuring smooth and compliant manufacturing operations by managing essential documentation processes. The position requires hands-on expertise in both Upstream (USP) and Downstream (DSP) biologics manufacturing processes, including cytokine and monoclonal antibody production.

Key Responsibilities:

• Act as the main support for the manufacturing team regarding all documentation needs.
• Review and manage executed batch records for upstream and downstream processes.
• File and oversee change controls, deviations, and CAPAs for the manufacturing department.
...

Cambridge Isotope Laboratories, Inc. (CIL) is searching for a Quality Control Documentation Specialist, based onsite in our Tewksbury, MA facility.  CIL is the global leading company in a highly technical, extremely fast-growing industry and is a critical supplier to several scientific and high technology markets.  CIL's growing customer base spans academia, pharmaceutical, medical diagnostic and semiconductor industries enabling collaborations with Nobel laureates, industry-leading scientists, and chemists. CIL partners with leading instrument manufacturers as well pioneering research groups that have expertise in product development and drive market growth. CIL is a subsidiary of the Otsuka Pharmaceutical Group and has had consistent growth for over 40 years.

The Quality Control Documentation Specialist is responsible for performing the data review for the release of regulated and/or non-regulated materials including raw materials, in-process and finished...

Apply Today and Join our Team!

Indoor Air Quality Specialist

Are you in school for HVAC or recently completed this program? Are you looking

to get your foot in the door with a top-tier company and begin your career?

Capital Heating & Cooling is looking for individuals with a strong work ethic,

willingness to learn, and the desire to grow within our trade. We offer paid on the

job training and significant growth potential within the company. Qualified

candidates will have clean driving record, pass a drug screen and the ability to

use basic tools.

Requirements

Capital Heating & Cooling is a leading employer in the Milwaukee area and looking

to add an Experienced HVAC...

About Us:

AssistRx has engineered the perfect blend of technology and talent (you) to provide life sciences companies with an efficient solution to improve patient uptake, visibility and outcomes. Our talented team members provide therapy and healthcare system expertise to help patients achieve better results from care.

A growing organization, AssistRx views our people as our strongest asset. Join us as we continue to make a difference....

This role is responsible for leading the daily tasks associated with the company’s Patient Solutions call monitoring, scoring, and reporting as well as system data entry quality. Within this role, the Quality Assurance Specialist serves customers by identifying, analyzing, and developing improvements in productivity, quality, internal team relationships, and customer service. The Quality Assurance Specialist regularly provides support to the department managers and director to effectively maintain program...

Why work for CVRx?

CVRx pioneers' unique therapies that harness and harmonize the body’s natural systems, benefiting society and making CVRx a universal role model in healthcare. We value our commitments to others and continue to overcome challenges through determination, collaboration and purpose. If our culture and values speak to you, and if you have a passion for cutting-edge medical technologies, join our team and our mission to help others live better lives.

A day in the life:

Responsible for helping maintain the quality / documentation control system. Work with teams across the company to develop and maintain documentation to support the quality system and comply with U.S. and international regulations. Maintain and control distribution of quality systems documentation on-line. Provide quality support and solutions to internal and external customers to promote continuous process improvement. Participate as a key member of...

CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare.  

Job Type: Full time  

Job Title: Quality & Health and Safety Specialist

Location: Onsite - Atlanta Office

Role Summary : The Quality & Health and Safety Specialist is responsible for ensuring that the company’s quality management systems and health and safety programs comply with regulatory standards and internal policies....

Join Our Team as a Shipping, Etching, and Quality Specialist!

Are you detail-oriented and passionate about quality craftsmanship? We’re seeking a dedicated individual to support our Shipping, Etching, Quality, and Inventory Management teams. In this multifaceted role, you’ll ensure our products meet the highest standards while playing a vital part in our operations.

Key Responsibilities:

• Laser Etching: Accurately etch part numbers and branding onto our products, shop gauges, and tools with precision and care.
• Quality Assurance: Conduct thorough quality checks to ensure all products meet our high standards; previous quality background is a plus!
• Finishing Touches: Perform detailed finishing tasks, including polishing, deburring, and cleaning, to enhance product presentation.
• Shipping and Inventory Management: Assist with...

Azzur Group is a premier consulting firm specializing in providing innovative solutions to the life sciences industry. Our expertise in quality assurance ensures that our clients' products, processes, and systems meet the highest standards of quality and regulatory compliance. Join us and contribute to projects that enhance product safety, efficacy, and reliability while working in a dynamic and collaborative environment.

We are seeking a detail-oriented and experienced Quality Assurance Specialist to join our consulting team. The Quality Assurance Specialist will be responsible for ensuring that products and processes comply with regulatory requirements and industry standards. The ideal candidate will have a strong background in quality assurance, excellent analytical skills, and a commitment to maintaining high standards of quality and compliance.

Key Responsibilities:

• Develop, implement, and monitor quality assurance processes and procedures to ensure...

About Us:

AssistRx has engineered the perfect blend of technology and talent (you) to provide life sciences companies with an efficient solution to improve patient uptake, visibility and outcomes. Our talented team members provide therapy and healthcare system expertise to help patients achieve better results from care.

A growing organization, AssistRx views our people as our strongest asset. Join us as we continue to make a difference....

This role is responsible for leading the daily tasks associated with the company’s Patient Solutions call monitoring, scoring, and reporting as well as system data entry quality. Within this role, the Quality Assurance Specialist serves customers by identifying, analyzing, and developing improvements in productivity, quality, internal team relationships, and customer service. The Quality Assurance Specialist regularly provides support to the department managers and director to effectively maintain program...

Apply Today and Join our Team!

Indoor Air Quality Specialist

Are you in school for HVAC or recently completed this program? Are you looking

to get your foot in the door with a top-tier company and begin your career?

Capital Heating & Cooling is looking for individuals with a strong work ethic,

willingness to learn, and the desire to grow within our trade. We offer paid on the

job training and significant growth potential within the company. Qualified

candidates will have clean driving record, pass a drug screen and the ability to

use basic tools.

Requirements

Capital Heating & Cooling is a leading employer in the Milwaukee area and looking

to add an Experienced HVAC...

AWL Insurance Agency is actively seeking a meticulous and committed Quality Assurance Specialist to join our esteemed team. In this capacity, you will assume a pivotal role in ensuring that our services and customer interactions adhere to the highest quality standards. The Quality Assurance Specialist will be tasked with developing and executing quality assurance processes, performing audits of client interactions, and delivering feedback and training to team members to optimize service delivery. You will work in close collaboration with various departments to identify opportunities for improvement and to help spearhead initiatives that enhance customer satisfaction. The ideal candidate will exhibit strong analytical abilities, a sharp attention to detail, and a dedication to excellence. If you are enthusiastic about upholding high-quality standards and refining processes, we invite you to apply and become an integral member of our dynamic team at AWL Insurance...