QC Analyst II

1w1 week ago

Tolmar

Fort Collins, US · Full-time · $72,000 – $74,000

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. Core hours are Sunday - Thursday, 3:00 pm - 11:30 pm, with training hours that may vary. Employee will be trained and become proficient in intermediate preparation techniques and analysis methods.

Perform analyses on a variety of samples using intermediate preparation techniques and analysis methods. Accountable for documenting all activities and maintaining records according to good documentation practices. Perform intermediate method transfers and provide detailed accounts of testing performed to investigators.

Prioritizes tasks and performs job duties with minimal guidance from management. Accountable for maintaining an atmosphere of teamwork, cordiality and respect towards co-workers. Interacts respectfully with all other employees both inside and outside of the department.

At the direction of management, train junior analysts in analysis methods and lab techniques. Make scientific recommendations to management/technical writers regarding QC procedures. Provide support to the department leadership with the implementation of new systems, and continuous improvement efforts.

Requirements

Knowledge of a government regulated laboratory environment, preferably for drugs or medical devices 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
Follow company and regulatory data integrity guidelines
Participate in required annual hazardous waste training and respond to spills per Chemical Spill Procedures

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 perform investigational testing under supervision
Make scientific recommendations to management/technical writers regarding QC procedures
Identify issues and escalate to department senior leadership or management as appropriate