Associate II, Quality Control, Stability
Moderna
Summary
Moderna is seeking a Quality Control Stability Associate II to join our QC Stability team in Norwood, MA. This role will support the routine execution of GMP stability programs across clinical and commercial programs, ensuring activities are performed in accordance with established procedures, policies, and applicable GxP and GMP requirements.
Job description
Here's What You'll Do
- Performing day-to-day routine stability program operations, such as stability sample pulls, sample aliquoting, sample submissions to testing labs, set-downs, sample verifications, additional sample requests, and shipment preparations for external labs.
- Creating, maintaining, and assisting with stability scheduling ensuring stability sample pulls occur as scheduled and within defined timelines.
- Ensuring proper operation and functioning of stability controlled-temperature units and cold rooms within validated temperature ranges and loading patterns.
- Responding to notifications of out-of-range controlled-temperature units and cold rooms within scheduled working hours and escalating to QC Stability management.
- Ensuring proper handling of stability study materials and stability samples with attention to all material handling requirements in applicable procedures and protocols.
- Managing and stocking of QC lab supplies and consumables required for performing stability operations.
- Ensuring compliance with all lab safety requirements.
- Following all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.
- Executing tasks precisely as defined in internal guiding documents including but not limited to standard operating procedures (SOPs) and work instructions.
- Following Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.
- Completing training in assigned required learning plan according to the defined timing and the prescribed requalification cadence.
- May support and/or participate in audits and regulatory inspections.
Here's What You'll Need (Basic Qualifications)
- Education: Bachelor's degree in relevant scientific discipline
- Experience: 2-3 years in a GMP QC laboratory setting with focus on Stability (preferable in life science or equivalent)
- Minimum knowledge required: cGMPs, general laboratory safety
- Minimum skills required: Pipetting
- Proficiency with Microsoft Office Programs
- Familiarity with electronic databases (e.g. LIMS, SAP, eQMS, CMMS)
- Strong written and oral communication skills as well as organizational skills
Requirements
- Bachelor's degree in relevant scientific discipline
- 2-3 years in a GMP QC laboratory setting with focus on Stability
- cGMPs knowledge
- General laboratory safety knowledge
- Pipetting proficiency
- Proficiency with Microsoft Office Programs
- Familiarity with electronic databases (e.g. LIMS, SAP, eQMS, CMMS)
- Strong written and oral communication skills
- Organizational skills
Benefits
- Healthcare
- Fitness support
- Mindfulness support
- Mental health support
- Family planning benefits
- Fertility support
- Adoption support
- Surrogacy support
- Paid time off
- Vacation
- Volunteer days
- Sabbatical
- Global recharge days
- Discretionary year-end shutdown
- Savings and investments
Company overview
Moderna, Inc. is a pioneering American biotechnology and pharmaceutical company headquartered in Cambridge, Massachusetts, that has revolutionized the field of medicine through its groundbreaking messenger RNA (mRNA) technology. Founded in 2010, the company has established itself as a global leader in RNA therapeutics, primarily focusing on mRNA vaccines and treatments. Moderna's innovative platform uses mRNA to provide cellular instructions for producing proteins that trigger immune responses, creating a new category of medicines with significant potential to improve patient outcomes across various therapeutic areas. The company gained worldwide recognition during the COVID-19 pandemic for developing one of the earliest and most effective mRNA vaccines, which demonstrated the transformative potential of its technology platform. Beyond infectious diseases, Moderna is advancing a diverse pipeline of 44 treatment and vaccine candidates across infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune conditions. With approximately 5,800 employees and a strong commitment to scientific innovation, Moderna continues to expand its manufacturing capabilities and research initiatives to deliver the greatest possible impact through mRNA medicines.