Senior Quality Assurance Validation Specialist
1 month ago
Primary resource for the development, execution, review, and approval of equipment/software validations (including Computerized Laboratory Systems), System Life Cycle Documentation (Validation Plans, Design Specifications, Requirements Specifications, etc.), Change Controls, Decommissioning Reports, etc., in accordance with 21 CFR Part 11 and GAMP5. Monitors equipment/software processes for adherence to established procedures/regulatory compliance. Provides guidance for equipment/software related issues and consults with QA Management to resolve complex quality issues in a timely manner.
Responsibilities:
• Cross functional Metrology and QA Representative for Equipment/Software Validations
• Write, execute, review, or approve Equipment and Software Validations (IQ, OQ, PQ).
• Write, execute, review, or approve Change Controls.
• Write, review, or approve Periodic Reviews.
• Stay current with changes to GXP, including FDA and EU and other regulatory bodies as well as guidance documents (i.e.: ICH, ISPE, GAMP, ISO, etc.).
• Interact frequently with laboratory/manufacturing/facility staff to provide expertise on equipment/software validations. Address conditions/practices with appropriate personnel, reports findings to QA Management.
• Issues, reviews, or approves document change requests.
• Perform QA inspections including, but not limited to, Internal Audits and Supplier Audits.
• Participate in quality and process improvement initiatives, and project teams.
• Coordinates area training.
• Participate as needed to support Client and Regulatory audits.
• Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
• Normally receives minimal instructions on routine work and detailed instructions on new assignments.
• Ability to work in a team environment and independently as required
Qualifications:
• 8+ years of relevant experience or equivalent
• Bachelors’ degree in a Science related field or equivalent experience
Knowledge / Skills / Abilities:
• Knowledge of 21 CFR Part 11 and ISPE GAMP5 is required.
• Knowledge of cGMP requirements, PTC guidelines and ISO17205 is highly desirable.
• Ability to accomplish the described duties through the use of appropriate computer equipment and software (Microsoft Word, Excel, Outlook, and Access).
• Ability to accurately and reproducibly perform arithmetic, algebraic and geometric calculations.
• Ability to record data accurately and legibly.
• Ability to use judgment as dictated by the complexity of the situation.
• Ability to understand and follow verbal or demonstrated instructions.
• Ability to work effectively as part of a team and to exhibit effective interpersonal skills.
• Ability to receive, comprehend and to effectively communicate detailed information through verbal and written communication
• Proficient in Oral & Written communication skills
• Need to be able to read, write and understand English
Our Values:
Integrity & Dedication, Working Together & Sharing Success; Do the Right Thing & Do it Right.
Our greatest asset is our people, WuXi is dedicated to providing opportunities for internal growth with direct access to a dedicated and accessible Human Resources team.
WuXi AppTec provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.
-
Quality Assurance Specialist
2 months 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
2 months 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
2 months 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
7 days ago
Philadelphia, United States US Defense Logistics Agency Full time**Duties**: - The following duties will be performed in a developmental capacity. - Providing pre-award and post-award support to contracting officers and engineering activities, contract administration components, and DLA contractors; - Assisting in preparing and issuing QA letters of instruction to government inspection activities/depots on contract...
-
Quality Assurance Specialist
1 month ago
Philadelphia, United States Community Integrated Services Full timeConsider joining Community Integrated Services, the region's leading supported employment provider, as we empower people with disabilities through individualized employment opportunities. Through creativity, flexibility, and community collaboration, CIS provides individualized, person-centered support and training to help individuals with disabilities attain...
-
Product Validation Specialist
6 days ago
Philadelphia, United States Ace American Insurance Full timeProduct Validation Specialist - 8373 DESCRIPTION/RESPONSIBILITIES: In this role, you will work closely with the NA Digital Consumer Team, product owners, Tech Team, and other members of the Operations group in testing, implementing, and managing products, processes, user acceptance testing and data validation to dramatically improve the customer...
-
Product Validation Specialist
23 hours ago
Philadelphia, United States Ace American Insurance Full timeProduct Validation Specialist - 8373 DESCRIPTION/RESPONSIBILITIES: In this role, you will work closely with the NA Digital Consumer Team, product owners, Tech Team, and other members of the Operations group in testing, implementing, and managing products, processes, user acceptance testing and data validation to dramatically improve the customer...
-
Manager, Quality Assurance Lot Disposition
1 week ago
Philadelphia, United States Adaptimmune Full timeAdaptimmune 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 commercial and corporate...
-
Sales Specialist
18 hours ago
Philadelphia, United States Discovery Senior Living Full timeJob DescriptionJob DescriptionAbout Discovery Senior LivingDiscovery Senior Living ranks prominently among the 5 largestsenior housing providers in the US, and is nationally renowned for designing,developing, marketing, and operating a multi-brand portfolio of upscale, luxurysenior-living communities. With over 250 communities in nearly 40states, and 15,000...
-
Quality Assurance Risk/management Specialist
2 weeks ago
Philadelphia County, PA, United States Commonwealth of PA Full time**THE POSITION**: Do you possess problem solving skills and would like a career where you can put those skills to use by helping ensure Pennsylvania Veterans and their spouses are properly cared for? The Department of Military and Veterans Affairs, Delaware Valley Veterans' Home is searching for a Quality Assurance/Risk Management Specialist. This position...
-
Manager, Quality Assurance Lot Disposition
1 month 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...
-
Manager, Quality Assurance Lot Disposition
17 hours 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...
-
Senior Sterility Assurance Specialist
24 hours ago
Philadelphia, United States R&D Partners Full timeJob DescriptionJob DescriptionEssential Functions and ResponsibilitiesChampioning sterility assurance principals at the site in the areas of aseptic processing, and contamination control.Support the site compliance to the global microbial control standards/procedures on environmental monitoring, critical utilities, contamination control strategy, clean-room...
-
Senior Sterility Assurance Specialist
1 month ago
Philadelphia, United States R&D Partners Full timeJob DescriptionJob DescriptionEssential Functions and ResponsibilitiesChampioning sterility assurance principals at the site in the areas of aseptic processing, and contamination control.Support the site compliance to the global microbial control standards/procedures on environmental monitoring, critical utilities, contamination control strategy, clean-room...
-
Senior Quality Engineer
3 weeks ago
Philadelphia, United States Planet Pharma Full time(This is a full time permanent position available for people located in the Philadelphia, PA area)OverviewThe Senior Quality Engineer, Quality Assurance Engineering will provide Quality oversight and support for the development and operations of a commercial scale cGMP cell therapy manufacturing and laboratory facility along with associated software...
-
Senior Quality Engineer
2 weeks ago
Philadelphia, United States Planet Pharma Full time(This is a full time permanent position available for people located in the Philadelphia, PA area)OverviewThe Senior Quality Engineer, Quality Assurance Engineering will provide Quality oversight and support for the development and operations of a commercial scale cGMP cell therapy manufacturing and laboratory facility along with associated software...
-
Quality Assurance Manager
1 week ago
Philadelphia, United States Joy Baking Group Full timeJob DescriptionJob DescriptionJOB SUMMARY: The Quality Assurance Manager supports the Hermitage Cookie production facility at the Hermitage, PA location to facilitate and maintain the food safety and quality programs in coordination with Production, Warehouse, Maintenance, Procurement, and Sanitation departments. This position will work closely with the...
-
Quality Assurance Specialist Ii
1 month ago
Philadelphia, United States Biomeme, Inc. Full time**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,...
-
Quality Assurance Specialist Iii
2 weeks ago
Philadelphia, United States Wapt Full timeOverview: **Responsibilities**: - Reviews and approves Non-conforming events (NCE) and CAPAs - Reviews and approves Change Controls, Document Change Requests and Technical Transfers - Conducts review of pre-executed and executed Manufacturing batch records in accordance with cGMP and internal procedures in an efficient and timely manner. Assure that...
-
Senior Quality Release Specialist
1 week ago
Philadelphia, United States Iovance Biotherapeutics Inc Full timeJob DescriptionJob DescriptionSalary: Iovance is hosting an onsite Job Fair. Where: Iovance Cell Therapy Center (iCTC) Location: 300 Rouse Blvd Philadelphia, PA 19112 Date: Monday, June 24, 2024 Time: 12pm to 6pm (EDT) What to bring: Updated resumeWe are Hiring! We look forward to seeing you at the Job Fair. OverviewThe Senior Quality...