Sr. Manufacturing Associate (Visual Inspection)
We are looking to fill a full-time position for a Senior Manufacturing Associate of the Visual Inspection group who will primarily be tasked with the visual inspection of finished drug products contained in vials. The Visual Inspection group is responsible for inspecting several hundred units (i.e., glass vials) of drug product per day, following a detailed SOP for identifying and separating out product defects such as scratches, cracks, and barely visible particles contained within the vial contents. The Visual Inspection group plays a critical role in the quality control manufacture of human medicinal drug product. He/She will work to support the release of medicinal drug product batches and will effectively communicate aberrant observations from the routine visual inspection operation to Production and Quality management. The candidate will have experience working within a GMP environment.
Here's What You'll Do:
- Visual inspection of several hundred units (i.e., glass vials) of drug product per day, following a detailed SOP for identifying and separating out product defects such as scratches, cracks, and barely visible particles contained within the vial contents.
- Writing and updating SOPs
- Adherence to cGMPs
- Support/conduct GMP quality investigations into any anomalies observed during the routine 100% visual inspection of drug product batches. Such investigations will require that the senior associate work with various subject matter experts across the organization to identify root cause and appropriate Corrective/Preventive Actions (i.e. CAPA).
- Ensure timely and effective CAPA implementation for any root cause investigations that identify contributing factors related to visual Inspection operations.
- Carefully document all findings according to standard operating procedures.
- Ensures the controlled inspection area is clean and remains in a state of control at all times.
- Ensures that visual inspection equipment is maintained in good working order including compliance to the metrology, preventive maintenance and requalification requirements.
Here's What You'll Bring to the Table:
- BS/BA with 5+ years' experience working in a cGMP environment.
- The successful candidate must have 20/20 vision (corrected vision allowed - ie., glasses, contact lens) and maintain the ability to see all colors across the visible spectrum. An eye test will be required upon hiring to confirm vision acuity and will be administered annually thereafter.
- Experience working in a visual inspection role.
- Experience writing SOP's and/or Quality approved documentation
- Willingness to work as a team to support other departments when needed.
- Solid communication skills
- Ability to repeatedly follow detailed instructions and maintain inspection techniques for which the candidate will receive extensive training.
- Package and label materials for storage and/or shipment
- Good hand/finger dexterity
- Good hand and eye coordination
- Ability to sit for extended periods of time
- Ability to perform simple math
Here's What We'll Bring to the Table:
- Daily on-site catered lunches in Cambridge.
- Company-provided iPhone.
- Free parking, monthly subway pass or a subsidized commuter rail pass.
- Highly competitive healthcare coverage. Including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP.
- Flexible Spending Accounts for medical expenses and dependent care expenses.
- 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately.
- A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability
- Voluntary legal assistance plan
- 15 days' vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays.
- Adoption assistance, competitive parental leave, discount to local childcare centers, as well as access to Care.com
Why join Moderna Therapeutics
We are pioneering a new class of medicines made of messenger RNA, or mRNA. The potential implications of using mRNA as a drug are significant and far-reaching. It could transform not only how certain diseases are treated but also how medicines are discovered, developed and manufactured - at a breadth, scale and speed not common in the biopharma industry.
Since our founding in 2011, we have built the industry's leading mRNA technology platform, the infrastructure to accelerate drug discovery and speed early development, a rapidly expanding pipeline, and an unparalleled team. Our development pipeline includes development candidates for mRNA-based vaccines and therapies spanning several therapeutic areas, and we have multiple clinical trials already underway with other development candidates progressing toward the clinic. In addition, we have a number of discovery programs that are advancing toward the development stage.
We invite you to explore our site to learn more about our company and how we are advancing the promise of mRNA science to improve health and impact lives around the world.
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and
qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.