Senior Quality Assurance Specialist

4 weeks ago

Athens, Georgia, United States J&J Family of Companies Full time
Senior Quality Assurance Specialist

We are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Janssen Pharmaceuticals, Inc., a member of the J&J Family of Companies. This role will be based in Athens, GA, and will play a critical part in ensuring the quality and safety of our pharmaceutical products.

Key Responsibilities:

  • Review and assess batch records for completeness, accuracy, and adherence to GMP regulations, specifications, and company Standard Operating Procedures (SOPs).
  • Maintain accurate and complete documentation of all batch record review activities.
  • Provide timely disposition to manufactured products in the ERP system based on the result of testing and compliance with all requirements.
  • Prepare Certificate of Analysis for finished products.
  • Oversee controls and standards for Nonconformance, CAPAs, and Change Control.
  • Contribute to continuous improvement efforts by identifying opportunities to enhance batch record accuracy and efficiency.
  • Coordinate and participate in plant weekly meetings for Shop Floor Control to discuss batch record status, including discrepancies and/or issues that may impact batch release.
  • Draft, review, revise, approve, and authorize procedures, work instructions, protocols, validations, specifications, and qualifications within the controlled document system.
  • Partner with internal production planning to ensure awareness and alignment with production planning and delivery schedules.

Qualifications:

  • A Bachelor's degree or University equivalent in Engineering or a related scientific, planning, or business field is required.

Experience and Skills:

  • A minimum of three (3) years of related work experience in a GMP pharmaceutical or medical device manufacturing environment is required.
  • Organized, diligent, and able to multi-task and prioritize responsibilities.
  • Collaboration and influence leadership skills to partner effectively across functions and operating units.
  • Excellent communication skills, able to inspire trust and build credibility.
  • Must have skills to perform tasks without continuous supervision but seeking input as needed.
  • Strong problem-solving (RCA/RCPS) skills to assist with defining problems, collection of data, establishment of facts, and drawing valid conclusions.

Preferred Qualifications:

  • Knowledge of ICH Guidelines and US FDA 21 CFR 210 and 211.
  • Experience with SAP or other ERP system.
  • Working knowledge of Microsoft Office software programs. Ability to effectively use software applications for data entry, data analysis, word processing, presentations, and calculations.
  • Understand Quality Systems regulation requirements for pharmaceuticals and medical devices.
  • Able to lead multiple initiatives daily while being flexible and adaptable to shifting priorities when needed.
  • Ability to apply risk management philosophy to business processes, decisions, and data.

Additional Information:

  • This position is in Athens, GA, and may require up to 10% domestic or international travel.
  • This position requires 100% of the work on-site in support of Manufacturing.
  • Must be willing to work beyond traditional hours to support needs of business partners on a scheduled or emergency basis.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career, and life journey, please visit .

Primary Location NA-US-Georgia-Athens

Organization Janssen Pharmaceuticals, Inc

Travel Yes, 10 % of the Time

Job Function Quality Assurance

Req ID: W

  • Senior Quality Assurance Specialist

    1 month ago

    Athens, Georgia, United States J&J Family of Companies Full time

    Job SummaryWe are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Janssen Pharmaceuticals, Inc., a member of the J&J Family of Companies. This role will be located in Athens, GA, and will support the manufacture of safe, effective Medical Device Components.Key Responsibilities:Review and assess batch records for completeness,...

  • Quality Assurance Specialist

    18 hours ago

    Athens, Georgia, United States American Refining Group Full time

    Job Title: Quality Assurance SpecialistAt American Refining Group, we are seeking a highly motivated Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for leading and facilitating root cause analysis teams, coordinating the review of quality and environmental procedures, and supporting process...

  • Quality Assurance Specialist

    2 weeks ago

    Athens, Georgia, United States Spectraforce Technologies Inc Full time

    Job SummarySpectraforce Technologies Inc is seeking a highly skilled Quality Assurance Specialist to join our team. As a key member of our QA department, you will be responsible for ensuring the quality and compliance of our pharmaceutical products.Key ResponsibilitiesQuality Oversight: Provide quality oversight to the change management system for complex...

  • Quality Assurance Specialist

    18 hours ago

    Athens, Georgia, United States Pilgrim's Full time

    Job Summary: We are seeking a highly skilled Quality Assurance Specialist to join our team at Pilgrim's. The successful candidate will be responsible for ensuring that our products meet the highest standards of quality and safety.Key Responsibilities:Perform HACCP and SSOP checks to ensure compliance with plant, USDA, and customer expectationsConduct quality...

  • Field Quality Assurance Specialist

    3 days ago

    Athens, Georgia, United States Storm Search Full time

    Job Title: Field Quality Assurance SpecialistLocation: [Location] | Travel: 25-30%Are you passionate about quality engineering and eager to work directly with customers to solve real-world problems? Our client is looking for a Field Quality Assurance Specialist to join their team and take ownership of quality assurance for their distribution transformer...

  • Quality Assurance Specialist

    4 weeks ago

    Athens, Georgia, United States Accurus Aerospace Corporation Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at Accurus Aerospace Corporation. As a key member of our quality department, you will play a critical role in ensuring the highest standards of quality in our manufacturing processes.Key ResponsibilitiesConduct thorough inspections of machined aerospace parts and...

  • Quality Assurance Specialist

    4 weeks ago

    Athens, Georgia, United States Spectrum Dynamics Full time

    Quality Assurance at Spectrum Dynamics We are seeking a Quality Inspector to join our team at Spectrum Dynamics. As a Quality Inspector, you will be responsible for ensuring the quality of our products and services. **Key Responsibilities:** * Evaluate the quality of components, assemblies, and production processes * Identify and report any quality issues...

  • Quality Assurance Specialist

    4 weeks ago

    Athens, Georgia, United States Randstad Full time

    Job Summary:We are seeking a Quality Assurance Associate to join our team at Randstad. As a Quality Assurance Associate, you will be responsible for inspecting parts to ensure they meet company guidelines. You will also be required to use and read inspection gauges, and have excellent math skills. Heavy lifting up to 50lbs is also a requirement of this...

  • Quality Assurance Specialist

    4 weeks ago

    Athens, Georgia, United States Randstad Full time

    Job DetailsJob Title: Quality Assurance AssociateLocation: Athens, GASalary: $19/hrWork Hours: 8:00AM to 5:00PMJob SummaryWe are seeking a Quality Assurance Associate to join our team at Randstad. As a Quality Assurance Associate, you will be responsible for inspecting parts and ensuring they meet company guidelines. You will also be required to use and read...

  • Quality Assurance Specialist

    2 weeks ago

    Athens, Georgia, United States E & E Manufacturing Inc Full time

    Job SummaryWe are seeking a highly skilled Quality Engineer to join our team at E & E Manufacturing Inc. As a Quality Engineer, you will play a critical role in ensuring the quality of our products and processes.Key Responsibilities:Develop and implement quality standards and procedures to ensure compliance with regulatory requirements and customer...

  • Quality Assurance Specialist

    2 days ago

    Athens, Georgia, United States E & E Manufacturing Inc Full time

    Job OverviewWe are seeking a highly skilled Quality Engineer to join our team at E & E Manufacturing Inc. As a Quality Engineer, you will play a critical role in ensuring the highest quality standards are met in our metal stamping and pre-assembly automotive manufacturing processes.Key ResponsibilitiesDevelop and implement quality standards and procedures to...

  • Quality Assurance Specialist

    2 days ago

    Athens, Georgia, United States E & E Manufacturing Inc Full time

    Job SummaryWe are seeking a highly skilled Quality Engineer to join our team at E & E Manufacturing Inc. As a Quality Engineer, you will play a critical role in ensuring the quality of our products and processes.Key Responsibilities:Develop and implement quality standards and procedures to ensure compliance with regulatory requirements and customer...

  • Quality Assurance Manager

    1 day ago

    Athens, Georgia, United States Power Partners Full time

    Quality Assurance ManagerAt Power Partners, we are seeking a highly skilled Quality Assurance Manager to join our team. As a key member of our quality management structure, you will be responsible for ensuring the highest standards of quality across our organization.Key Responsibilities:Develop and implement quality assurance strategies and procedures to...

  • Quality Assurance Specialist

    2 weeks ago

    Athens, Georgia, United States Spectraforce Technologies Inc Full time

    Job Title: QA Associate IIIAt Spectraforce Technologies Inc, we are seeking a highly skilled QA Associate III to join our team. As a QA Associate III, you will play a critical role in ensuring the quality and compliance of our manufacturing operations.Key Responsibilities:Execute QA operations and oversee junior team members in assessing, evaluating, and...

  • Quality Assurance Specialist

    2 days ago

    Athens, Georgia, United States E & E Manufacturing Inc Full time

    Job SummaryWe are seeking a highly skilled Quality Engineer to join our team at E & E Manufacturing Inc. As a Quality Engineer, you will be responsible for planning and directing activities related to the development, application, and maintenance of quality standards, customer satisfaction, and operating systems compliance.Key Responsibilities:Working...

  • Quality Assurance Manager

    2 days ago

    Athens, Georgia, United States Cynet Systems Full time

    Job Overview: At Cynet Systems, we are seeking a skilled Warranty Engineer to lead our quality improvement initiatives. Responsibilities: * Collaborate with cross-functional teams to drive quality enhancements * Develop and deliver stakeholder communications in PowerPoint * Schedule and conduct quality meetings and conferences with customers and...

  • Quality Assurance Team Lead

    2 days ago

    Athens, Georgia, United States FireStarters Recruiting Full time

    Job Title: Quality Assurance SupervisorThis is a challenging and rewarding role that requires a strong leader to oversee the quality and food safety programs within our plant. As a Quality Assurance Supervisor, you will be responsible for ensuring that our products meet the highest standards of quality and safety.Key Responsibilities:Organize and coordinate...

  • Quality Assurance Engineer

    19 hours ago

    Athens, Georgia, United States IBM Full time

    Job DescriptionAs a Quality Assurance Engineer at IBM, you will play a critical role in ensuring the quality of software applications. Your analytical and technical skills will directly impact the quality of the software we create.Come work in an agile environment where you will help each iteration reach the next level. Whether the testing is manual,...

  • Quality Assurance Manager

    1 week ago

    Athens, Georgia, United States FireStarters Recruiting Full time

    Job Title: Quality Assurance SupervisorThis position is responsible for overseeing the Food Safety and Quality (FSQA) team and quality programs, including planning and implementing the quality management program.Key Responsibilities:Organize and coordinate FSQA team activities for implementation of quality and food safety programs (HACCP and SSOP) and...

  • Quality Assurance Specialist

    2 days ago

    Athens, Georgia, United States American Refining Group Full time

    Job Title: Quality EngineerAt American Refining Group, we are seeking a highly motivated and experienced Quality Engineer to join our team. As a Quality Engineer, you will play a critical role in ensuring the quality and reliability of our products and processes.Key Responsibilities:Lead and facilitate Root Cause Analysis teams to identify and resolve...