Quality Assurance Specialist

4 weeks ago

newark, United States Planet Pharma Full time

JOB SUMMARY:

  • The Quality Assurance Specialist II is an intermediate level position with hands-on QA experience.
  • Under moderate supervision, the individual will be working primarily on quality systems, the reserve sample program, and incoming attribute inspections.
  • The individual will also assist in the quality operations area, such as batch record and quality control data review, line clearances, AQL inspection, and will interact with cross-functional groups such as Quality Control, Manufacturing, and Regulatory Affairs.

ESSENTIAL DUTIES:

  • Perform a wide variety of quality assurance activities to ensure compliance with internal procedures, applicable US and international regulatory requirements for biologic drug substances and drug products under clinical development.
  • Assist in the management of the reserve sample program.
  • Perform incoming quality attribute inspections.
  • Review, approve, and track closure of the change controls, deviations, quality investigations, and CAPAs.
  • Prepare quality system metrics.
  • Review and disposition of incoming raw materials.
  • May support quality operations as needed (e.g., review executed records such as batch records/quality control data or equipment qualifications; perform line clearance and product inspection; review other records under supervision such as change control requests, deviations, lab investigations, environmental monitoring excursions, proposed CAPAs).
  • Support continuous improvement of quality systems. Author new, revise existing department procedures and/or forms.
  • Assist in internal compliance audits as needed.
  • Provide inspection readiness support and assist during inspections by regulatory authorities or other third parties.
  • Other duties as assigned.

WORK ENVIRONMENT and PHYSICAL DEMANDS:

  • This section of the job description is required by the American with Disability Act (ADA).
  • The ADA requires that job descriptions reflect the physical and mental demands required to effectively perform the essential duties of the job.
  • The ADA prohibits employers from discriminating against a “qualified individual with a disability” in all aspects of the employment relationship.
  • A “qualified individual with a disability” is “an individual who meets the education, experience, skill, and other job-related requirements of a position held or desired, and who, with reasonable accommodation, can perform the essential functions of a specified job.”

Physical Demands:

  • Prolonged periods of sitting at a desk and working on a computer.
  • Must be able to lift up to 10 pounds at times.


EXPERIENCE:

  • Minimum 4 years of experience performing quality functions in pharmaceutical and/or biotech-related fields.
  • Some working knowledge of quality systems cGMP standards applicable to clinical biologics DS and DP.
  • Works under moderate supervision.
  • Ability to independently analyze and reconcile simple issues.
  • Ability to organize and manage multiple tasks in a fast-paced environment, with minimal instruction on routine work and moderate instruction on new assignments.
  • Good verbal and written communication and interpersonal skills.

PREFERRED ADDITIONAL SKILLS (I.E., COMPUTER):

  • Proficient with commonly used word processing, database systems, and other software.

Education:

  • BS or equivalent in biology, chemistry, or related science or equivalent experience.

  • Quality Assurance Specialist

    4 weeks ago

    Newark, Delaware, United States Hologic Full time

    Quality Assurance SpecialistAt Hologic, we are seeking a highly skilled Quality Assurance Specialist to join our team in Newark, DE. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our medical devices and ensuring compliance with regulatory requirements.Key Responsibilities: Process and evaluate product returns for our...

  • Quality Assurance Specialist

    4 weeks ago

    Newark, Delaware, United States ViaSat Full time

    About ViasatViasat is a leading provider of global communication services, and we're seeking a Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products and services.Key ResponsibilitiesPerform thorough inspections of products to ensure they meet our quality...

  • Quality Assurance Specialist

    4 weeks ago

    Newark, New Jersey, United States Meet Full time

    Job Title: Quality Assurance SpecialistDepartment: Quality AssuranceCategory: Quality and RegulatoryJob Summary:We are seeking a Quality Assurance Specialist to support our client's innovative biotechnology company. This position offers hands-on experience in quality systems, reserve sample programs, and incoming attribute inspections. You'll work...

  • Quality Assurance Specialist

    4 weeks ago

    newark, United States Meet Full time

    Job Title: Quality Assurance Specialist IIDepartment: Quality AssuranceCategory: Quality and RegulatoryJob Summary:We are seeking a Quality Assurance Specialist II to join our client's innovative biotechnology company. This intermediate-level position offers hands-on experience in quality systems, reserve sample programs, and incoming attribute inspections....

  • Quality Assurance Specialist

    4 weeks ago

    newark, United States Meet Full time

    Job Title: Quality Assurance Specialist IIDepartment: Quality AssuranceCategory: Quality and RegulatoryJob Summary:We are seeking a Quality Assurance Specialist II to join our client's innovative biotechnology company. This intermediate-level position offers hands-on experience in quality systems, reserve sample programs, and incoming attribute inspections....

  • Quality Assurance Specialist

    4 weeks ago

    Newark, United States Meet Full time

    Job Title: Quality Assurance Specialist IIDepartment: Quality AssuranceCategory: Quality and RegulatoryJob Summary:We are seeking a Quality Assurance Specialist II to join our client's innovative biotechnology company. This intermediate-level position offers hands-on experience in quality systems, reserve sample programs, and incoming attribute inspections....

  • Quality Assurance Specialist

    4 weeks ago

    Newark, Delaware, United States Seven Seven Software Full time

    Quality Assurance SpecialistAt Seven Seven Software, we are seeking a Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for designing, writing, and executing automated test scripts using Selenium & Cucumber for API Automation.Maintaining and enhancing existing automated test scripts and frameworks to...

  • Quality Assurance Specialist II

    4 weeks ago

    newark, United States IDR, Inc. Full time

    IDR is seeking a Quality Assurance Specialist II to join one of our top clients in Newark, CA This role is a unique opportunity for a seasoned professional to take grow and develop within the Biotechnology Field. If you are looking for an opportunity to join a large organization and work within a team-oriented culture, please apply today!Position...

  • Quality Assurance Specialist II

    3 weeks ago

    newark, United States IDR, Inc. Full time

    IDR is seeking a Quality Assurance Specialist II to join one of our top clients in Newark, CA This role is a unique opportunity for a seasoned professional to take grow and develop within the Biotechnology Field. If you are looking for an opportunity to join a large organization and work within a team-oriented culture, please apply today!Position...

  • Quality Assurance Specialist II

    4 weeks ago

    Newark, United States IDR, Inc. Full time

    IDR is seeking a Quality Assurance Specialist II to join one of our top clients in Newark, CA This role is a unique opportunity for a seasoned professional to take grow and develop within the Biotechnology Field. If you are looking for an opportunity to join a large organization and work within a team-oriented culture, please apply today!Position...

  • Quality Assurance Specialist

    1 month ago

    Newark, Delaware, United States First Choice Staffing, LLC Full time

    Job DescriptionWe are seeking a highly skilled Quality Assurance Specialist to join our team at First Choice Staffing, LLC. This is a direct hire / permanent opportunity with a competitive starting salary, Time & Half for Overtime, Flexible Work Schedule, Medical Benefits, PTO/Vacation, Paid Holidays, opportunity for professional growth, and other great...

  • Senior Quality Assurance Specialist

    4 weeks ago

    Newark, California, United States IDR, Inc. Full time

    IDR, Inc. is seeking a seasoned Quality Assurance Specialist II to join our team in the Biotechnology Field. This role offers a unique opportunity for professional growth and development within a large organization.Position Overview:The Quality Assurance Specialist II will perform a wide variety of quality assurance activities to ensure compliance with...

  • Quality Assurance Specialist

    4 weeks ago

    Newark, Delaware, United States ACL Digital Full time

    We are seeking a skilled Quality Assurance Specialist to join our team at ACL Digital. Key responsibilities include:Key Skills and Experience:2+ years of experience in software QAAbility to operate and communicate effectively in a fast-paced environmentTesting experience with Linux/AndroidJira experienceTest case creation experienceExperience with automotive...

  • Quality Assurance Specialist

    4 weeks ago

    Newark, Delaware, United States ViaSat Full time

    About usViasat is a leading provider of satellite-based communications solutions. We're on a mission to deliver connections with the capacity to change the world.Our team is dedicated to shaping the future of communication, and we're looking for talented individuals to join us.As a Quality Assurance Specialist, you will be a key member of our quality...

  • Electronics Quality Assurance Specialist

    4 weeks ago

    Newark, Delaware, United States Hologic Full time

    Hologic is seeking a dedicated Electronics Quality Assurance Specialist to oversee the quality of Electronics / Metals components/subassemblies. This role requires technical knowledge across the organization to ensure quality and compliance with regulatory standards.The ideal candidate will have a Bachelor's degree in Materials/Electronic/Electric...

  • Call Center Quality Assurance Specialist

    1 week ago

    Newark, United States Adecco Full time

    Adecco is searching for a Call Center Quality Assurance Specialist for a meal subscription company in Newark, NJ. Hybrid to Newark, NJ 2-3 days a week$30/hr - weekly payThrough end of March 2025 with possibility of extensionThis is not a calling position - this will be overseeing the script, making recommendations and ideas. The Quality Assurance Specialist...

  • Senior Quality Assurance Specialist

    1 month ago

    Newark, Delaware, United States Ampcus Full time

    Job Summary:As a Senior Quality Assurance Specialist at Ampcus, you will be responsible for ensuring the quality of our products and services. This includes completing manufacturing-related testing and processes, performing complex quantitative and qualitative analysis, and interacting with other departments to ensure compliance with FDA, ISO, and IVDD...

  • Quality Assurance Specialist

    4 weeks ago

    Newark, United States Planet Pharma Full time

    JOB SUMMARY:The Quality Assurance Specialist II is an intermediate level position with hands-on QA experience.Under moderate supervision, the individual will be working primarily on quality systems, the reserve sample program, and incoming attribute inspections.The individual will also assist in the quality operations area, such as batch record and quality...

  • Quality Assurance Specialist II

    4 weeks ago

    Newark, United States TalentBurst Full time

    Quality Assurance Specialist II Newark, CA 94560 6 Months (Possible Extension) ​Duties: JOB SUMMARY: Commercial stage biotechnology company focused on innovative aesthetic, therapeutic and financial technology offerings, setting a new standard in healthcareThe Quality Assurance Specialist II is an intermediate level position with hands-on QA...

  • Quality Assurance Specialist II

    4 weeks ago

    Newark, Delaware, United States R&D Partners Full time

    Job DescriptionA commercial stage biotechnology company focused on innovative aesthetic, therapeutic and financial technology offerings, setting a new standard in healthcare, is seeking a Quality Assurance Specialist II. This is an intermediate level position with hands-on QA experience. Under moderate supervision, the individual will be working primarily on...