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Job Req ID:  9730

QA/QC Technologist

General summary/purpose:

 

The Clinical Pharmacology Analytical Laboratory (CPAL) focuses on the development and implementation of high-throughput liquid chromatographic-tandem mass spectrometric (LC-MS/MS) methods for the identification and quantitative analyses of small molecules. Clinical research specimens are analyzed based on Assay Validation Reports and Standardized Operating Procedures (AVR/SOP) that are reviewed and approved by the cross-network NIH/DAIDS external Clinical Pharmacology Quality Assurance Program. Using knowledge of current accrediting and regulatory requirements, this position will be part of the CPAL’s Quality Assurance Unit, ensuring that laboratory programs are in compliance with such requirements.

 

Specific duties & responsibilities:

 

The person in this position must:

 

  • Be familiar with regulatory requirements required for translational and clinical research.
  • Review and monitor the documentation practices and data recording quality of all analytical runs generated in the laboratory.
  • Assist in the implementation and monitoring of appropriate QA/QC of the total testing process within the CPAL, including pre-analytical functions (specimen labeling, processing) analytical functions (testing), and post analytical functions (test reporting, specimen storage/shipping).
  • Ensure that protocol related tests have been validated and the appropriate validations are readily available. 
  • Will interact with sponsors and collaborators when they are on site
  • Work with lab management to ensure adequate inventory
  • Assist with training of technologists in specific test procedures or QA procedures to be used in protocol testing.

 

Essential Job Functions:

 

  • Experience using universal safety precautions to protect self and co-workers.
  • Able to follow and adhere to existing Standard Operating Procedures (SOP).
  • Able to adhere to schedules and protocols.
  • Assist in drafting or revising SOPs.
  • Must be able to communicate with others in the lab, to seek help, make suggestions and express ideas as necessary.
  • Proficiency working with computers and various software applications, especially Microsoft Excel and Microsoft Word, the World Wide Web and electronic mail.
  • Complete annual university biohazard/universal precaution/radiation safety training.
  • Adhere to biohazard/radiation safety standards for the proper handling and disposal of potentially hazardous chemical and biological agents and/or radiation sources in the workplace.
  • Able to work as part of a research team.
  • Must be able to take responsibility for completing tasks within specified timeframes.

 

Scope of Responsibility

 

  • Will have knowledge of the policies, procedures and practices necessary to conduct the work described above and an awareness of the role and importance of the position within the CPAL its potential impact on the working unit.
  • Will be responsible for one’s own work.

 

Decision Making

 

  • Exercise professional judgment and assume responsibility for own decisions, actions, results and consequences.

 

Authority

  • Reports to the International QA/QC Coordinator or the Director of the CPAL.
  • Will be responsible for one’s own work.

 

Communication

 

  • The person in this position will be expected to exchange complex and detailed information in an appropriate manner requiring strong oral and written communication skills.
  • The person in this position must be willing to seek guidance in a timely fashion when uncertain regarding duties or assignments.

 

Qualifications:

 

  • Required: A minimum of BS/BA in biochemistry, analytical chemistry, chemistry, molecular biology or comparable biological or physical science area. 

 

Knowledge, Skills, and Abilities:

 

 Preferred Experience

 

  • Previous experience (>1 year) in an official QA or QC role is highly preferred.
  • 1-2 years of experience in a GLP-regulated laboratory environment, and experience as a participant in a quality assurance program.
  • Familiarity with mass spectrometry or HPLC is preferred, but not required.
  • Proficiency working with computers and various software applications, especially Microsoft Excel and Microsoft Word, the World Wide Web and electronic mail.

 

Physical Requirements

 

  • Work produced is subject to precise measures of quantity and quality.
  • Work environment may include areas of unpleasant extremes of odor and temperature (cold or heat).
  • Biohazardous conditions such as the risk of radiation exposure, fumes or airborne particles, and/or toxic or caustic chemicals or infectious agents such as HIV may be present in this work environment and mandate attention to safety considerations.
  • Near vision to see objects clearly within 20 inches.
  • Sharp focus to adjust vision when doing close work that changes in distance from eyes.
  • Full spectrum vision to identify and distinguish color.
  • Finger dexterity required to manipulate objects with fingers rather than with whole hand(s) or arm(s), for example, using a keyboard.
  • Handling by seizing, holding, grasping, turning or otherwise working with the hand or hands, but without finger dexterity.
  • Occasionally lifting, carrying objects weighing 20 lbs. or less.

 

Classified title:  Research Specialist

Working title: Quality Assurance/Quality Control Technologist

Role/Level/Range: ACRP/3/MA

Starting Salary Range: $32,562 - $44,742 (commensurate with experience)

Employee group: Full-Time

Employee subgroup:  Non-Exempt

Schedule: Working 40 hours per week; Monday-Friday 8:30-5pm plus

Location:  Johns Hopkins East Baltimore

 

 

The successful candidate(s) for this position will be subject to a pre-employment background check.

 

If you are interested in applying for employment with The Johns Hopkins University and require special assistance or accommodation during any part of the pre-employment process, please contact the HR Business Services Office at jhurecruitment@jhu.edu. For TTY users, call via Maryland Relay or dial 711.

 

The following additional provisions may apply depending on which campus you will work.  Your recruiter will advise accordingly.

 

During the Influenza ("the flu") season, as a condition of employment, The Johns Hopkins Institutions require all employees who provide ongoing services to patients or work in patient care or clinical care areas to have an annual influenza vaccination or possess an approved medical or religious exception. Failure to meet this requirement may result in termination of employment.

 

The pre-employment physical for positions in clinical areas, laboratories, working with research subjects, or involving community contact requires documentation of immune status against Rubella (German measles), Rubeola (Measles), Mumps, Varicella (chickenpox), Hepatitis B and documentation of having received the Tdap (Tetanus, diphtheria, pertussis) vaccination. This may include documentation of having two (2) MMR vaccines; two (2) Varicella vaccines; or antibody status to these diseases from laboratory testing. Blood tests for immunities to these diseases are ordinarily included in the pre-employment physical exam except for those employees who provide results of blood tests or immunization documentation from their own health care providers. Any vaccinations required for these diseases will be given at no cost in our Occupational Health office.

 

Equal Opportunity Employer
Note: Job Postings are updated daily and remain online until filled. 

 

EEO is the Law
Learn more:
https://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf
Important legal information
http://hrnt.jhu.edu/legal.cfm

 

School of Medicine - East Baltimore Campus

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