Quality Control Chemist II
Key responsibilities to include the following.
· Work hands-on with HPLC, GC, IC, KF and other routine analytical equipment such as pH meter and balance.
· Method development and method validation, including writing protocols and reports. Must be proficient.
· Responsible for reviewing analytical laboratory records.
· Participate in out of specification (OOS) investigations, as well as other investigations, and writing investigation reports.
· Perform and review QC stability and release testing.
· Maintain the QC lab by ordering supplies routinely used for testing.
· Assist the QC/QA group with writing and editing of SOPs and STPs.
· Support OQ/PQ for the Quality Control equipment; troubleshoot equipment.
· Train and oversee junior chemists for routine QC activities.
· Other duties as assigned.
The successful candidate will possess the following.
§ Master’s Degree in Chemistry or life sciences with 2-5 years of experience in a GMP environment, or Bachelor’s Degree in Chemistry or life sciences with 5-7 years of experience in a GMP environment.
§ Hands-on experience with HPLC/UPLC, GC, GC-MS/LC-MS, KF, IC.
§ Experience with MassLynx is desirable.
§ Hands-on experience with Empower and/or Chemstation is required.
§ Familiarity with both CFR 21 and ICH guidelines in regard to GMP.
§ Computer skills in MS Word, EXCEL, and Access.
§ Effective communication skills (oral and written).
§ Flexibility in working hours is required.
§ Supervisory experience is preferred.
§ Must be able to sit and stand throughout the day.
§ Must be able to lift a min. of 30 pounds at any given time throughout the day.
§ Must be able to wear a respirator in the lab areas as needed.
Product Quality Assurance
Code Of Federal Regulations