Associate Manager, Quality Control – Quality Assurance & Compliance Department

 

This position will manage the Quality Control functions including raw material receipt, sampling, coordinating testing, reviewing data, preparing complete documentation, and training of staff. The incumbent will ensure that their responsible functions are GMP and GLP compliant with the regulated pharmaceutical requirements. Responsibilities will include: supervision of degreed staff, familiarity with the manufacturing operations, knowledge of the requirements of the document management system, participation in the GMP/GLP training programs, support of internal audits and reporting of findings to management, contributions to quality system improvements, conducting and contributing to OOS and deviation investigations, maintaining the environmental monitoring program, participating in client and regulatory audit/inspections, effective communication with departments, and ensuring timeliness, accuracy and integrity of the work product. The position will require keeping current with international compendia regulations.  
 
The position requires experience supervising staff, a working knowledge of GMP/GLP and quality systems, working knowledge of various analytical and microbiology methodologies, effective communication skills, team work, problem solving skills, good judgment, excellent writing skills, attention to detail, organization skills, and ability to multitask and meet demanding timelines. The position requires fluency with Microsoft Office software.  
 
A minimum of a Bachelor?s degree in a scientific or life sciences field with at least seven years working experience in the pharmaceutical industry including a minimum of five years in a quality area or equivalent experience or a Masters degree in Chemistry, Biology, or Health Sciences with a good working knowledge of pharmaceutical GMP/GLP and at least five years in a quality function. Salary is $65-85K DOE. Contact Elena Herdman at (707) 521-2140 or email elenah@certifiedemployment.com