Lab Technician

Description

This role is good for someone interested in microbiology, this job is not heavy on chemistry or analytical methods. This role is designed to be split between lab duties and autoclave sterilization requalification. The majority of the tasks of this role will be focused around the more entry level tasks such as pH, conductivity, anything that's related to their solutions, autoclaving, cleaning glassware The QA Analyst will conduct biological, chemical and physical testing on pharmaceutical products (biologics and drugs) and medical devices in a GMP lab through all stages of manufacturing process from incoming raw materials to finished goods and may include some environmental monitoring programs.

******** With this being a 8 month contract slated to end at the end of the year they will not get trained on all the rotations below, unless they catch on very quickly and can take on more responsibility. This position will consist of 3 rotations:

-AMEANS (running tests like spectrophotometer)
-AM phones (sterility reading, dye penetration tests) 6am-2:30pm is the shift. They are on the phones and picking up samples until noon, they will help around the lab as needed for the rest of their shift.

-Hood rotation (raw bioburden, water bioburden and ultrasonic bioburden testing)
* this position wont have as much lab work as other typical lab positions for the duration of the contract.

Essential Duties and Responsibilities:

Conduct critical biological, chemical and physical analyses such as raw materials, initial, in-process and final products, and samples collected from environmental monitoring programs at manufacturing facilities, etc. Use a variety of laboratory instrumentation and computer systems to collect and record data (such as LIMS system). Perform assays requiring precise analytical skills and understanding of biology and chemistry principles. Complete all testing, including special project / protocol testing in a timely and appropriate manner.

Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations. Write exception documents. Participate in functional efforts involving teams, which impact production, increase efficiency, solve problems, generate cost savings and improve quality. Perform laboratory and manufacturing audits as required. Audit and update, as required, plant SOPs. May perform equipment maintenance and calibrations as required A good amount of these tests are very routine and repetitive tests so must understand that going in.

To be successful, someone must have strong attention to detail.

Essential Duties and Responsibilities:

- Sets up test apparatus and conducts test on production processes and products to ensure methods, procedures, standards and sequence of operations are performed in compliance with all legal, regulatory and other relevant company policies.

- Conduct testing on materials and final products at manufacturing facilities. Document all testing and maintain complete quality records.

- Adjusts and calibrates production equipment as needed.

- Assists in the assessment and implementation of corrective actions and preventive to solve production quality issues.

- Modifies production equipment by adding, removing or altering components as defined by predetermined specifications.

- Corrects quality issues within the production process by making an adjustment or replacing manufacturing equipment parts or components.

- Participate in functions involving teams, which impact production, increase efficiency, solve problems, generate cost savings and improve quality - Monitors and verifies quality in accordance with statistical processes and other control procedures. The technician in this position is usually trained in on the 5 different rotations. (you stay on one rotation for the whole week) The more entry level instrumentations.

1. Phone p.m. (12:00 - 3:30), Seal Strength,ETO BIs, Sterility and PM Incubation, Hood and Touch Plate Review, Endotoxin, Media Sterility, Expiration review, Glassware Depyrogenation
2. Phone a.m. (6:00 - 12:00), Seal Strength, Sterility Reading, Release & Media Disposal , Weekly check of Dishwasher Detergent/Neutralizer, Dye Penetration, Gel pH and Viscosity, Hose Change, Dishwashing, Eye Wash and Safety Shower Check, Supply, Preparation and Autoclaving, Solutions 3. Raw Bioburden-BSC Cleaning, Material Transfer Certifications, Ultrasonic Bioburden, Gel Bis, Water Bioburden, Media Growth Promotion, Resuspensions,…