QC EM II role for Mon-Fri 8:30 am to 5:00 pm onsite 5 days/week
Position Summary: At Charles River Laboratories, we are looking for a highly motivated and energetic candidate to join our growing business in the CMO industry.
The QC Associate I will perform microbiological testing, static and dynamic viable and non-viable monitoring of classified clean room areas to support planned or in process manufacturing processes.
This position, as well as all positions in the Charles River team will require demonstration of Charles River DNA "Characteristics and Behaviors (Care, Lead, Own and Collaborate).
Key Responsibilities and Duties:
" Performs viable and non-viable environmental monitoring in a static and dynamic environment.
" Perform water quality analysis testing such as TOC and conductivity testing.
" Demonstrate excellent aseptic technique and clean room gowning practices required for working in Grade C, B and A spaces.
" Perform bioburden testing per current cGMP guidelines to facilitate in process product development and raw material release.
" Perform growth promotion, microbial identification, pure colony streak plate isolation, biological indicator testing in a controlled BSL2 environment.
" Complete relevant data entry requirements in accordance with current data integrity expectations and the ALCOA principals
" Assist in laboratory investigations, environmental monitoring excursions and deviations.
" Participate and facilitate on-going lab excellence initiatives as directed by the Senior QC Associate or area management.
" Work may be required outside of normal business hours.
" Additional duties as needed
Qualifications:
" B.S in Biology or related field
" 1-2 years working in a GMP facility is preferred, although not required.
" Able to lift up to 40 pounds
" Able to work in a clean room suite while wearing appropriate gowning and PPE FOR USE ONLY BY CRL ROCKVILLE EMPLOYEES AND OTHER AUTHORIZED PERSONS.
" Excellent verbal and written communication skills
" Ability to work independently or within a team setting
" Team-player
" Good organizational skills
" General computer skills including Microsoft Office software
" General lab skills or science background desired
| Enable Skills-Based Hiring | No | ||
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| No | ||
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| Helpful info: As far as skills go, all of these will be required but can be learned on the job, experience is always nice though: -Microsoft, word, excel etc -Understanding of cGMP principles and Data Integrity -Strong attention to detail, including accuracy of data input/record -Strict adherence to procedures -Aseptic Technique and Gowning Physical requirements: -able to lift ~40lbs (biohazard box removal/replacement, EM equipment, materials, etc.) -able to stand, walk, and perform repetitive actions (sampling) consistently and accurately -ability to work fully gowned in a cleanroom for 4-6 hours/day, de-gowning and re-gowning for a break is acceptable |
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| Onshore Only |
| Hours per Day | 8 |
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| Hours per Week | 40 |
| Total Hours | 640.00 |
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| Location | Rockville, MD |