QC Microbiology Specialist I - Documentation Review

Andelyn-Biosciences; Columbus (OH); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) Match

Paid Time Off (160 hours annually)

11 Company Holidays + 2 floating

Life Insurance

Job summary

Andelyn Biosciences in Columbus, OH, is seeking a GMP QC Scientist I to support daily GMP QC laboratory operations and ensure compliance with 21 CFR Part 211 Subpart I and Part 11. The role collaborates with QC Management and senior staff on investigations, data management, and SOP updates to maintain high-quality standards.

The candidate will assist with assay performance, material handling, and documentation, while prioritizing accuracy, regulatory adherence, and teamwork in a fast-paced

Qualifications

• Must possess a relevant four-year degree in life sciences.
• Experience in highly regulated fields preferred.
• Excellent communication, organization, and project management skills.

Responsibilities

• Support daily GMP QC laboratory operations and ensure regulatory compliance.
• Assist with investigations, data management, and SOP revisions.
• Maintain documentation per SOPs and QA guidelines.
• Collaborate with QC Management and senior staff on projects.
• Respond to alarm notifications for storage units.
• Demonstrate integrity and attention to detail while following established procedures.

Skills

Life sciences background

Regulated environment experience

Project management

Communication skills

MS Office

Education

Bachelor's degree in life sciences

Tools

MS Office

Job description

Andelyn Biosciences is a biopharmaceutical Contract Development and Manufacturing Organization (CDMO) that specializes in advancing novel gene therapies from concept to commercialization.Located inColumbus, OH, the company operates out of the Andelyn Corporate Center (ACC) for clinical and commercial cGMP manufacturing of viral vectors and plasmids and the Andelyn Development Center (ADC) for preclinical non-cGMP activities.

Our Values are founded in our origin story.

The name“Andelyn”is a hybrid of two gene therapypatientswho 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 acceleratethedevelopment and manufacturing of innovative therapies to bring more treatments to more patients. We are Turning Hope Into Reality™ through ourACCTSions.

A CCOUNTABLE in our actions.

C OMPASSIONATE in our thinking.

T RUSTWORTHY in our communications.

S UPPORTIVE of one another.

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

What you will do.

The GMP Quality Control (QC) Scientist I will perform assigned tasks to support the daily operations of the GMP QC laboratory. The primary objective is to ensure that all activities within the GMP QC laboratory facility comply with the requisite regulations (21 CFR Part 211 Subpart I, 21 CFR Part 11, et. al.). Working in close collaboration with QC Management, and senior QC staff the Scientist I will aid all day-to-day lab operations, including project and timeline management, materials management, assisting with laboratory investigations, SOP generation and revision, and assay performance. The Scientist I will aid QC Management in ensuring that their assigned tasks are performed by following appropriate regulatory practices, analytical methods, and Standard Operating Procedures (SOPs) for GMP.

.

• Operate within the Quality Management System applicable to the manufacture of phase-appropriate material in the CMF
• Maintain compliance with applicable regulatory requirements for cellular and gene therapy products
• Works in close collaboration with the QC Management and senior QC staff to cultivate and enact strategic direction of the GMP area including determination of schedule and project timelines/capabilities.
• Provides QC Management with all laboratory data generated from QC laboratory tasks, including in-process, release, and stability testing. Manages and reviews the compilation of all data and ensures its correctness
• Assists in shipment and communications with all external QC laboratory activities in coordination with QC Supervisor
• Assists QC Management with the management of laboratory investigations, the QC portion of deviation investigations, OOS results, process change controls, and required process SOP revision and remediation
• Works in close collaboration with the QC Management and senior QC staff to ensure continuous improvement objectives are identified and met using metrics and other statistical means
• Works in close collaboration with the QC Management and senior QC staff to ensure new projects and technologies are sought for incorporation into the GMP area
• Respond to, and take action from, alarm notifications from the applicable monitoring system(s) for laboratory temperature-controlled storage units that occur at any point during the assigned period of responsibility .
• Exercise discretion, judgment, and personal responsibility
• Demonstrate a high level of integrity
• Operate within the Quality Management System applicable to the manufacture of phase-appropriate material in the CMF
• Maintain compliance with applicable regulatory requirements for cellular and gene therapy products
• Attention to detail in all job functions
• Performs by established policies, procedures, and techniques and requires training common experience or working knowledge related to the tasks performed
• Identifies problems and performs tasks as assigned
• Work under the general supervision of senior staff and leadership
• Works in a diverse and collaborative team environment utilizing clear 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
• Nominal fiscal responsibility
• Other duties as assigned

What you bring to the team.

• Must possess a relevant four-year degree, a background in the life sciences, biotechnology, or gene therapy industries preferred
• Experience in highly regulated fields preferred
• Excellent communication, organization, and project management skills with the ability to manage multiple projects efficiently and adjust as priorities change.
• Must be literate in Microsoft Office (PowerPoint, Excel, Word)
• 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

What you can expect when working at Andelyn.

• The pride in contributing to the development and manufacturing of lifesaving therapies.
• The invaluable experience of being a part of building the foundation of a new organization.
• The opportunity to collaborate with experts who have over 10 years in the gene therapy field.
• Competitive compensation
• Eligible on 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)

The above list of duties is intended to describe the general nature of the work and the type of work that a potential employee: is expected to perform.

• The list is not exhaustive and includes only representative examples.
• The list of duties may evolve over time.

Andelyn Biosciences is committed to a diverse and inclusive workplace. Andelyn is an equal opportunity employer and does not discriminate based on race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or another legally protected status.