Senior Quality Assurance Specialist

Found in: beBee jobs US - 2 weeks ago

Columbus, Ohio, United States Andelyn Biosciences Full time

Overview of Andelyn Biosciences

Andelyn Biosciences is a biopharmaceutical Contract Development and Manufacturing Organization (CDMO) focused on advancing novel gene therapies from concept to commercialization. Located in the heart of Columbus, OH, the company has expanded to three buildings with more than 250,000 combined square feet of space. The Andelyn Corporate Center (ACC) is dedicated to cGMP manufacturing, the Andelyn Development Center (ADC) for preclinical non-cGMP activities, and the Andelyn Plasmid Center (APC) for research and cGMP plasmid production.

Our Values are founded in our origin story.

The name "Andelyn" is a hybrid of two gene therapy patients who participated in pivotal Phase I clinical trials at Nationwide Children's Hospital. Andrew received the first U.S. investigational gene therapy for Duchenne muscular dystrophy in 2006. Evelyn received experimental gene therapy for spinal muscular atrophy in 2015. "Andelyn" combines their names to represent all the families who have courageously participated in the research that makes today's gene therapies possible.

Through this journey, we have been able to accelerate the development and manufacturing of innovative therapies to bring more treatments to more patients. We are Pioneering Solutions that Turn Hope into RealityTM through our ACCTSions.

ACCOUNTABLE in our actions.

CURIOUS to discover.

COMPASSIONATE in our thinking.

TRUSTWORTHY in our communications.

SUPPORTIVE of one another.

Employees are expected to perform the following essential functions under the framework of our ACCTSions.

What you will do.

The Senior QA Specialist, QA Investigations/CAPA is an individual contributor role primarily responsible for conducting technical quality compliance-related activities in accordance with GxP regulations and internal SOP. This SME ensures deviations are thoroughly investigated, the root cause is determined, and appropriate corrective actions are identified and implemented based on associated risk to process, compliance or SISPQ. Additionally, the individual is responsible for the oversight and communication of critical metrics regarding deviations and CAPAs. The individual also provides QA review and oversight of Trend Review Reports to identify interrelationships between process inputs and critical process parameters and to identify process shifts.

Oversee and support the prompt evaluation, investigation, closure, and follow-up of unplanned events as well as identify opportunities for continuous improvements.
Works with SMEs to ensure thorough root cause analyses, assess impact to SISPQ, and ensures root cause is addressed through appropriate Corrective/Preventive Actions.
Works to establish appropriate ownership and timelines for CAPAs about the risk related to the event or issue.
Assesses final supporting documentation to complete/close CAPAs as adequate. Conducts CAPA effectiveness checks for high-risk events.
Communicates critical metrics regarding deviations and CAPAs and chairs the Investigation Review Board meeting.
Provide oversight and input to Trend Review Reporting and Lifecycle Review activities to identify and address process shifts and trends.
Acts as the SME and trainer for the TrackWise Investigation/CAPA module.
Prepares and reports quality metrics as necessary to ensure upper management is aware of trends and ongoing activities relevant to investigations, CAPA, etc.
Ensures that documentation is maintained in accordance with internal procedures and regulatory requirements.
Assess accuracy and compliance of procedures as an SOP author, reviewer, and approver and work with cross-functional approval panels for timely, accurate document revisions.
Supports and maintains an environment that fosters communication and teamwork within Quality Assurance and related departments.
Performs the function of Senior QA Specialist and other related assignments and duties as required and assigned.

What you bring to the team.
Minimum of 5 years' experience GMP/Biopharmaceutical/Biotech Industry/FDA, 3-5 years specific QA hands-on experience in a pharmaceutical environment, cell and gene therapy experience preferred.
Bachelor's Degree in a technical or scientific discipline or equivalent
• Operational knowledge of cGMP regulations and guidelines including but not limited to U.S. Code of Federal Regulations 21 CFR Part 11 and Part 210 & 211
Demonstrated Project Management abilities to lead and manage several projects, meeting deadlines, and use critical thinking skills to problem solve effectively.
Excellent verbal and written communication skills at all levels of the organization. Technical writing is required.
Experience with the authoring and execution of Quality documentation including SOPs, CAPAs, and Investigations.
Experience with FDA, and EMA inspection interaction.
Strong experience working in cross-functional teams. Ability to influence, negotiate, manage conflict, and collaborate.
Must demonstrate a "can-do" attitude.
• Proficient in computer skills as a business tool, specific work experience using Microsoft applications (Word, Excel, PowerPoint). Knowledge of application software such as Trackwise, and SAP, preferred.

What you can expect when working at Andelyn.
The pride of contributing to the development and manufacturing of life-saving therapies
The invaluable experience of being a part of building the foundation of a new organization.
The opportunity to work alongside experts that have over 10 years in the gene therapy field.
Competitive compensation
Eligible day one for medical, dental and vision insurance plans with basic vision at 100% company-paid
160 hours of Paid Time Off annually
11 Company Paid Holidays plus 2 floating holidays annually.
Company Paid Life Insurance
401(k) Match
Company Paid short and long-term disability.
4 weeks of Paid Parental Leave for birth and adoption
Adoption Assistance
Tuition Reimbursement and Student Loan Repayment Assistance
Company Paid LinkedIn Learning access.
Employee Assistance Programs
Flexible work options (role specific)

Andelyn Biosciences embraces diversity and is an equal opportunity employer and does not discriminate based on race, religion, national origin, gender, gender identity, genetic information, sexual orientation, protected veteran status, disability, age, or another legally protected status. As an organization, we are committed to creating an environment where everyone ACCTS.

  • Senior Specialist, Quality Assurance

    Found in: beBee jobs US - 1 week ago

    Columbus, Ohio, United States Forge Biologics Full time

    Summary: We are currently seeking a Senior Specialist, Quality Assurance (Lab Support) to join the Forge Biologics Team. The Quality Assurance Senior Specialist is responsible for ensuring compliance with regulatory requirements and maintaining the highest quality standards. The QA Senior Specialist will support the Quality Assurance team in activities such...

  • Quality Assurance Administrator

    Found in: beBee jobs US - 3 weeks ago

    Columbus, Ohio, United States MARYHAVEN, INC Full time

    Quality Assurance Administrator Job DescriptionUnique opportunity to join Maryhaven, Central Ohio's largest and most comprehensive behavioral services provider specializing in addiction recovery. We are looking for skilled, talented, and compassionate people to join our team Maryhaven was founded on the principles of Diversity, Equity, and Inclusion in 1953,...

  • Quality Assurance Supervisor

    Found in: beBee jobs US - 1 week ago

    Columbus, Ohio, United States Andelyn Biosciences Full time

    Overview of Andelyn BiosciencesAndelyn Biosciences is a biopharmaceutical Contract Development and Manufacturing Organization (CDMO) focused on advancing novel gene therapies from concept to commercialization. Located in the heart of Columbus, OH, the company has expanded to three buildings with more than 250,000 combined square feet of space. The Andelyn...

  • Quality Assurance Analyst I

    Found in: beBee jobs US - 2 weeks ago

    Columbus, Ohio, United States T. Marzetti Company Full time

    T. Marzetti Company, a wholly owned subsidiary of Lancaster Colony Corporation, is a manufacturer and marketer of specialty food products for the retail and foodservice markets.Our retail brands include Marzetti, New York BakeryTM, Sister Schubert's, Reames, RomanoffCaviar, Amish Kitchens, Angelic Bakehouse, Cardini's, Chatham Village, Flatout, and Inn...

  • Quality Assurance Supervisor

    Found in: beBee jobs US - 6 days ago

    Columbus, Ohio, United States Compass Experience Labs Full time

    MEET COMPASSWe partner with brands to power growth through exceptional customer experience. Our founders were trailblazers in the eComm industry. When they couldn't find a customer service partner that was as innovative as they were, they built it. Many companies view their customer care as a cost center, but we believe it can be so much more If you delight...

  • it cybersecurity specialist

    Found in: beBee jobs US - 1 week ago

    Columbus, Ohio, United States Department Of The Army Full time

    Summary This National Guard position is for a IT CYBERSECURITY SPECIALIST (INFOSEC), Position Description Number D and is part of the OH G6, Ohio Army National Guard.The primary purpose of this position is to provide auditing to ensure secure operations of the network enclave and provide incident response actions as directed by the cybersecurity service...

  • Quality Engineer

    Found in: beBee jobs US - 2 days ago

    Columbus, Ohio, United States Dart Point Full time

    Responsiblties Reviews requirements and specifications and provides feedback. Creates detailed and well-structured test plans and test cases. Enhance and optimize our existing automation test framework. Prioritizes plans and coordinates testing activities. Executes test cases and / or automation scripts. Identifies and documents defects thoroughly. Installs...

  • Compliance Specialist

    Found in: beBee jobs US - 2 weeks ago

    Columbus, Ohio, United States Billhighway Full time

    The Role: Compliance Specialist As a Compliance Specialist you will oversee, evaluates, and support the documentation, validation, and accreditation processes necessary to ensure new and existing information technology meet the organization's information security requirements. Ensure appropriate treatment of risk, compliance, and monitoring assurance from...

  • Avionics Technical Specialist

    Found in: beBee jobs US - 2 weeks ago

    Columbus, Ohio, United States Netjets Full time

    Title: Avionics Technical Specialist (NJUS)Company: NetJets Aviation, Inc.Area of Interest: Aircraft MaintenanceLocation: Columbus, OH, US, 43219 Req ID: 12932Purpose of PositionIs responsible for providing aircraft avionics and/or digital controlled system(s) technical support to the NetJets organization and its vendors. Is appointed and empowered by the...

  • Sr. Data Quality Analyst

    Found in: beBee jobs US - 2 weeks ago

    Columbus, Ohio, United States McKessons Corporate Full time

    an experienced and knowledgeable Senior Data Quality Analyst to join our team and provide expert support for the implementation and development of theSr. Data Quality AnalystKnowledge in languages like Python, R, SQL, etc., for custom data quality checks or integrations.Experience with cloud-based data quality solutions or platforms such as AWS, Azure,...

  • Senior Validation Engineer

    Found in: beBee jobs US - 2 weeks ago

    Columbus, Ohio, United States Abbott Laboratories Full time

    Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.Nourish the...

  • surface maintenance specialist

    Found in: beBee jobs US - 1 week ago

    Columbus, Ohio, United States Department Of The Army Full time

    Summary This National Guard position is for a SURFACE MAINTENANCE SPECIALIST, Position Description Number D and is part of the OH G4 SMO, Ohio Army National Guard.The primary purpose of the work is to analyze and evaluate maintenance operations, production, and procedures; and make recommendations for improvement. This requires practical knowledge of, and...

  • paralegal specialist

    Found in: beBee jobs US - 1 week ago

    Columbus, Ohio, United States Department Of The Army Full time

    Summary This National Guard position is for a PARALEGAL SPECIALIST, Position Description Number D and is part of the OH CoS Command Admin Office, Ohio Army National Guard.The primary purpose of this position is for Paralegal support within the state/territory Staff Judge Advocate's Office providing ancillary legal research and analysis and Managing the...

  • Senior Highway Transportation Engineer/Project Manager

    Found in: beBee jobs US - 2 weeks ago

    Columbus, Ohio, United States Affinity Full time

    Job Description Senior Highway Transportation Engineer/Project Manager Columbus, Ohio.Job Responsibilities Senior Highway Transportation Engineer/Project Manager ?with experience consistent, but not limited to: Monitoring and coordinating client and teaming partners. Working to grow personnel and office disciplines. Coordinate with other leaders across the...

  • surface maintenance specialist

    Found in: beBee jobs US - 3 weeks ago

    Columbus, Ohio, United States Army National Guard Units Full time

    Summary This National Guard position is for a SURFACE MAINTENANCE SPECIALIST, Position Description Number D and is part of the OH G4 SMO, Ohio Army National Guard. The primary purpose of the work is to analyze and evaluate maintenance operations, production, and procedures; and make recommendations for improvement. This requires practical knowledge of, and...

  • Senior Process Architect

    Found in: beBee jobs US - 2 weeks ago

    Columbus, Ohio, United States Burns & McDonnell Full time

    Description The Senior Architect - Process will lead in the development of pharmaceutical and life science projects teams to create world-class designs for Life Science Clients. The Senior Architect - Process will lead the project team throughout the design and construction process and integrate process systems into the resulting architectural concepts and...

  • Senior Outreach Coordinator

    Found in: beBee jobs US - 3 weeks ago

    Columbus, Ohio, United States Ohio State University Full time

    Job Title:Senior Outreach CoordinatorDepartment:University Hospital | AdministrationThe Center for Emergency Medical Services (CEMS) at The Ohio State University Wexner Medical Center serves as an expert resource for all pre-hospital activity by conducting targeted outreach, providing expansive and comprehensive education, and finding innovative ways to...

  • Production Operator- Specialist 2nd shift Columbus Plant

    Found in: beBee jobs US - 2 weeks ago

    Columbus, Ohio, United States Abbott Laboratories Full time

    Nourish the world and your career as part of the Nutrition team at Abbott.Our Nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow, to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac, PediaSure, Pedialyte,...

  • Senior Utility Engineer

    Found in: beBee jobs US - 2 weeks ago

    Columbus, Ohio, United States Abbott Laboratories Full time

    Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.Job...

  • Software Engineer-Senior, Corporate System HR

    Found in: beBee jobs US - 1 week ago

    Columbus, Ohio, United States Marriott Full time

    Job Number Job Category Information TechnologyLocation Marriott International HQ, 7750 Wisconsin Avenue, Bethesda, Maryland, United StatesSchedule Full-TimeLocated Remotely? YRelocation? NPosition Type ManagementJOB SUMMARYMarriott has an exciting opportunity for a Senior Software Engineer – Corporate Systems. This role is part of the team focused on...