QC Scientist II - Analytical Support

Responsibilities

• Provide technical input for analytical proposals, work statements, test methods, investigations, risk assessments, and client inquiries.
• Collaborate cross-functionally to develop and implement departmental policies and procedures.
• Aid in technical training for analysts, data reviewers, and investigation writers.
• Serve as an interface during method transfer, qualification, and validation processes.
• Perform method risk assessments prior to validation activities and assist with method language and form optimization.
• Advise on Corrective and Preventive Actions (CAPAs) to ensure compliance with analytical methods and site policies.
• Attend FDA inspections, ISO and customer audits, and support external audit response management for analytical concerns.
• Manage critical reagent changes and review/approve internal reference material qualifications and recertifications.
• Expand scientific, technical, and compliance knowledge through literature, conferences, and relevant training.
• Engage in continuous process improvement initiatives and support site safety programs.

Essential Skills

• 3-5 years of experience in HPLC/UPLC within the quality/analytical/pharmaceutical industry.
• Experience with a variety of HPLC/UPLC assays, including SEC, CEX, Glycans, Peptide Map.
• Prior use of EMPOWER software.
• Knowledge of GMP regulations in a cGMP manufacturing environment.
• Strong in analytical chemistry and wet chemistry.
• Experience with ICH and FDA guidelines.
• Proficient in MS Excel, MS PowerPoint, MS Teams, and MS Word.
• Outstanding technical reading and writing skills.
• Knowledge of various analytical techniques: capillary electrophoresis, UPLC/HPLC, ELISA, and cell-based assays.
• Understanding of US and international regulations for pharma/biopharma products.
• Strong interpersonal skills for effective stakeholder influence.

Additional Skills & Qualifications

• Bachelor’s Degree in a Biological Science-related field, preferably Chemistry or Biochemistry.
• Experience in a GMP facility within the biopharmaceutical or pharmaceutical industry.
• 1+ years of experience in a client-facing quality control role.
• Familiarity with standard project management concepts and tools.
• Ability to inspire innovation and team effectiveness.

Work Environment

• This position operates from Monday to Friday with a training period of three months from 8:00 am to 4:30 pm.
• Post-training offers flexible start times covering core hours from 9:00 am to 3:00 pm.
• The role is primarily desk-based, with 10% standing or walking and 90% sitting.
• Personal Protective Equipment (PPE) such as lab coats, gloves, eye protection, and safety shoes are required.
• Exposure to fumes, chemicals, acids, and bases is a part of the work environment.