Associate Scientist II, Quality Control

Role Summary

An Associate Scientist II, Quality Control supports analytical testing activities across environmental monitoring, raw materials, in-process samples, finished drug substances and drug products, and stability samples. The role also supports GLP Toxicology and cGMP Clinical Trial material release testing, and requires performing several analytical techniques with guidance from management.

Responsibilities

• Develop understanding of cGMP requirements.
• Meet project timelines and deliverables with guidance from laboratory leadership.
• Perform routine analytical testing of pharmaceutical materials and products using established methods.
• Complete training per SOPs and procedural guides; maintain up-to-date training records.
• Operate and gain proficiency with analytical instrumentation (e.g., HPLC, GC, FT-IR, UV/Vis, KF).
• Set up instrumentation for testing per written methods with minimal supervision.
• Plan and execute tasks with minimal supervision; perform analyses in a timely manner.
• Collaborate with team members; demonstrate initiative to learn new techniques.
• Identify and troubleshoot minor analytical problems; communicate issues to senior staff.
• Maintain clear, concise laboratory notebook/records; review data as applicable.
• Aid in drafting technical documents such as OOS/atypical investigations, deviations, and CAPAs.
• Demonstrate strong written and verbal communication; analyze data and propose follow-up with supervision.
• Adhere to cGMP requirements and work cooperatively in a team; maintain attention to detail.
• Calibrate, maintain, and troubleshoot analytical equipment with supervision; adapt to changing priorities.

Qualifications

• Required: B.S. in Chemistry (or related field) with 1‚Äì3 years of relevant laboratory experience.
• Required: Experience with cGMP laboratory requirements and operations.
• Required: Familiarity with analytical instrumentation, test methodologies/validations, data acquisition systems, and cGMP policies and practices.
• Preferred: Experience with GLP/Toxicology testing and stability studies.

Skills

• Analytical instrumentation (HPLC, GC, FT-IR, UV/Vis, KF)
• Laboratory recordkeeping and data analysis
• Technical documentation and CAPA/oos investigations
• Team collaboration and communication

Education

• B.S. in Chemistry or related field (as listed in Qualifications)

Additional Requirements

• Authorization to work in the US