Quality Assurance Specialist Ii
4 weeks ago
**QA Specialist II**
Be part of something altogether life-changing Working at Biomeme in the Biotechnology industry means being at the forefront of providing healthcare diagnostic technology that empowers anyone, anywhere.
**Who we are looking for**
Biomeme is seeking a QA Specialist II who will be responsible for actively supporting the development, implementation and monitoring elements of the Quality Management System. This position is responsible for managing complaint handling and provides quality oversight of production paperwork to ensure that products released meet the quality, integrity, and efficiency standards set by the organization.
**What you will do**
- Promptly and accurately review daily production paperwork and ensure manufacturing batch and device history records are complete and meet product release requirements.
- Ensure all quality records are maintained per procedures.
- Liaise with Customer Success team members in product complaint investigations leading to root cause.
- Evaluate complaints for Medical Device Reporting (MDR); prepare and submit MDR reports to FDA
- Review product complaint investigation reports based on accuracy and relevancy to the issue.
- Maintain risk management documentation post-launch and update as required per post-market surveillance/vigilance obligations.
- Facilitate meetings and escalations.
- Maintain and revise applicable processes.
- May perform QA review and approval of product labeling
- Involved in projects that drive improvements to the quality system and support individual department continuous improvement goals.
**What you bring to the table**
- B.S. degree in life sciences or related technical field
- 2-5 years professional experience in quality (or related functional area) in medical device industry
- Experience with medical devices is required
- Working knowledge of 21 CFR 820 and ISO 13485
- Ability to effectively communicate
- Excellent analytical and problem-solving skills
**It would be great if you have**
- Experience with in vitro diagnostic devices strongly preferred.
- Knowledge of problem-solving techniques (Root Cause analysis, Fault Tree analysis, 5-whys, etc.)
-
Quality Assurance Specialist
1 month ago
Philadelphia, United States Antithesis Foods Inc. Full timePosition: QA & Compliance SpecialistCompany: Antithesis Foods, Inc.Location: Philadelphia, PA Company Mission:We are a food company making processed foods healthier using the best food science. Our goal is to make eating healthier, more accessible, more affordable, and more delicious. What We Do:We develop, scale, and manufacture better-for-you processed...
-
Quality Assurance Specialist
1 month ago
Philadelphia, United States Antithesis Foods Inc. Full timePosition: QA & Compliance SpecialistCompany: Antithesis Foods, Inc.Location: Philadelphia, PA Company Mission:We are a food company making processed foods healthier using the best food science. Our goal is to make eating healthier, more accessible, more affordable, and more delicious. What We Do:We develop, scale, and manufacture better-for-you processed...
-
Quality Control Training Specialist II
3 weeks ago
Philadelphia, United States Planet Pharma Full timeOverview The Quality Control Training Specialist II is responsible for establishing a formal training program and certification requirements for all QC Teams. The Training Specialist II is responsible for developing, conducting, and revising a QC training program on the methods used in the laboratories (Flow, EM, potency assays, etc.). They are responsible...
-
Quality Control Training Specialist II
4 weeks ago
Philadelphia, United States Planet Pharma Full timeOverview The Quality Control Training Specialist II is responsible for establishing a formal training program and certification requirements for all QC Teams. The Training Specialist II is responsible for developing, conducting, and revising a QC training program on the methods used in the laboratories (Flow, EM, potency assays, etc.). They are responsible...
-
Quality Control Training Specialist II
3 weeks ago
Philadelphia, United States Planet Pharma Full timeOverview The Quality Control Training Specialist II is responsible for establishing a formal training program and certification requirements for all QC Teams. The Training Specialist II is responsible for developing, conducting, and revising a QC training program on the methods used in the laboratories (Flow, EM, potency assays, etc.). They are responsible...
-
Quality Assurance Analyst
1 month ago
Philadelphia, Pennsylvania, United States IT Excel LLC Full timeJob Description The QA analysis job description encompasses two main roles testing and documentation. After software developers complete software programming quality assurance analysts test it. They use a variety of tools testing applications and reports to compare the software to user requirements. They ensure that the software functions according to those...
-
Quality Assurance Analyst
1 month ago
Philadelphia, United States IT Excel LLC Full timeJob Description -The QA analysis job description encompasses two main roles testing and documentation. After software developers complete software programming quality assurance analysts test it. They use a variety of tools testing applications and reports to compare the software to user requirements. They ensure that the software functions according to...
-
Quality Assurance Engineer
4 weeks ago
Philadelphia, United States Derbyshire Machine & Tool Company Full timeAre you ready to take your career to the next level? Do you have a passion for ensuring precision and reliability in cutting-edge defense systems? We invite you to be a part of our dynamic team at Derbyshire Machine and Tool Company as a Quality Engineer! At Derbyshire Machine and Tool Co., we are at the forefront of innovation in defense technology. With a...
-
Quality Assurance Materials Specialist
4 days ago
Philadelphia, United States Wapt Full timeOverview: Main function is to release raw materials intended for Manufacturing and Testing Operations according to site policies and procedures. Assists in the preparation of Standard Operating Procedures (SOPs). Review and approve deviations and low-risk non-conforming events (NCEs). Lead and implement continuous improvement. **Responsibilities**: -...
-
Manager, Quality Assurance Lot Disposition
4 weeks ago
Philadelphia, United States Adaptimmune Full timeJob DescriptionJob DescriptionAdaptimmune is a fully integrated cell therapy company, designed and built from the ground up with four U.K.- and U.S.-based biotechnology hub locations. Our comprehensive capabilities and teams include preclinical research, clinical development, translational sciences, autologous and allogeneic manufacturing, and in-house...
-
Quality Assurance Oversight Representative I
2 weeks ago
Philadelphia, United States Orbis Sibro, Inc. Full timeQuality Assurance Oversight Representative I Philadelphia, PA This position is to support the Navy Surface Warfare Center Philadelphia's (NSWCPD) SUBSAFE Certification Branch (Code 242) in performing technical Quality Assurance (QA) work for the US N Quality Assurance, Assurance, Representative, Mechanical, Support, Manufacturing, Business Services, Quality
-
Quality Assurance Coordinator
2 weeks ago
Philadelphia, United States Addison Group Full timeRole : Quality Assurance Coordinator Location : Philadelphia, PA Neighborhood : Center City, PA Job Type : 37.5 hours/week, Hybrid (2-3 days in office), Contract Pay Rate: $20/hour An Addison Group client is looking for a Quality Assurance Coordinator to join their team! Job Responsibilities: Oversee the processes and protocols concerning the Adult and Youth...
-
Quality Assurance Materials Specialist
4 days ago
Philadelphia, Pennsylvania, United States Wapt Full timeOverview: Main function is to release raw materials intended for Manufacturing and Testing Operations according to site policies and procedures. Assists in the preparation of Standard Operating Procedures (SOPs). Review and approve deviations and low-risk non-conforming events (NCEs). Lead and implement continuous improvement. Responsibilities: • Reviews...
-
Student Trainee
4 weeks ago
Philadelphia, United States Defense Logistics Agency Full timeSummary VACANCY INFORMATION AND AVAILABLE CAREER FIELDS: DLA Troop Support at Philadelphia, Pennsylvania - Student Trainee (Quality Assurance) - GS-3/4 target GS-11, Multiple Full-time/Part-Time Permanent positions.
-
Quality Assurance Coordinator
2 weeks ago
Philadelphia, United States Addison Group Full timeJob DescriptionJob DescriptionRole: Quality Assurance Coordinator Location: Philadelphia, PA Neighborhood: Center City, PA Job Type: 37.5 hours/week, Hybrid (2-3 days in office), Contract Pay Rate: $20/hourAn Addison Group client is looking for a Quality Assurance Coordinator to join their team! Job Responsibilities: Oversee the processes and protocols...
-
Quality Assurance Coordinator
3 days ago
Philadelphia, United States JFK Behavioral Health Center Full timeJob Description Job Description POSITION OVERVIEW: Responsible for quality review of charts and documents under the regulatory licensing standards in order to ensure program efficacy and compliance; alternate administrator for Electronic Health Record system. Our QA Coordinator will:Select charts, uses census tracking form for monthly chart-compliance...
-
Quality Assurance Engineer
1 week ago
Philadelphia, PA, 19117, Montgomery County, PA, United States Derbyshire Machine & Tool Company Full timeAre you ready to take your career to the next level? Do you have a passion for ensuring precision and reliability in cutting-edge defense systems? We invite you to be a part of our dynamic team at Derbyshire Machine and Tool Company as a Quality Engineer! At Derbyshire Machine and Tool Co., we are at the forefront of innovation in defense technology. With a...
-
Quality Assurance Coordinator
4 weeks ago
Philadelphia, United States JFK Behavioral Health Center Full timeJob DescriptionJob DescriptionPOSITION OVERVIEW: Responsible for quality review of charts and documents under the regulatory licensing standards in order to ensure program efficacy and compliance; alternate administrator for Electronic Health Record system. Our QA Coordinator will:Select charts, uses census tracking form for monthly chart-compliance...
-
Quality Assurance Test Lead
3 days ago
Philadelphia, United States IntePros Consulting Full timeIntePros seeking an experienced NG Test Lead with a strong background in the healthcare domain. Qualified Candidate must be able to work a hybrid schedule onsite in Philadelphia, PA. Experience working specifically in critical workflows including enrollment, benefits, billing, and claims (both local and ITS). The ideal candidate will possess excellent...
-
Quality Systems Specialist Ii
1 month ago
Philadelphia, United States Iovance Biotherapeutics Inc Full time**Overview** **Essential Functions and Responsibilities** - Maintain the electronic Quality Management System (eQMS), with emphasis on Deviation, CAPA, and Change Control processes - Provide user support to the eQMS system users - Run reports and conduct data analysis to support tracking of change controls, deviations, and CAPAs to ensure timely closures of...