GMP QC Specialist II – Starting Materials

Valid8 Financial, Inc.; Columbus (OH); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Paid Time Off (PTO) - 160 hours

Holidays

Life Insurance

401(k) Match

Disability Insurance

Parental Leave

Tuition Reimbursement

Student Loan Repayment Assistance

LinkedIn Learning

Employee Assistance Program

Flexible work options

Job summary

Andelyn Biosciences in Columbus, OH is seeking a GMP Quality Control (QC) Specialist II SM to support QC Starting Materials operations in a cGMP manufacturing environment. You will collaborate with QC Management and senior staff to ensure regulatory compliance, write SOPs, manage data, and help drive continuous improvement in material testing, release, and investigations.

The role requires a life sciences degree pair with 3+ years of relevant experience (or Masters/PhD) in biologics or gene

Qualifications

• Must possess relevant four-year degree OR relevant master’s OR relevant Ph.D., background in the life sciences, biotechnology, or gene therapy industries preferred
• Three years relevant (w/4 YR deg) OR no experience with (w/Masters)
• Experience in biologics or gene therapy preferred
• Experience in highly regulated field preferred
• Excellent communication, organization, and project management skills with the ability to manage multiple projects efficiently and adjust as priorities change
• Must be 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

Responsibilities

• Operate within Quality Management System for cGMP material
• Maintain compliance with regulatory requirements for cellular and gene therapy products
• Collaborate with QC Management and senior staff to guide QC Starting Materials strategy and timelines
• Write and revise SOPs affecting QC Starting Materials operations
• Provide lab data to QC Management and ensure data integrity
• Support operation, calibration, validation, cleaning of QC equipment and systems
• Assist with purchasing and coordination with external QC labs for documentation
• Assist investigations and change controls related to QC Starting Materials
• Contribute to continuous improvement with metrics and data analysis
• Collaborate to explore new projects and technologies for QC Starting Materials
• Respond to alarm notifications from monitoring systems in temperature-controlled storage
• Demonstrate integrity, attention to detail, and adherence to SOPs
• Work with independence as needed and contribute to a collaborative team
• Document all activities per SOPs
• Make decisions based on established procedures
• Occasional travel may be required
• Limited involvement in audits and in customer relations

Skills

Biologics or gene therapy experience

Regulated environment

Project management

MS Office proficiency

Communication skills

Independent work

Education

Bachelor’s degree in Life Sciences

Master’s degree in Life Sciences

PhD in Life Sciences

Tools

None

Job description

Andelyn Biosciences in Columbus, OH is seeking a GMP Quality Control (QC) Specialist II SM to support QC Starting Materials operations in a cGMP manufacturing environment. You will collaborate with QC Management and senior staff to ensure regulatory compliance, write SOPs, manage data, and help drive continuous improvement in material testing, release, and investigations.

The role requires a life sciences degree pair with 3+ years of relevant experience (or Masters/PhD) in biologics or gene