Ref No.: 15-00377
Location: Rochester, Michigan
Start Date / End Date: 03/16/2015 to 12/13/2015
JobTitle Description:
SUMMARY: The Penicillin Laboratory is a combination laboratory including both Chemical and Microbial testing in a Penicillin facility. The analyst is expected to learn and perform routine chemical quality control testing of pharmaceutical products and related materials in accordance with site policies, departmental procedures, compendial methods, and cGMP regulations. Participates in transfer of methods, validations, investigations, team projects, and special studies to accomplish company and departmental goals. Records and reports data accurately and in compliance with current methods/SOPs, USP/NF, other compendia as applicable, and cGMP.

  • Learns to and performs routine chemical testing of raw material, in-process, residuals, finished product and stability samples following approved specifications, and Standard Operating Procedures (SOPs). This may include but is not limited to pH testing, IR testing, HPLC and GC testing, TOC and water testing, viscosity, TLC and wet chemistry testing.
  • Learns to, and performs set up, calibration, operation, and maintenance of laboratory test equipment.
  • Learns to and completes testing with a high degree of efficiency, reliability, and accuracy.
  • earns to and logs samples received into the laboratory and assess their integrity upon receival.
  • Performs assigned work in timely and safe manner conforming to regulatory, company and compendial requirements.
  • Records and reports test data correctly, completely and accurately within company and departmental policies and guidelines.
  • Notifies supervision of unusual results for evaluation.
  • Actively assumes and demonstrates responsibility in learning practical laboratory skills, and a thorough knowledge of chemical theories, analytical methodologies and procedures.
  • Acquires knowledge and understanding of company and departmental policies pertaining to cGMP, cGLP, safety, health, security, and departmental operation.
  • Complies with company and departmental regulations, policies and guidelines in performance of the job.
  • Recognizes problems within scope of job and promptly and clearly communicates them to supervision.
  • Follows directions and demonstrates proper judgement when a deviation occurs.
  • Initiates Laboratory Investigations (LIR) and Manufacturing Investigations (MIR).
  • Reviews OOS and unusual test/equipment data with management or senior staff and completes LIRs and MIRs under the direction of management and advisement of senior staff members.
  • Learns to and recognizes trends, deviations, problems and promptly reports them to laboratory management.
  • Follows directions and demonstrates proper judgment when a deviation occurs. Participates in inventory control.
  • Maintains a neat and orderly workspace, adhering to all laboratory disinfection policies.
  • Assists in reviewing and editing SOPs, analytical methods and procedures.
  • Writes clear, accurate and concise technical and non-technical documents.
  • Performs routine verification of laboratory standards, solutions and documentation. Prepares solutions and standardizes test solutions when applicable.
  • Employee must not be allergic to Penicillin.
  • Bachelors Degree in Chemistry, Microbiology or related science field and 2-4 years related experience; or an equivalent combination of education and experience/training
Analytical Accurately performs testing, precisely documents data, and analyzes information skillfully; thorough knowledge of laboratory techniques and safety procedures.
  • Technical Skills: Proficient in use of standard laboratory equipment, and able to run complex analytical assays; ability to apply mathematical and statistical concepts.
  • Math Ability: Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals; compute rate, ratio, and percent and to draw and interpret graphs.
  • Reasoning Ability: Ability to define problems, collect data, establish facts, and draw valid conclusions; interpret an extensive variety of technical instruction in mathematical or diagram form and deal with several abstract and concrete variables.
  • Computer Skills: To perform this job successfully, an individual must have or be able to acquire knowledge of Microsoft software such as Word, Excel, Access and other company and laboratory computer applications
  • This position is in a Penicillin facility. The employee must not be allergic to Penicillin, and will be required to undergo Penicillin allergy testing.
  • There are garb requirements that must be adhered to since it is a Penicillin facility.
  • While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts.
  • While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to finger handle or feel; reach with hands & arms; talk and/or hear.
  • The employee must occasionally lift and/or move up to 25 or more pounds.
  • Specific vision abilities required by this job include close, distance, color and peripheral vision.
  • In addition, the individual should have good depth perception and the ability to adjust focus.