QC Analytical Scientist

Role Summary

QC Analytical Scientist responsible for a unique opportunity to facilitate the startup of the GMP testing laboratory. The role includes conducting method transfers, verifications/validations per USP and ICH guidelines, and potential method development. This position supports and assists with delivering project timelines and milestones, while ensuring quality, safety, efficacy, and regulatory compliance.

Responsibilities

• Support the startup of the QC Laboratory and its transition to routine analytical testing.
• Support technology transfer to the manufacturing site by performing method verifications, validations, and transfers for the QC Laboratory and related manufacturing studies.
• Perform and review instrument qualifications and manage calibrations.
• Author, revise, and implement documentation such as standard operating procedures for the QC Laboratory.
• Support evaluation of test methods and adaptation of processes for commercial purposes.
• Independently write and implement study protocols and reports.
• Maintain accurate documentation in compliance with current Good Manufacturing Practices (cGMP).
• Perform QC analyses with instruments (wet chemistry, HPLC, GC, KF, FTIR, UV-VIS) and conduct analyses and peer reviews.
• Identify and document deviations and conduct laboratory investigations.

Qualifications

• Required: Bachelor’s Degree in a Scientific field with minimum 3–5 years of experience in the pharmaceutical industry.
• Required: Experience with method validation/verification/transfers.
• Preferred: Experience performing instrument and software qualifications.
• Preferred: Experience with USP, CFR, ICH, and ISO regulations and guidelines as well as Quality by Design (QbD) principles.
• Required: Experience in relevant laboratory, computer, and data analysis skills.
• Preferred: NMR experience.
• Required: Strong organizational abilities, problem-solving skills, resourceful, and accountable.

Skills

• Knowledge of quality system methodologies (e.g., Failure Mode Effect Analysis, Pareto Analysis; understanding of Six Sigma).
• Ability to handle a wide variety of tasks under critical time constraints.
• Ability to work independently and in a team; collaborative, self-motivated, proactive, and able to think critically.
• Flexibility to work varied schedules including potential weekends or off-hours as needed.