Analyst I, QC Raw Materials
About The Position
We are currently seeking an Analyst I, Quality Control (Raw Materials) to join the Forge Biologics team. In this role, you will be responsible for performing incoming inspection to evaluate raw materials used in AAV vector production against all Forge defined requirements. Your work will involve executing various 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
- Bachelor’s Degree in Biology, Biochemistry, Chemistry or a related discipline.
- Attention to detail, accuracy, and the ability to follow protocols.
- Strong organizational and documentation skills.
- Effective communication and ability to work within a team.
- Willingness to learn and adapt to new techniques and technologies.
Nice To Haves
- Prior experience in a laboratory or quality control environment.
- Understanding of cGMP and regulatory guidelines.
Responsibilities
- Inspect all materials that arrive at the facility for integrity and quality.
- Communicate between departments to ensure operations teams have all required materials.
- Facilitate a range of activities to support material testing, including but not limited to identity, purity, potency, and microbial contamination, on incoming and Forge produced 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 disposition of raw materials.
- Escalate any non-conformance or deviations to appropriate channels for investigation and resolution.
- Assist in the development and optimization of practices and procedures.
- Contribute to the maintenance, calibration, and qualification of laboratory equipment.
- Adhere to Standard Operating Procedures (SOPs), cGMP guidelines, and regulatory requirements.
- Maintain a clean and organized work space and adhere to safety protocols.
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
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
