Sr. Quality Assurance Specialist, Lot Disposition
4 weeks ago
Adaptimmune is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel immunotherapy products for people with cancer. The Company's unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell platform enables the engineering of T-cells to target and destroy cancer across multiple solid tumors.Our company culture is rooted in trust, inclusion, our capacity to collaborate, and our commitment to being honest and brave in our desire to successfully transform the lives of people with cancer.The Sr. Quality Assurance Specialist will be responsible for supporting quality functions such as line clearance, batch record review, label issuance, raw material release and facilitating timely release of production lots. The successful candidate will work closely with other Quality groups, Quality Control and Manufacturing to identify strategies, tactics and objectives for product quality and GMP compliance.Key ResponsibilitiesConducts record review of executed batch records, QC testing data, and associated batch file documentation to ensure timely disposition of patient lots. Performs line/room clearance to support manufacturing activities in aseptic suitesPrint and issuance production labels, QC labels and final product labelsReview and release raw materials and consumables for GMP useQualifications & ExperienceBachelor's Degree in a scientific discipline.Minimum of 5 years in a global biopharmaceutical or biological manufacturing environment with exposure to Quality GMP operations.Direct experience with review and approval of batch records and QC testing dataKnowledge of aseptic processing and aseptic gowning techniquesBroad knowledge of GMP, ICH and FDA/EMA regulationsBroad knowledge of Quality Systems, such as Change Control, Investigations, and CAPAAbility to identify and implement continuous improvement projects as relating to Quality Assurance Operations and the Quality Management SystemDemonstrate knowledge of an ability to apply cGMP and quality system regulationsAbility and desire to effectively work in an interdisciplinary team environment and to effectively interact at multiple levels within the company to support internal manufacturing capabilitiesDesirable Demonstrated knowledge of document control systems, preferably electronic systemsAbility to work on assigned projects independently with limited supervisionAt Adaptimmune we embrace diversity and equality of opportunity. We believe that the more inclusive we are, the better our work will be. We welcome applications to join our team from all qualified candidates, regardless of age, colour, disability, marital status, national origin, race, religion, gender, sexual orientation, gender identity, veteran status or other legally protected category. It is our intent that all qualified applicants will receive equal consideration for employment.
-
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...
-
Sr. Quality Control Specialist
2 weeks ago
Philadelphia, United States Planet Pharma Full time606454Our client, a leading Pharmaceutical company in Philadelphia, PA, is looking for a Sr. Quality Control Specialist to be responsible for the review of the executed test methods and raw data for lot releaseRequired Skills:Bachelor’s degree in a relevant discipline (biological sciences or equivalent)Minimum 5 years of experience in the biopharmaceutical...
-
Sr. Quality Control Specialist
2 weeks ago
Philadelphia, United States Planet Pharma Full time606454Our client, a leading Pharmaceutical company in Philadelphia, PA, is looking for a Sr. Quality Control Specialist to be responsible for the review of the executed test methods and raw data for lot releaseRequired Skills:Bachelor’s degree in a relevant discipline (biological sciences or equivalent)Minimum 5 years of experience in the biopharmaceutical...
-
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 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**: -...
-
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...
-
Sr Quality Engineer
14 hours ago
Philadelphia, United States Planet Pharma Full timeSr Quality Engineer Needs to be a strong QA Engineer who has experience with Quality Assurance related computer system implementation - needs to have worked in a cGMP/GMP/GxP environment. Fully onsite in PA location Need to be positive, a team player, and someone technically strong Overview The Senior Quality Engineer, Quality Assurance Engineering will...
-
Sr Quality Engineer
1 day ago
Philadelphia, United States Planet Pharma Full timeSr Quality EngineerNeeds to be a strong QA Engineer who has experience with Quality Assurance related computer system implementation - needs to have worked in a cGMP/GMP/GxP environment. Fully onsite in PA locationNeed to be positive, a team player, and someone technically strongOverviewThe Senior Quality Engineer, Quality Assurance Engineering will provide...
-
Sr Quality Engineer
1 day ago
Philadelphia, United States Planet Pharma Full timeSr Quality EngineerNeeds to be a strong QA Engineer who has experience with Quality Assurance related computer system implementation - needs to have worked in a cGMP/GMP/GxP environment. Fully onsite in PA locationNeed to be positive, a team player, and someone technically strongOverviewThe Senior Quality Engineer, Quality Assurance Engineering will provide...
-
Sr Quality Engineer
2 days ago
Philadelphia, United States Planet Pharma Full timeSr Quality EngineerNeeds to be a strong QA Engineer who has experience with Quality Assurance related computer system implementation - needs to have worked in a cGMP/GMP/GxP environment. Fully onsite in PA locationNeed to be positive, a team player, and someone technically strongOverviewThe Senior Quality Engineer, Quality Assurance Engineering will provide...
-
Sr. Regulatory Specialist
1 week ago
Philadelphia, United States ZP Group Full timePiper Companies is currently looking for an experienced Sr. Regulatory Specialist (IND Submissions) in Philadelphia, Pennsylvania (PA) to work for an innovative and growing biologic oncology pharmaceutical company. The Sr. Regulatory Specialist will play an integral part in the regulatory IND submission process of new pharmaceutical...
-
Sr. Regulatory Specialist
2 days ago
Philadelphia, United States ZP Group Full timePiper Companies is currently looking for an experienced Sr. Regulatory Specialist (IND Submissions) in Philadelphia, Pennsylvania (PA) to work for an innovative and growing biologic oncology pharmaceutical company. The Sr. Regulatory Specialist will play an integral part in the regulatory IND submission process of new pharmaceutical products.Responsibilities...
-
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...
-
Philadelphia, United States Holy Redeemer Health System Full timeFull-Time 12265 Townsend Road Clerical/Administrative Support Day SR. ACCOUNTS RECEIVABLE SPECIALIST SUMMARY OF JOB: The Sr. A/R Specialist - Medicare is responsible for the claim submission and collection of all outstanding Medicare accounts. Responsible for performing resolution oriented patient collections to achieve cash recovery and A/R resolution...
-
Sr. Regulatory Operations Specialist
1 week ago
Philadelphia, PA, US Piper Companies Full timePiper Companies is currently seeking a Sr. Regulatory Operations Specialist to support a growing and innovative cell and gene therapy company in Philadelphia, PA (Hybrid Schedule). Responsibilities for the Sr. Regulatory Operations Specialist · Coordinate diverse regulatory submissions by collaborating with internal teams and stakeholders,...
-
Sr. Accounts Receivable Specialist, Healthcare
4 weeks ago
Philadelphia, United States Redeemer Health Full timeSR. ACCOUNTS RECEIVABLE SPECIALIST SUMMARY OF JOB: The Sr. A/R Specialist – Medicare is responsible for the claim submission and collection of all outstanding Medicare accounts. Responsible for performing resolution oriented patient collections to achieve cash recovery and A/R resolution goals of assigned receivables through established methods...
-
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