QC Analyst II; Onsite

Purpose and Scope

Performs routine testing of raw materials, cleaning samples, bulk intermediate and finished product, and/or stability samples, according to established regulatory protocols and procedures.

• Prioritizes tasks and performs job duties with minimal guidance from management. Works to complete tasks in an efficient manner, and is a productive member of the department.
• Performs analyses on a variety of samples using intermediate preparation techniques and analysis methods. Employee will be trained and become proficient in the intermediate preparation techniques and analysis methods.
• Actively contributes to short‑term team objectives, focusing on routine tasks while ensuring consistency and quality.
• Develops and implements strategies to overcome daily challenges and improve workflows.
• Applies intermediate technical skills and a foundational understanding of cGMP, organizational structure, and departmental processes to complete standard work assignments.
• Takes the initiative to support projects and actions demonstrating a continuous improvement mindset.
• Delivers high‑quality work on a consistent basis, meeting deadlines and maintaining reliability in daily tasks.
• Proactively develops actionable solutions based on an understanding of the problem, collaborating with team members when necessary to ensure the solution is effective and aligns with organizational goals and regulatory requirements.
• Demonstrates strong focus and concentration to complete tasks with minimal mistakes, maintaining quality under pressure, and ensuring focus during work to support infrequent preventable errors.
• Takes responsibility for individual contributions and accepts accountability for performance.
• Actively participates in team activities, challenges, and shared responsibilities (such as T‑cards, archival, etc.), showing enthusiasm and a can‑do attitude to inspire others, while maintaining professionalism.
• Overcomes challenges with a positive attitude, staying focused on the goal even in the face of setbacks. Models good laboratory stewardship by maintaining a clean, orderly and safe work environment and proactively restocks low inventory items and routine lab supplies.
• At the direction of management, trains junior analysts in analysis methods and lab techniques.
• Accountable for documenting all activities and maintaining records according to good documentation practices.
• Accountable for proper use, care and maintenance of instrumentation.
• Provides detailed accounts of testing performed to investigators. Under the direct supervision of an investigator, may perform investigational testing.
• Makes scientific recommendations to management/technical writers regarding QC procedures.
• Completes tasks on time and works to eliminate repeat errors. Follows all procedures applicable to job functions to ensure high quality of work.
• Responsible for ensuring that company and regulatory data integrity guidelines are consistently followed.
• Accountable for maintaining an atmosphere of teamwork, cordiality and respect towards co‑workers and is willing to assist co‑workers in the completion of tasks.
• Performs intermediate method transfers.
• Represents the department by providing accounts of testing performed and results of method transfer activities and assists with troubleshooting aberrant method transfer results, if necessary.
• Interacts respectfully with all other employees both inside and outside of the department and members of management and shows interest in others' input and reasoning. Appropriately resolves differences of opinion.
• Upon delegation, may be responsible for representing the QC chemistry laboratory when communicating with outside departments and vendors.
• Identifies issues and escalates those issues to the department senior leadership or management as appropriate.
• Participates in required annual hazardous waste training. Hazardous waste involvement may include, but is not limited to container and tank management and inspections, generation of hazardous waste as a part of production or sampling processes and transfer of hazardous waste between lab procedure area, satellite accumulation and storage. Respond to spills per the Chemical…