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Andelyn Biosciences · 7 hours ago

Senior Specialist, Quality Systems

Columbus, Ohio Metropolitan Area

Full-time

Onsite

Senior Level

5+ years exp

Andelyn Biosciences is a biopharmaceutical Contract Development and Manufacturing Organization specializing in advancing novel gene therapies. The Senior Specialist, Quality Systems role involves providing compliance and quality assurance support for the Quality Management System, ensuring adherence to defined procedures, and managing change controls within the organization.

BiopharmaBiotechnologyClinical TrialsManufacturingProduct Research

H1B Sponsor Likely

Hiring Manager

Pamela Backus-Diggs

Responsibilities

Operate within the Quality Management System applicable to the manufacture of phase appropriate material GMP operations

Works closely with Operations colleagues of all the areas that required the support of the change management group to ensure control of clinical and commercial manufacturing. Track change controls within the Trackwise system to assure the proper implementation and adequate change management process

Responsible for the Change Control Review Board email distribution list and ensuring that it is kept current and updated, as needed

Manage the multiple meetings to coordinate the proper implementation of the change controls and the change management methodology

Act as the main point of contact for Change Controls and provide support to owners and approvers assigned in Trackwise

Assist in the development of action plans and metrics to monitor Change Management within the Andelyn QMS

Act as the owner of the Change Management SOP. Revise, as needed to ensure compliance with regulations and the Andelyn QMS

Track Quality Technical Agreements to ensure reviews are performed following applicable SOPs, and compliance with the requirements of the change control process (Change management approach)

Additional tasks within QA, as assigned

Operates in alignment with established policies, procedures, and techniques, requiring relevant training, practical experience, or a working knowledge of the tasks involved

Solving, correcting, preventing problems, and performing tasks as assigned by leadership, as well as assigning tasks to junior staff

Work to specific measurable objectives requiring operational planning skills with little direct supervision

Leads and supports a diverse and collaborative team environment. Utilizes clear and concise communication to deliver high productivity and contributes to the success of team and goals

Documentation of all activities performed according to SOPs

Make decisions based on established procedures

Other duties as assigned

Qualification

Change Management ProcessCGMP RegulationsQuality Management SystemPharmaceutical ExperienceAseptic ManufacturingProject ManagementMicrosoft OfficeCommunication SkillsOrganizational SkillsClient-focused Mindset

Required

Must possess relevant four-year degree OR relevant Masters OR relevant Ph.D

Five years relevant (w/4 YR deg) OR two years (w/Masters) or 10 years of relevant experience on the area of Change management

Experience in Pharmaceutical, biologics or gene therapy required

Proficient 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, European Directives, ICH guidelines, and cGMP regulations

Experience in commercial and clinical GMP production and ability to provide QA support for both

Experience in Change Management Process and Change Control required

Excellent communication, organization, and project management skills with the ability to manage multiple projects efficiently and adjust as priorities change

Must be highly skilled in Microsoft Office (PowerPoint, Excel, Word) including data interpretation and reporting

Ability to work independently as well as collaboratively in a diverse and inclusive work environment

Must possess a client-focused mindset in daily tasks

Must possess prior experience handling confidential information and the ability to maintain confidentiality

Preferred

background in the Sciences (engineering, chemical or biological), life sciences, biotechnology, or gene therapy industries preferred

Experience in highly regulated field preferred

Experience with aseptic manufacturing operations is highly preferred

Benefits

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)

Company

Andelyn Biosciences

Andelyn Biosciences is a biopharmaceutical company that delivers treatments and therapies for patients.

Founded in 2020

Columbus, Ohio, USA

201-500 employees

https://www.andelynbio.com/

H1B Sponsorship

Andelyn Biosciences has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2023 (2)

2022 (1)