About The Position

The Associate Scientist, QC Raw Materials is an entry-level, hands-on laboratory role responsible for performing analytical testing to support raw material release in a cGMP-regulated Quality Control laboratory. This role is responsible for executing testing in accordance with approved methods, ensuring data integrity, and supporting timely and compliant material disposition. The position requires strong attention to detail, adherence to procedures, and the ability to work in a fast-paced, team-oriented environment.

Requirements

  • B.S. degree in Chemistry, Pharmaceutical Sciences, or a related scientific discipline.
  • 0–2 years of experience in a cGMP-regulated analytical laboratory environment.
  • Basic familiarity with cGMP documentation practices.
  • Foundational understanding of cGMP regulations and data integrity principles.
  • Strong attention to detail and ability to follow written procedures precisely.
  • Demonstrated analytical and problem-solving skills.
  • Effective written and verbal communication skills.
  • Ability to work independently with supervision and as part of a team.
  • Strong sense of accountability and ownership of data quality and compliance.
  • Ability to identify, escalate, and document potential compliance or quality issues.
  • Ability to work in a fast-paced, deadline-driven laboratory environment while managing multiple priorities.

Nice To Haves

  • Hands-on experience with analytical instrumentation (e.g., HPLC, FTIR).
  • Experience working in a Quality Control laboratory supporting raw material or product testing.
  • Familiarity with laboratory systems such as chromatography data systems (e.g., Empower).

Responsibilities

  • Perform routine and non-routine analytical testing of raw materials in accordance with approved methods, specifications, and cGMP requirements.
  • Execute testing using techniques such as: HPLC, FTIR, wet chemistry, and an understanding of compendial methods (USP/EP).
  • Utilize laboratory systems such as Empower, or equivalent data management and chromatography systems, as applicable.
  • Document laboratory activities contemporaneously in compliance with cGMP and data integrity requirements, including ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available).
  • Review and evaluate analytical data for accuracy, completeness, and compliance; promptly communicate atypical results or trends.
  • Support laboratory investigations (e.g., OOS, Deviations, atypical results) by executing testing, documenting findings, and contributing to root cause analysis under supervision.
  • Perform peer review of laboratory documentation, as assigned.
  • Maintain a compliant, inspection-ready laboratory environment, including proper housekeeping and adherence to safety requirements.
  • Manage multiple samples and priorities in a deadline-driven environment to support timely raw material release.
  • Participate in team meetings, training programs, and continuous improvement initiatives.
  • Collaborate cross-functionally with Quality Assurance, Supply Chain, and other departments to support testing and release timelines.
  • Perform additional laboratory and quality-related duties as required to support business needs.

Benefits

  • Medical
  • Dental
  • Vision
  • STD
  • LTD
  • 401(k) Savings Retirement Plan
  • ESPP
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