Quality Control Associate - Microbiology Lab

BASIC SUMMARY: 

Review raw analytical data and assess the technical content to ensure the data is error free prior to final quality assurance review.  Provide guidance and assist when necessary in responding to queries from internal and external audits.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES: 

· Assist technicians and research associates in all phases of data collection and finalization. 

· Assist supervisory personnel with daily raw data review.

· Assist Principle Investigators in preparing data for final report.

· Ensure all protocol requirements have been met.

· Ensure all procedures have been performed and documented per protocols and SOPS.

· Assist in training technicians in proper procedural and protocol adherence and data collection.

· Train study personnel in data review, correction, and quality control procedures.  

· Respond to inquiries on quality control procedures and technical procedures in general.

· Assist in answering of internal/external QA audits; assist in training technical staff to answer audits.

· Work with technical staff to identify and resolve all issues that may result in a non-conformance or atypical issue.

· Assist in the development of Quality Control SOP’s and guidance documents for technical personnel.

· Assist in developing methods to reduce errors and in the development of quality principles to instill a quality focused mind set.

· Prepare Supervisors for sponsor site visits. 

· Prepare data for Client visits/review. 

· Assist in special projects, as needed.

· Assist in identifying training issues, including the development of the first level quality checks.

· Provide research associates with recommendations for technician review regarding technical skills, data recording, and management

· Assist in identifying performance issues with data supplied by operators to ensure proper compliance with SOPs.

· Perform all other related duties as assigned.

 

QUALIFICATIONS:

· Education:. Bachelor’s degree (B.A./B.S.) or equivalent in a Biology, Chemistry, Virology, Microbiology or Biochemistry. 

· Experience: One to three years experience in Laboratory Operations, Quality Assurance or Technical Services with a minimum of 1 year analytical experience in a GMP regulated environment.

· An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.

· Certification/Licensure:  None.