Quality Control Chemist II
- 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.
- 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.
- Hands-on experience with Empower and/or Chemstation. Experience with MassLynx is desirable.
- 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 lift a min. of 30 pounds at any given time throughout the day.
Must be able to sit and stand throughout the day.
- Must be able to wear safety shoes & glasses through-out the day while in the designated areas, (provided by the company)
- You must be cleared by a physician to wear a respirator throughout the day while in designated areas.
- Must be ok working in a chemical environment.