About this role
Performs routine testing of raw materials, cleaning samples, bulk intermediate and finished product, and/or stability samples, according to established regulatory protocols and procedures. Employee will be trained and become proficient in intermediate preparation techniques and analysis methods. Core hours are Sunday through Thursday, 7:00 am to 3:30 pm, with training hours that may vary.
Conducts analyses on various samples, maintains instrumentation, and documents all activities per good documentation practices. Performs intermediate method transfers and provides detailed accounts of testing to investigators. Under supervision, assists with investigational testing.
Trains junior analysts in methods and techniques at management's direction. Maintains an atmosphere of teamwork, cordiality, and respect, assisting co-workers as needed. Interacts respectfully with employees across departments and resolves differences appropriately.
Makes scientific recommendations to management on QC procedures and supports continuous improvement efforts. Identifies issues and escalates to leadership. Generates ideas for efficiencies and willingly adopts process enhancements.
Requirements
- Knowledge of a government regulated laboratory environment including cGMP, GLP and ICH
- Intermediate understanding of the use of USP, NF and other compendia
- Ability to use and maintain analytical laboratory instruments such as HPLC, FTIR, GPC, GC, and UV-Vis spectrophotometers
- Effective written and oral communication skills
- Knowledge of computer systems for sample tracking
Responsibilities
- Perform analyses on a variety of samples using intermediate preparation techniques and analysis methods
- Train junior analysts in analysis methods and lab techniques
- Document all activities and maintain records according to good documentation practices
- Ensure proper use, care and maintenance of instrumentation
- Perform intermediate method transfers
- Provide detailed accounts of testing performed to investigators and assist with investigational testing under supervision
- Make scientific recommendations to management regarding QC procedures
- Identify issues and escalate to department leadership as appropriate
Similar roles

GMP/Cleanroom Cleaner
1w1 week agoABM Industries
Plainfield, US · Part-time · $32,000 – $42,000

Project Manager
1w1 week agoQRC Group
Canovanas, PR · Full-time · $85,000 – $125,000

Executive Associate - Fill Finish Facility
1w1 week agoLupin
Pune, IN · Full-time · INR 300,000 – INR 450,000

Quality Control Chemist
1w1 week agoGrifols
Los Angeles, US · Full-time · $52,000 – $56,000
