Current jobs related to Senior Quality Assurance Specialist - New Albany, Ohio - Amplifybio, LLC
-
Quality Assurance Specialist
2 weeks ago
New Albany, Ohio, United States Alene Candles Midwest LLC Full timeJob SummaryWe are seeking a Quality Assurance Specialist to join our team at Alene Candles Midwest LLC. As a Quality Assurance Specialist, you will be responsible for monitoring and reporting on the quality of candle components, in-process candle production, and finished candles at pack-out. You will also be responsible for monitoring and reporting on candle...
-
Quality Assurance Specialist
2 weeks ago
New Albany, Ohio, United States Wedgewood Village Pharmacy, LLC Full timeQuality Assurance RoleAt Wedgewood Village Pharmacy, LLC, we are seeking a Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our pharmaceutical products. This includes performing quality activities in a sterile pharmaceutical manufacturing facility, understanding...
-
Senior Quality Assurance Compliance Specialist
2 weeks ago
New Albany, Ohio, United States AmplifyBio Full timeAbout the RoleAmplifyBio is seeking a highly skilled Senior Quality Assurance Compliance Specialist to join our team in New Albany, OH. As a key member of our Quality Assurance team, you will be responsible for managing and executing the Supplier Quality Management (SQM) and Audit Programs for our GMP facility.This role requires a strong understanding of GMP...
-
Senior Quality Assurance Compliance Specialist
3 weeks ago
New Albany, Ohio, United States AmplifyBio Full timeAbout AmplifyBioAmplifyBio is a leading contract research organization that provides a comprehensive range of services, including discovery stage R&D work, preclinical CRO services, and manufacturing services for cell, gene, and mRNA-based therapeutics.Job SummaryWe are seeking a Senior Quality Assurance Compliance Specialist to join our growing team at...
-
Senior Quality Assurance Manager
5 days ago
Albany, Ohio, United States EPM Scientific Full timeJob Summary:We are seeking an experienced Senior Quality Assurance Manager to lead QA and QC activities for our new site. This role will involve reviewing and approving quality documentation, creating annual product reviews, and providing assistance during regulatory inspections.Key Responsibilities:Review and approve quality documentation, including batch...
-
New Albany, Ohio, United States American Regent, Inc. Full timeJob SummaryThis role is part of the Quality Assurance team at American Regent, Inc. The QA Contract Manufacturing Organization Specialist is responsible for ensuring the quality of pharmaceutical products manufactured by third-party contractors. The Specialist will review batch records, ensure compliance with cGMPs and company SOPs, and collaborate with...
-
Quality Assurance Specialist
2 weeks ago
New London, Ohio, United States Synerfac Full timeJob Title: Quality Assurance SpecialistJob Summary:Our client, a leading Tier 1 supplier to Honda, is seeking a skilled Quality Assurance Specialist to join their team. With over 40 years of experience in the electronic components industry, they are committed to delivering high-quality products.Key Responsibilities:* Investigate and analyze quality problems...
-
New Albany, Ohio, United States American Regent, Inc. Full timeJob Summary:The QA Contract Manufacturing Organization Specialist is a critical member of the Quality Assurance team at American Regent, Inc. This role is responsible for ensuring the quality of pharmaceutical products manufactured by third-party contract manufacturers.Key Responsibilities:Provide quality assurance review of batch records to ensure...
-
Quality Assurance Specialist
2 weeks ago
New Carlisle, Ohio, United States PFI Precision Full timeAbout the Role:PFI Precision is seeking a skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products by collecting and selecting samples of machined parts for inspection.Key Responsibilities:Collect and select samples of machined parts for inspection.Read...
-
Quality Assurance Specialist
2 weeks ago
New Albany, Ohio, United States Alene Candles Full timeJob SummaryThe Quality Assurance Technician is responsible for reviewing and validating incoming raw materials, components, and standards to ensure compliance with quality standards. This role involves investigating and resolving quality-related issues, as well as processing samples for burn testing and fulfilling customer requirements.This position requires...
-
Quality Assurance Specialist
2 weeks ago
New Carlisle, Ohio, United States Staffmark Group Full timeJob Summary: We are seeking a Quality Assurance Specialist to join our team at Staffmark Group. As a Quality Assurance Specialist, you will be responsible for ensuring that manufactured parts and components meet established quality standards and customer specifications.Key Responsibilities:Conduct inspections of machined parts using precision tools...
-
Data Center Quality Assurance Specialist
2 weeks ago
New Albany, Ohio, United States Inova Health System Full timeJob Summary: We are seeking a highly skilled Quality Assurance Professional to join our team at Inova Health System. As a Technical Support Engineer for Data Center Operations, you will be responsible for ensuring the quality and reliability of our data center equipment. Key Responsibilities: Conduct thorough inspections of electronic parts and components...
-
Quality Assurance Specialist
4 weeks ago
New Albany, Ohio, United States Alene Candles Midwest LLC Full timeJob OverviewAlene Candles Midwest LLC is seeking a highly skilled Quality Technician to join our team. As a Quality Technician, you will play a critical role in ensuring the quality of our products and maintaining a safe work environment.Key ResponsibilitiesSupport the supervisor with quality-related items in a manufacturing process environment.Monitor and...
-
Quality Assurance Manager
3 weeks ago
New Albany, Ohio, United States AmplifyBio Full timeAbout the RoleWe are seeking a highly skilled and experienced Quality Assurance Manager to join our team at AmplifyBio. As a key member of our quality team, you will be responsible for ensuring the quality and compliance of our products and services.Key ResponsibilitiesDevelop and implement quality management systems and procedures to ensure compliance with...
-
Quality Assurance Coordinator
4 weeks ago
New Albany, Ohio, United States Pharmavite Full timeQuality Assurance CoordinatorPharmavite is seeking a Quality Assurance Coordinator to join our team. As a Quality Assurance Coordinator, you will play a critical role in ensuring the consistent quality of our manufacturing processes.Responsibilities:Assemble and review all manufacturing or packaging documents, processing steps, and laboratory test records to...
-
Quality Assurance Coordinator
3 weeks ago
New Albany, Ohio, United States Pharmavite LLC Full timeQuality Assurance CoordinatorPharmavite LLC is seeking a highly skilled Quality Assurance Coordinator to join our team. As a key member of our quality team, you will be responsible for ensuring the consistent quality of all manufacturing processes by tracking, reviewing, and evaluating all documents and records accompanying our manufacturing or packaging...
-
Quality Assurance Line Inspector
3 weeks ago
New Albany, Ohio, United States Bright Innovation Labs Full timeJob Title: Quality Assurance Line InspectorAt Bright Innovation Labs, we are seeking a highly skilled Quality Assurance Line Inspector to join our team. As a Quality Assurance Line Inspector, you will be responsible for ensuring that our production processes meet the highest standards of quality and safety.Key Responsibilities:Inspect and sample products to...
-
Quality Assurance Manager
1 month ago
New Albany, Ohio, United States AmplifyBio Full timeAbout the RoleWe are seeking a highly skilled Quality Assurance Manager - Supplier Quality to join our team at AmplifyBio. As a key member of our Quality Assurance department, you will be responsible for ensuring the quality and compliance of our suppliers and raw materials.Key ResponsibilitiesDevelop and implement procedures for supplier qualification, raw...
-
Quality Assurance Manager
3 weeks ago
New Albany, Ohio, United States AmplifyBio Full timeAbout the RoleAmplifyBio is seeking a highly skilled Quality Assurance Manager - Supplier Quality to join our team in New Albany, OH. As a key member of our Quality Assurance team, you will be responsible for the management and execution of the Supplier Quality Management (SQM) and Audit Programs for our GMP facility.The ideal candidate will have a strong...
-
Quality Assurance Manager
3 weeks ago
Albany, Ohio, United States Wedgewood Village Pharmacy, LLC Full timeQuality Manager Job DescriptionAt Wedgewood Village Pharmacy, LLC, we are seeking a highly skilled Quality Manager to join our team. As a Quality Manager, you will be responsible for managing quality assurance and quality control processes and teams at our Albany 503b manufacturing facility.Key Responsibilities:Manage quality assurance and quality control...
Senior Quality Assurance Specialist
2 months ago
We are seeking a highly skilled Senior QA Compliance Specialist to join our team at AmplifyBio, LLC. As a key member of our Quality Management team, you will be responsible for ensuring the execution of our Quality Management System for our New Albany GMP facility.
Key Responsibilities- Implement and manage systems for Quality Management, Quality Assurance, Data stewardship, and governance.
- Maintain complaint and nonconformance processing through records and tracking systems, including FMEA, root-cause analysis and corrective actions.
- Participate in drafting quality assurance agreements as required.
- Analyze operational and delivery processes, and ensure that they comply with company standards, industry regulations, state/federal laws, and best practices.
- Ensure product and facility compliance with AmplifyBio policies and procedures, US and Global Quality System Regulations including, but not limited to 21CFR11, 21CFR210, 21CFR211, and EudraLex Volume 4 Annex 1.
- Identify and investigate gaps in process, policy, procedures and First Line of Defense controls.
- Support completion of analysis, identify issues and provide recommendations for compliance process improvements both internally and with clients.
- Develop and report on KPIs / metrics for the Quality Management System to identify areas for improvement.
- Provides site training on investigation tools.
- Manage deviation, CAPA and Change Control review boards.
- A bachelor's degree or higher in a relevant scientific discipline or equivalent education and experience.
- A minimum 5+ years of experience within the Quality Unit in a GMP pharmaceutical environment.
- Must have experience with deviation and CAPA management, ASQ Certified Pharmaceutical GMP Professional a strong plus.
- Experience enforcing GMP regulation and guidelines related to the conduct of early phase clinical programs through commercial manufacturing.
- Ability to work with minimal supervision.
- Strong interpersonal skills, ability to work in a team environment, attention to details and excellent problem resolutions skills.
- Ability to apply a risk-based approach related to this role.
AmplifyBio, LLC is a leading contract research organization with a comprehensive range of services that span from being an outsourcing partner for discovery stage R&D work, a preclinical CRO performing safety efficacy and toxicology studies for small molecules and advanced therapies alike, and, most recently, an expansion into manufacturing services for cell, gene, and mRNA-based therapeutics.
Why Work with Us- Competitive Compensation Package.
- Health, Dental, and Vision insurance that starts on your first day at AmplifyBio.
- UNLIMITED PTO policy.
- Generous paid parental leave.
- Wellness and Self-Care Programs.
- 401(k) match.
- Tuition Reimbursement.
- EAP/work-life support system.
- A fun work environment where everyone's voice matters.
