Quality Control Specialist II, Sterility Assurance
6 hours ago
We are seeking a highly skilled Quality Control Specialist II, Sterility Assurance to join our team at Planet Pharma. This role will be responsible for ensuring the harmonized execution of contamination control policies across our manufacturing sites.
Key Responsibilities:- Collaborate with stakeholders to develop and implement sterility assurance principles and contamination control strategies.
- Support site compliance with global microbial control standards and procedures.
- Design and implement contamination control strategies and risk assessments.
- Develop and maintain microbial contamination and cross-contamination risk assessments.
- Perform environmental monitoring and utility trending reports.
- Support the development of new product introductions and process designs.
- Qualify laboratory equipment for microbiological testing.
- Align and harmonize global microbiological and aseptic standards, policies, and procedures.
- Participate in facility design and modification, cleaning, and sanitization programs.
- Participate in inspections and troubleshoot contamination-related issues.
- Bachelor's degree in a relevant discipline (biological sciences or equivalent).
- Minimum three (3) years of experience in the pharmaceutical industry within a Quality Control microbiology role.
- Knowledge and familiarity with cGMP/ICH/FDA/EU Annex 1 compliance regulations and USP, EP, and JP monographs for microbiology.
- Knowledge of microbiological and sterility testing, media fills, environmental monitoring, microbiology methods (endotoxin, mycoplasma, and sterility).
- Experience with microbiological risk assessments.
- Excellent analytical, written, and verbal communication skills.
- Ability to manage multiple priorities and work in a fast-paced environment.
- Advanced degree preferred.
- Experience with cell therapy products is a plus.
We offer a competitive salary and benefits package. If you are a motivated and detail-oriented individual with a passion for quality control, we encourage you to apply.
-
Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full timeJob DescriptionJob Summary:The Quality Control Specialist, Sterility Assurance will be responsible for ensuring the harmonized execution of contamination control policies across two manufacturing sites in Philadelphia. This role will also support new product transfers related to contamination control aspects of manufacturing process and equipment design,...
-
Sterility Assurance Specialist I
4 weeks ago
Philadelphia, Pennsylvania, United States WuXi AppTec Full timeJob SummaryWe are seeking a highly skilled Sterility Assurance Specialist I to join our team at WuXi AppTec. The successful candidate will be responsible for ensuring the quality and integrity of our products by implementing and maintaining sterility assurance programs.Key ResponsibilitiesDevelop and implement environmental monitoring performance...
-
Sterility Assurance Specialist
1 week ago
Philadelphia, Pennsylvania, United States WuXi AppTec Full timeJob SummaryWe are seeking a highly skilled Sterility Assurance Specialist to join our team at WuXi AppTec. As a key member of our quality assurance team, you will be responsible for ensuring the sterility and quality of our products.Key ResponsibilitiesDevelop and implement sterility assurance programs to ensure compliance with regulatory...
-
Sterility Assurance Specialist
4 weeks ago
Philadelphia, Pennsylvania, United States WuXi AppTec Full timeJob SummaryWe are seeking a highly skilled Sterility Assurance Specialist to join our team at WuXi AppTec. As a key member of our Sterility Assurance department, you will be responsible for ensuring the highest standards of contamination control and sterility assurance in our manufacturing operations.Key ResponsibilitiesDevelop and implement sterility...
-
Sterility Assurance Specialist
2 days ago
Philadelphia, Pennsylvania, United States WuXi AppTec Full timeJob SummaryWe are seeking a highly skilled Sterility Assurance Specialist to join our team at WuXi AppTec. As a key member of our Data Operations department, you will be responsible for ensuring the highest standards of sterility assurance in our manufacturing operations.Key ResponsibilitiesDevelop and implement sterility assurance programs, including...
-
Sterility Assurance Specialist I
4 weeks ago
Philadelphia, Pennsylvania, United States WuXi AppTec Full timeJob SummaryWuXi AppTec is seeking a highly skilled Sterility Assurance Specialist I to join our team. As a Sterility Assurance Specialist I, you will be responsible for ensuring the sterility of our products and processes.Key ResponsibilitiesDevelop and implement sterility assurance programs to ensure the quality and safety of our products.Conduct aseptic...
-
Sterility Assurance Specialist I
3 weeks ago
Philadelphia, Pennsylvania, United States WuXi AppTec Full timeJob SummaryWe are seeking a highly skilled Sterility Assurance Specialist I to join our team at WuXi AppTec. As a key member of our Sterility Assurance department, you will be responsible for ensuring the highest standards of contamination control and sterility assurance in our manufacturing operations.Key ResponsibilitiesDevelop and implement sterility...
-
Sterility Assurance Specialist
3 weeks ago
Philadelphia, Pennsylvania, United States WuXi AppTec Full timeJob SummaryWe are seeking a highly skilled Sterility Assurance Specialist to join our team at WuXi AppTec. As a key member of our Data Operations department, you will be responsible for ensuring the highest standards of sterility assurance in our manufacturing operations.Key ResponsibilitiesDevelop and implement sterility assurance programs, including...
-
Sterility Assurance Specialist
3 weeks ago
Philadelphia, Pennsylvania, United States WuXi AppTec Full timeJob SummaryWe are seeking a highly skilled Sterility Assurance Specialist to join our team at WuXi AppTec. As a key member of our Data Operations department, you will be responsible for ensuring the highest standards of sterility assurance in our manufacturing operations.Key ResponsibilitiesDevelop and implement sterility assurance programs, including...
-
Sterility Assurance Specialist
3 weeks ago
Philadelphia, Pennsylvania, United States WuXi AppTec Full timeJob SummaryWe are seeking a highly skilled Sterility Assurance Specialist to join our team at WuXi AppTec. As a key member of our Data Operations department, you will be responsible for ensuring the highest standards of sterility assurance in our manufacturing operations.Key ResponsibilitiesDevelop and implement sterility assurance programs, including...
-
Sterility Assurance Specialist
4 weeks ago
Philadelphia, Pennsylvania, United States WuXi AppTec Full timeJob SummaryWe are seeking a highly skilled Sterility Assurance Specialist to join our team at WuXi AppTec. As a key member of our Sterility Assurance department, you will be responsible for ensuring the highest standards of contamination control and sterility assurance in our manufacturing operations.Key ResponsibilitiesAuthor and review qualifications such...
-
Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full timeJob Title: Associate Director, Quality Control, Sterility AssuranceJob SummaryIovance Biotherapeutics Inc is seeking a highly motivated Associate Director, Quality Control, Sterility Assurance to join our team. The successful candidate will be responsible for assisting in the development and oversight of microbial contamination control processes and...
-
Sterility Assurance Specialist I
4 weeks ago
Philadelphia, Pennsylvania, United States WuXi AppTec Full timeAbout the RoleWe are seeking a highly skilled Sterility Assurance Specialist I to join our team at WuXi AppTec. As a key member of our Sterility Assurance department, you will be responsible for ensuring the highest standards of sterility and contamination control in our manufacturing operations.Key ResponsibilitiesDocument Development: Author and review...
-
Quality Control Specialist II
3 weeks ago
Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full timeJob SummaryWe are seeking a highly skilled Quality Control Analyst II to support quality control testing operations at our Cell Therapy Center. The successful candidate will be responsible for performing daily cGMP quality control laboratory microbiological testing activities, environmental monitoring, and data analysis.Key ResponsibilitiesPerform daily cGMP...
-
Quality Control Analytical Specialist
1 month ago
Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full timeJob OverviewPosition Title: Analytical Sciences & Technology Specialist ISalary: CompetitiveRole Summary:The Analytical Sciences & Technology Specialist I is responsible for the technical advancement of quality assurance methodologies and processes, including the validation of methods and instruments, as well as the technical transfer related to Analytical...
-
Quality Assurance Specialist
2 weeks ago
Philadelphia, Pennsylvania, United States Meet Full timeQuality Assurance Engineering SpecialistMeet our growing Biotech client, seeking a Quality Assurance Engineering Specialist/Senior level to join their team in Philadelphia, PA.Job Summary:As a Quality Assurance Engineering Specialist in the pharmaceutical industry, you will play a critical role in ensuring the quality and compliance of our products...
-
Quality Assurance Specialist
4 weeks ago
Philadelphia, Pennsylvania, United States PCI Pharma Services Full timeJob SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at PCI Pharma Services. As a Quality Assurance Specialist, you will be responsible for ensuring the quality and compliance of our products and processes.Key ResponsibilitiesConduct regular audits and inspections to ensure compliance with regulatory requirements and...
-
Quality Control Specialist II
1 month ago
Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full timeJob SummaryWe are seeking a highly skilled Quality Control Specialist II to join our team at Iovance Biotherapeutics Inc. The successful candidate will be responsible for supporting quality control testing operations at our Cell Therapy Center.Key ResponsibilitiesPerform daily cGMP quality control laboratory microbiological testing activities, including...
-
Quality Assurance Specialist I
2 weeks ago
Philadelphia, Pennsylvania, United States WuXi AppTec Full timeJob Title: Quality Assurance Specialist IWuXi AppTec is seeking a highly skilled Quality Assurance Specialist I to join our team. As a Quality Assurance Specialist I, you will be responsible for ensuring the quality of our products and services by conducting quality control checks, investigating quality issues, and implementing corrective actions.Key...
-
Senior Quality Assurance Specialist
1 week ago
Philadelphia, Pennsylvania, United States Meet Full timeQuality Assurance Engineering SpecialistMeet our growing Biotech client, a leading pharmaceutical company seeking a Quality Assurance Engineering Specialist to join their team.Job Summary:As a Quality Assurance Engineering Specialist, you will play a critical role in ensuring the quality and compliance of our products throughout the development and...