QC RM Analyst II

Forge Biologics•Columbus, OH

15h•Onsite

About The Position

We are currently seeking an Analyst II, Quality Control (Raw Materials) to join the Forge Biologics team. In this role, you will be responsible for conducting testing and evaluation of raw materials used in AAV vector production. Your work will involve material sampling and executing various analytical tests per the processes defined within SOP documents in a cGMP compliant manner. Additionally, you will be responsible for performing comparisons between measured results and expected criteria and communicating those comparisons in a timely and thorough way. Your contribution will be essential in maintaining the integrity and safety of our gene therapy products.

Requirements

Associate’s or Bachelor’s Degree in Biology, Biochemistry, Chemistry or a related discipline.
Familiarity with basic laboratory techniques and analytical methods.
Ability to lift 50lbs

Nice To Haves

Prior experience in a laboratory or quality control environment.
Sampling in a clean room environment
Understanding of cGMP and regulatory guidelines.

Responsibilities

Inspect all materials that arrive at the facility for integrity and quality.
Sample materials in a clean room environment
Communicate between departments to ensure all operations have all required inspected materials.
Perform routine testing and analysis of raw materials using established protocols and analytical methods.
Conduct a range of tests, including but not limited to identity, purity, potency, and microbial contamination, on incoming raw materials.
Accurately document test results, observations, and procedures in accordance with Good Documentation Practices (GDP).
Collaborate with the procurement team to ensure timely receipt and testing of raw materials.
Escalate any non-conformance or deviations to appropriate channels for investigation and resolution.
Assist in the development and optimization of new testing methods and procedures.
Contributes to the maintenance, calibration, and qualification of laboratory equipment.
Supports the onboarding and training of team members in routine tasks and established procedures
Adhere to Standard Operating Procedures (SOPs), cGMP guidelines, and regulatory requirements.

Benefits

Health, dental and vision insurance start your first day – with 90% of premiums covered for you and your family.
A competitive paid time off plan
12 weeks of fully paid parental leave
Annual bonus opportunities for all full-time team members.
401(k) with company match
Special employee discounts, including childcare and dependent care savings.
Onsite fitness facility at The Hearth.
Mental health counseling and financial planning services through our Employee Assistance Program.
Employer-paid short and long-term disability coverage
A fully stocked kitchen with free snacks and beverages
Ongoing professional development resources, training, and mentorship programs