QC Analyst II, Environmental Monitoring

Role Title                        QC Analyst II, Environmental Monitoring

Department                   Quality  

Supervisor                      Sr. QC Manager    

FLSA                               Exempt

CORE VALUES 

Respect ● Passion ● Teamwork ● Integrity ● Honesty ● Commitment ● Collaboration

FUNCTION SUMMARY      QC Analyst II, Environmental Monitoring

The EM Quality Control Analyst II, under direct or minimal supervision, is responsible for environmental monitoring as well as performing analytical analysis of samples compliant with cGMP guidelines. The Analyst works independently on assays that they have mastered. This position requires willingness to undergo training on more advanced analytical methods and always employs laboratory safety policies. The Analyst will be responsible for the timely completion of assignments. Good record keeping, organizational, written, and verbal communication skills are essential. The analyst must be willing to work overtime as required.

Duties & Responsibilities:

1. Perform routine environmental and utility sampling and testing of cGMP areas.
2. In addition to environmental monitoring, performs analytical analyses of utility test samples under cGMP to meet specified timelines.
3. Evaluates data against defined criteria/specifications.
4. Identify and support OOS/OOE/OOT investigations.
5. Maintains the laboratory in an inspection-ready state.
6. Performs routine laboratory functions/chores for the QC laboratory.
7. Responsible for assisting in the revision of written procedures as assigned.
8. Develops and maintains proficiency in a broad range of trained test methods.
9. Holds self and others responsible to abide by department and company policies and practices.
10. Develops familiarity concerning cGMP, 21CFR, USP, EP, ICH, and other applicable regulatory requirements as required.
11. Manage reagent and equipment inventory for assigned areas of responsibilities.

Skills & Competencies

• Performs tasks associated with maintaining cGMP compliant Quality Control and Stability laboratories. Ability to follow written instructions and to perform tasks with direct or minimal supervision. Works independently as well as in a team environment. Familiarity with use of a computer: e.g., Proficient in Windows, Microsoft Word, Excel. Good written and verbal communication skills. Strong documentation skills a must. The analyst must develop skills in the operation and routine maintenance of various analytical instruments and computers.

Experience with GMP and environmental monitoring and analysis preferred. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities by this job include close vision, depth perception, and ability to adjust focus.

Education & Experience

• B. S./B. A. in Science/Related Field (major in biology-biochemistry-chemistry). 2-5 years of relevant laboratory experience is desired.