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MTF Laboratory Analyst I in Jessup, Pennsylvania

Overview/Risks

Responsible for ensuring that test method execution is performed in accordance to validated MTF procedures and regulatory standards set forth by AATB, FDA, TGA, and USP.All operational procedures are performed to ensure customer service between contract laboratories and departments within MTF.

The Laboratory Analyst I will provide support to the team leader(s), laboratory supervisor(s), and manager(s) in the qualification, implementation, and continuation of test methods.

Responsibilities

  1. Responsible for performing test methods following laboratory systems of operation, current Good Laboratory Practices (cGLPs), current Good Manufacturing Practices (cGMPs) as well as current and approved laboratory operating procedures (OPs) and work instructions (WIs).

  2. Performs laboratory assays, microbiological, physical and analytical testing as designated.

  3. Reconciles all samples and maintains chain-of-custody documentation according to MTF documentation procedures.

  4. Performs data review for sample throughput daily.

  5. Annually reviews all OPs and WIs in Master Control for necessary testing and analyses.

  6. Performs monthly calibrations on micro liter pipettes and/or thermometers.

  7. Routinely operates and troubleshoots equipment, instruments and associated software.

  8. Ensures test methods are performed within sample hold times.

  9. Responsible for monitoring temperatures of laboratory incubators, freezers, refrigerators, water baths, ovens, etc.

  10. Maintains calibration records for the lab and instrumentation as required.

  11. Maintains proficiency and certification for all test methods that training has been completed.

  12. Performs data entry functions using the LIMS (Laboratory Information Management System), QDDS, and the MTF email system as assigned.

  13. Interfaces with QA, QE, laboratory management or team leaders for review and interpretation of test results.

  14. Responsible for the cleaning and removal of biohazard waste and inventory within the laboratory.

  15. Actively cooperates in training and retraining due to operation changes and/or document updates as required.

  16. Performs additional duties as assigned and trained

Qualifications

MINIMUM JOB REQUIREMENTS

Education:

B.S. in biology, microbiology, chemistry, or related science field required.

Experience:

1 year experience in academic, clinical or industrial laboratory setting.

Specific Licenses and/or Certifications:

Must possess valid driver’s license

Specialized Knowledge, Skill, and Abilities:

· Strong analytical technique relating to laboratory settings.

· Proficient in aseptic technique in general laboratory setting.

· Proficient in Microsoft Office and Microsoft Outlook.

· Strong communication and organization skills and the ability to work independently as well as within a team environment.

Work Environment:

· Laboratory

· Weekends, holidays and overtime may be required

Physical Demands:

( if applicable)

· Must be able to lift 50 pounds.

· Must be able to read very small print, count small colony forming units on agar plates, or identify mixed slide cultures in a light microscope.

· Must be able to drive long distance for meetings.

· Must be able to stand for long periods of time and work for up to four hours without a rest break.

· Works with potential biological hazardous material.

PREFERRED QUALIFICATIONS

Education:

NA

Experience:

· 3 years experience in academic, clinical or industrial laboratory setting.

· 1 year experience with LIMS database.

· 1 year experience with micro liter, multichannel, serological, and repeater pipettes.

Specific Licenses and/or Certifications:

NA

Specialized Knowledge, Skill, and Abilities:

· Knowledge of GLPs/GMPs, statistical calculations, FDA regulations, Standard Operating Procedures (SOPs), and USP methods required.

· Proficient in aseptic technique in general laboratory setting, as well as fume hood and biological safety cabinets (BSCs).

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Job Location US-PA-Jessup

Type Full-Time

Category Quality

Shift 1st Shift

Job ID 2021-5235

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