Manufacturing Technician II: Molecular Diagnostics Products

MMQCI's level II Manufacturing technicians use their molecular biology skills to carefully and precisely prepare materials for and perform final manufacturing of molecular based diagnostic controls.
*Manufacturing Technician II: Molecular Diagnostics Products* EMPLOYER: Maine Molecular Quality Controls, Inc.
(MMQCI), located in Saco, Maine, designs, develops, manufactures, and markets unique quality control products used by hospital laboratories to monitor the accuracy of tests for inherited disease, pharmacogenetics, oncology, and infectious diseases.
MMQCI also provides custom products to IVD manufacturers for test development, internal QC and kit controls.
MMQCI has developed 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 that offers a relaxed but challenging work environment with opportunities to gain experience using the latest molecular biology tools.
POSITION TITLE: Manufacturing Technician II *GENERAL SUMMARY:* The Manufacturing Technologist II precisely and reproducibly manufactures and tests products according to established, detailed written procedures under limited supervision by the Manager of Manufacturing Operations.
The successful candidate has a strong molecular biology background and is experienced in the manufacture of _in vitro_ laboratory diagnostic products according to Good Manufacturing Practice (GMP) and/ or ISO 13485.
The successful candidate has excellent laboratory dexterity, is well-organized and enjoys detailed work.
The Manufacturing Technologist II will also be required to assist with troubleshooting clinical laboratory test systems, and product modifications and improvements.
*PRINCIPAL DUTIES AND RESPONSIBILITIES:* 1.
Accurately and reproducibly manufactures MMQCI products by following detailed, multi-step procedures (SOPs) exactly as written.
Precise delivery of small volumes using micropipettes is required, as well as handling of large glassware.
2.
Follows MMQCI’s protocols based on current Good Manufacturing Practice (cGMP) and International Organization for Standards (ISO) 13485 regulations by consistently and accurately filling out appropriate paperwork and adhering to established procedures.
3.
Prepares, quantifies and manipulates DNA and RNA and other product components.
4.
Assembles final bulk products using a variety of measurement tools and in-process tests.
5.
Is comfortable working in a clean room laboratory environment where stringent adherence to gowning and aseptic techniques are required.
6.
Assists with equipment validation, calibration and maintenance, as well as environmental testing as needed.
7.
Participates in modifying/ improving existing MMQCI products and processes.
8.
Fills and labels products as needed.
9.
Contributes to general laboratory support functions, including maintenance of clean room work areas and general laboratory housekeeping duties.
*MINIMUM KNOWLEDGE, SKILLS AND ABILITIES REQUIRED:* * B.
A.
or B.
S.
in biology/ Life Sciences, and at least 3 years of experience in manufacturing molecular products, or similar biotech products under cGMP or ISO 13485 regulations.
* Experience with molecular biology techniques including DNA extraction, plasmid purification, amplification by PCR, and gel electrophoresis is required.
* Ability to perform laboratory procedures quickly but with stringent attention to detail.
* Is well organized and enjoys precise, detailed work.
* Good communication skills, written and oral, with excellent computer skills including Excel.
* Experience in a GMP or ISO quality system biotech environment is required.
* Ability to handle the pressure of meeting tight deadlines and dynamic work conditions.
* Ability to work independently with minimal supervision.
* Must be a nonsmoker due to product contamination prevention requirements.
* Must be able to stand for several hours, lift approximately 25 lbs and manipulate large glass flasks.
_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 * 401(k) * Profit sharing plan * Vacation * Holidays * Sick leave *How to apply*: by Email/ No Phone inquiries accepted _*A cover letter is required.
*_ Contact Information: Human Resources Maine Molecular Quality Controls, Inc.
23 Mill Brook Road Mill Brook Business Park Saco, Maine 04072 _*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 are in a brand new state-of-the-art facility in Saco, Maine, right next to the Eastern Trail.
Come join us! Job Type: Full-time Benefits: * 401(k) * Dental insurance * Health insurance * Paid time off Schedule: * Monday to Friday Application Question(s): * This position requires a cover letter prior to setting up a phone introduction.
Have you attached a cover letter? Education: * Bachelor's (Required) Experience: * Biotech Manufacturing: 3 years (Required) Work Location: In person