QC-Associate Scientist, Raw Material Inspection and Sampling

Just is seeking a motivated and creative Associate Scientist who desires a significant opportunity to improve worldwide access to biotherapeutics. The new Associate Scientist will join a fast-paced, collaborative, and multidisciplinary Quality Control team.

This role will be responsible for supporting the QC Raw Materials program by inspecting and sampling incoming raw materials and manufacturing supplies, performing related equipment cleaning and maintenance, and providing documentation support. In addition, the Associate Scientist will partner with Manufacturing, Materials Management, Quality Assurance, Procurement, QC staff, and outsourced testing laboratories to meet business goals and compliance requirements. As a key member of the QC group, the successful candidate will have experience with good documentation practices (GDP), be detail oriented, be internally motivated, and skilled at working independently. Experience with fume hoods, laminar flow hoods, balances, aseptic technique, and cleanroom gowning is highly desired. The ideal candidate has strong written and verbal communication skills, multitasks effectively, and works well both independently and in teams.

Responsibilities:

• Execute the daily activities (in warehouse and laboratory environments) of the QC Raw Material group in support of inspection, sampling, and testing as per established procedures and compendial methods
• Inspect material containers, labels, and associated documentation for integrity and compliance with written specifications
• Initiate investigation for any compromised containers or compliance issues during the sampling/inspection process
• Store and assist with inventory management of raw material reserve samples
• Coordinate attribute testing (internal or external) for lot release
• Maintain supply stocks, clean lab spaces, and ship samples with documented Chain of Custody
• Write, revise, or review Standard Operating Procedures (SOPs) and work aids
• Assist QC Laboratory Scientists with reagent preparation and equipment maintenance, as necessary
• Provide subject matter expertise during internal project team meetings
• Collaborate with Quality Assurance, Manufacturing, Material Management, and other functions to ensure internal timelines, testing TAT, and team milestones are achieved
• Use various software tools to support tracking of material release status (Excel, SAP, LIMS, etc.)
• Use various laboratory equipment and instruments
• Must be proficient with aseptic sampling techniques and must ensure all corresponding documentation is ALCOA
• Must maintain a clean and organized work area to ensure lot segregation and prevent cross contamination

Minimum Required Qualifications:

• BS Chemistry or related science, or Associate Degree with minimum two years related experience
• Knowledge of current practices and procedures used in analytical laboratory
• Knowledge of Material Safety Data Sheets and safety precautions for tasks involved
• Ability to follow detailed written procedures
• Ability to understand and follow compendial (USP, EP) testing instructions
• Legible penmanship
• Knowledge of laboratory equipment
• Ability to perform multiple tasks simultaneously, manage time effectively, and adapt to changing priorities
• Demonstrates attention to detail
• Strong adherence to data integrity requirements
• Ability to succeed with minimal supervision
• Excellent oral and written communication skills
• Must demonstrate initiative, resourcefulness, and flexibility to work independently and as part of a team
• Good organizational skills with attention to detail
• Ability to interact constructively with co-workers
• Ability to lift up to 60 pounds; kneeling, crouching, twisting the upper body, walking, bending, stooping, pushing, pulling, and reaching without accommodation
• Ability to routinely wear applicable personal protective equipment (PPE)
• Ability to work with various laboratory cleaning agents and chemicals
• Ability to train on and wear a respirator, as applicable
• Tolerance of exposure to cold-room (2-8°C) conditions
• Tolerance of medium noise levels

Preferred Qualifications:

• Demonstrated meticulous attention and sense of craftsmanship
• Experience in a raw materials or chemistry laboratory
• Experience in a quality control or production environment in a cGMP facility
• Experience with aseptic technique