QC Technician I: Molecular Diagnostic Products

Saco, ME
Full Time
Entry Level
QC Technician I: Molecular Diagnostic Products

EMPLOYER: Maine Molecular Quality Controls, Inc. (MMQCI), located in Saco, Maine, designs, develops, manufactures, and sells unique quality control products used by hospital laboratories and manufacturers to monitor the accuracy of tests for genetic, oncologic, and infectious diseases. MMQCI has patented technologies to stabilize DNA and RNA for use as quality controls and continues to pursue the discovery of novel techniques useful for the development of new quality control products. We are a small, growing company and offer a relaxed but challenging work environment.

POSITION TITLE: QC Technician I

GENERAL SUMMARY:
The successful candidate will enjoy performing a variety of tasks at a fast pace. QC Technician I supports Manufacturing and R&D by performing clinical and in-house assays for QC release of product, determination of product stability, regulatory studies, and environmental cleanliness.  The QC Technician will enter QC data into spreadsheets in the proper format to be analyzed.  A successful candidate is comfortable in a clean room laboratory environment where gowning and aseptic technique are required.  He or she enjoys being well-organized, performing detailed tasks according to established written Quality System procedures. It is expected that the QC Technician I will rapidly develop sufficient expertise to function independently with minimal supervision.

PRINCIPAL DUTIES AND RESPONSIBILITIES:
  • Perform clinical and in-house molecular diagnostic assays with strict adherence to written test procedures.
  • Support intermediate and final QC of product by performing testing according to specific product requirements, input data, and summarize results for review by Manager.
  • Perform clinical and in-house assays to assess stability of products, in-service testing, and support regulatory requirements as requested by strictly following established testing protocol.  Perform data input, analysis, summarize data, and present findings to Manager.
  • Assist with troubleshooting of assays.
  • May assist with assays related to environmental testing by performing data entry into spreadsheets, and graphing results.
  • Document all work with 100% accuracy in a timely manner by recording lot numbers, dates, etc. on documents required by MMQCI’s Quality System in accordance with current Good Manufacturing Practice (cGMP).
  • Carefully and consistently follows all MMQCI’s protocols to protect product integrity, including repetitive cleaning of benches, and donning of gloves, booties, lab coats, facemasks and hairnets and other Personal Protective Equipment as appropriate.
  • May be required to assist Manufacturing and R&D with other tasks as needed.  For example, aide in troubleshooting of product and assay / equipment validations.

MINIMUM KNOWLEDGE, SKILLS AND ABILITIES REQUIRED:
  1. B.S. in Biology / Life Sciences, with substantial appropriate laboratory coursework.
  2. Work experience in a laboratory setting is preferred.
  3. Familiarity with molecular biology (working with DNA / RNA) is highly desired.
  4. Ability to perform procedures quickly but with stringent accuracy and attention to detail.
  5. Good communication skills, written and oral, and strong computer skills, particularly Excel.
  6. Experience in a GMP or ISO quality system industrial environment is desired.
  7. Must be a nonsmoker due to product contamination prevention requirements.
  8. Must be able to stand for several hours and lift approximately 30 lbs.

The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification.  They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills of personnel so classified.



BENEFITS:
  • Medical insurance
  • Dental insurance
  • Vacation
  • Holidays
  • Sick leave
  • 401(k)
  • Profit Sharing Plan

How to apply: by Email/ No Phone inquiries accepted
Email:[email protected]

A cover letter is required Please!

Contact Information:
Human Resources
Maine Molecular Quality Controls, Inc.
23 Mill Brook Road
Saco,  Maine    04072
Fax:207-885-1079
Email:[email protected]

LOCATION: MMQCI is conveniently located in beautiful southern coastal Maine, minutes from the Maine Turnpike, Portland International Jetport, and less than 2 hours from Boston. Close by are fabulous Portland restaurants, sandy beaches, and a plentiful supply of Maine lobsters! Many terrific outdoor activities are easily accessible including hiking, biking, kayaking, fishing, skiing and snowshoeing. We have a beautiful, state-of-the-art facility located in Saco, right next to the Eastern Trail. Come join us!
 
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