Quality Control Chemist II / III

10/13/20

Augusta, GA 29841

1069

FullTimeRegular

QUALITY CONTROL CHEMIST II / III – Pharmaceutical Development and Manufacturing Facility.

Our client is located in the Southeast US and is a global leader in developing and manufacturing a niche complex injectable for both drug substance and drug products. They are coming off a $20million capital investment project which is already paying off dividends for the company as they continue to forge and develop new business deals for developing new drug products across many different types of therapeutic areas.

RESPONSIBILITIES

  • 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.

QUALIFICATIONS

  • 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 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.

Benefits:

Competitive salary and bonus, relocation assistance, medical, dental, vision, 401k, very affordable location with reasonable housing prices and good schools.

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