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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 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.
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 6 different rotations. The more entry level instrumentations.
-AMEANS (running tests like spectrophotometer)
-AM phones (sterility reading, dye penetration tests)
-PM phones (getting production calls, endotoxin testing)
-Hood rotation (raw bioburden, water bioburden and ultrasonic bioburden testing)
-EM (environmental monitoring in the clean room, reading the results and entering in the data into the LIMS)
-Solutions (pH, conductivity, anything that's related to their solutions, autoclaving, cleaning glassware)
Additional Skills & Qualifications:
Requirements
- BS/BA in Microbiology, Biology or Chemistry or like field
- Must have an understanding of aseptic techniques, or biological testing (college courses are fine).
- Attention to detail, with ability to keep detailed notes and logs.
- Micro tests knowledge to understand what we are testing for: endotoxin testing, aseptic techniques, bio-burden testing, sterility testing
-Knowledge of basic laboratory and pharmaceutical production equipment including but not limited to: autoclaves, process tanks, incubators, analytical equipment, and CIP/SIP systems.
-proven ability to navigate computer systems including Word, Excel, etc
Nice to have- cGMP knowledge
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