Quality Assurance Specialist

2 weeks ago


Wilmington, Delaware, United States Alkermes Full time
Job Description

This role is responsible for supporting the daily manufacturing and facility operations. Key responsibilities include discrepancy tracking, document review, training program support, shutdown notifications, work orders, TrackWise reporting, shift communication, and CAPA tracking. The position will work with manufacturing to identify resolutions to events while collaborating with Quality Management.

Key Duties:
  • Authority to approve written procedures and other documents
  • Develop Standard Operating Procedures and other quality-related documents
  • Evaluation of batch manufacturing records and testing records
  • Follow-up on preventive and corrective actions associated with deviations, lab investigations, and Environmental Excursions
  • Interact with plant personnel to ensure CGMP compliance
  • Support manufacturing in the writing and approval of discrepancy reports
  • Provide manufacturing line support by ensuring cGMP adherence
Requirements:
  • Working knowledge of US Drug Product GMP requirements and associated guidelines
  • Experience in Pharmaceutical Quality Assurance, including the ability to identify and resolve compliance issues
  • Ability to increase others' knowledge of US and European GMP regulations and guidance
  • Strong written and oral communication skills
  • Experience in administration of quality systems for drug product manufacturing and quality control operations
Personal Attributes:
  • Team Player committed to quality; motivated self-starter; detail and results-oriented; well-organized, efficient worker with good communication skills
  • Innovative thinker and problem solver; flexible and can embrace change; can manage multiple duties and tasks
  • Ability to utilize knowledge and interpersonal skills to provide leadership, direction, and development of others
  • Good motivator of personnel; good team player with a can-do attitude
Education and Experience:
  • Requires a Bachelor's degree in a scientific discipline or equivalent
  • Minimum of 4 years' experience in a Quality Assurance role in the pharmaceutical industry


  • Wilmington, Delaware, United States Alkermes Full time

    Job SummaryWe are seeking a highly motivated and detail-oriented Quality Assurance Specialist to support our daily activities related to manufacturing operations and quality systems. This role is responsible for ensuring compliance with regulatory requirements and industry standards.Key ResponsibilitiesIssuance of GxP documentationDocument Management System...


  • Wilmington, Delaware, United States Fortive Corporation Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at Fortive Corporation. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products and processes.Key ResponsibilitiesMeasure and inspect parts and final assemblies using various gages and equipment.Complete and maintain first...


  • Wilmington, Delaware, United States L3Harris Full time

    Job Title:Space System Quality Assurance SpecialistJob Summary:L3Harris is seeking a highly skilled Quality Assurance Specialist to support the development and implementation of quality plans for space-based imaging systems. The ideal candidate will have a strong background in quality engineering and experience working in a fast-paced, dynamic...


  • Wilmington, Delaware, United States Biolog Inc Full time

    Job DescriptionBiolog Inc is seeking a highly skilled Quality Assurance Associate to join our team in Newark, DE. As a Quality Assurance Associate, you will play a critical role in ensuring the quality and integrity of our laboratory services.Responsibilities:Ensure effective quality assurance to meet customer expectations by managing time and resources...


  • Wilmington, Delaware, United States AstrixTechnology LLC Full time

    Job OverviewAstrix Technology LLC is seeking a highly skilled Quality Assurance Associate to join our team. As a Quality Assurance Associate, you will play a critical role in ensuring the quality and compliance of our products.Key ResponsibilitiesEvaluate raw material records and testing records to ensure compliance with regulatory requirements.Disposition...


  • Wilmington, Delaware, United States Source Recruitment Solutions Full time

    Quality Assurance Manager Job DescriptionWe are seeking an experienced Quality Assurance Manager to join our team at Source Recruitment Solutions. As a Quality Assurance Manager, you will be responsible for ensuring the highest quality standards are met in our food manufacturing plant.Key Responsibilities:Develop and implement quality control programs to...


  • Wilmington, Delaware, United States Source Recruitment Solutions Full time

    Quality Assurance Manager Job DescriptionWe are seeking an experienced Quality Assurance Manager to join our team at Source Recruitment Solutions. The successful candidate will be responsible for managing all aspects of quality assurance in a food manufacturing plant.Key Responsibilities:Direct a QA staff and facility, enforcing and setting company standards...


  • Wilmington, Delaware, United States Alkermes Full time

    Job Title: Quality Assurance InspectorAlkermes is seeking a Quality Assurance Inspector to join our team in a manufacturing environment. As a Quality Assurance Inspector, you will be responsible for inspecting finished products and empty containers for defects, performing daily process activities in compliance with standard operating procedures (SOPs), and...


  • Wilmington, Delaware, United States BlueSky Innovations Full time

    About BlueSky InnovationsWe are a dynamic and growing company in the pharmaceutical industry, committed to delivering high-quality products and services. Our team of experts is dedicated to ensuring the highest standards of quality and compliance.Job DescriptionWe are seeking a highly motivated Quality Assurance Employee to join our team in Friedrichsdorf....


  • Wilmington, Delaware, United States Power Home Remodeling Full time

    Director of Agile and Quality AssuranceAt Power Home Remodeling, we're seeking a seasoned professional to lead our Agile and Quality Assurance team. As the Director of Agile and Quality Assurance, you'll play a pivotal role in shaping the future of our software development initiatives and platform.About the RoleWe're looking for a strategic leader with a...


  • Wilmington, Delaware, United States ConforMIS Full time

    Job Summary:The Product Quality Engineer will be responsible for ensuring the quality of our medical devices. This includes interpreting and implementing quality standards, conducting quality testing, and performing product release activities.Key Responsibilities:Develop and maintain strong internal working relationships across Conformis.Understand the...


  • Wilmington, Delaware, United States ConforMIS Full time

    Job Summary:The Product Quality Engineer II will be responsible for ensuring the quality of our medical devices, including product quality engineering, non-conforming material report write-ups, and investigation, statistical process control, process improvements, and quality control oversight.Key Responsibilities:Develop and maintain strong internal working...


  • Wilmington, Delaware, United States ConforMIS Full time

    Job Summary:The Product Quality Engineer II will be responsible for ensuring the quality of our medical devices, including product quality engineering, non-conforming material report write-ups, and investigation, statistical process control, process improvements, and quality control oversight.Key Responsibilities:Develop and maintain strong internal working...


  • Wilmington, Delaware, United States Alkermes Full time

    Job DescriptionAlkermes is seeking a highly motivated and experienced individual for the position of Senior Quality Assurance Associate, at the Wilmington, OH location. Responsibilities include supporting daily compliance and systems activities. Performs customer complaints investigations approval, writes Annual Product Reviews (APRs), and performs internal...


  • Wilmington, Delaware, United States Millstone Medical Full time

    Become a pivotal part of Millstone Medical Testing, a dynamic organization dedicated to excellence and employee development.Millstone Medical Outsourcing is a rapidly expanding medical service provider, specializing in top-tier Orthopedic solutions. Our Testing division, renowned for over 30 years of proficiency in microbiological laboratory testing,...


  • Wilmington, Delaware, United States BlueSky Innovations Full time

    We are a leading pharmaceutical company, BlueSky Innovations, operating in the future-proof industry. Our company has been successful and on a growth path since 2002.We are a highly motivated team of around 260 employees who work together to tackle the future.We are looking for a Quality Assurance Employee with a focus on computer validation to join our...


  • Wilmington, Delaware, United States Alkermes Full time

    Job DescriptionAlkermes is seeking a highly motivated and experienced individual for the position of Senior Quality Assurance Associate, at the Wilmington, OH location. Responsibilities include supporting daily compliance and systems activities. Performs customer complaints investigations approval, writes Annual Product Reviews (APRs), and performs internal...


  • Wilmington, Delaware, United States Ferno-Washington, Inc Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Inspector to join our team at Ferno-Washington, Inc. As a Quality Assurance Inspector, you will be responsible for inspecting final products and components at various stages of the production process.Key ResponsibilitiesInspect raw materials, parts, components, and finished products for compliance...


  • Wilmington, Delaware, United States Michael Holm and Associates Full time

    Job DescriptionMichael Holm and Associates is seeking an experienced Senior Quality Assurance Manager to join our team.Job Summary:We are looking for a highly skilled and experienced Quality Assurance Manager to oversee the quality and safety of our sanitation services. The ideal candidate will have a strong background in quality assurance, safety protocols,...


  • Wilmington, Delaware, United States Alkermes Full time

    Job DescriptionAlkermes is seeking a highly motivated and experienced individual for the position of Senior Quality Assurance Associate, at the Wilmington, OH location. Responsibilities include supporting daily compliance and systems activities. Performs customer complaints investigations approval, writes Annual Product Reviews (APRs), and performs internal...