This job was posted by https://illinoisjoblink.illinois.gov : For more
information, please see:
https://illinoisjoblink.illinois.gov/jobs/11885848
For further inquiries regarding the following opportunity, please
contact one of our Talent Specialist
Meghna \| 224 369 4230 /mparwar@divihn.com
Title:Quality Associate II
Duration:6 months
Location:Round Lake, IL
Description:
Summary:\
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Ensure quality assurance oversight and compliance to approved policies
and regulations on laboratory computerized systems and instruments that
conduct biological, chemical, and physical analyses on pharmaceutical
products through all stages of the manufacturing process from incoming
raw materials to finished goods, and environmental monitoring programs.\
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Must not be allergic to Penicillin or Cephalosporin drugs.\
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Essential Duties and Responsibilities:\
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Perform administrator functions and maintain user access to laboratory
computerized systems and instruments.\
Coordinates training with laboratory personnel for computerized systems
and instrumentation after updates and enhancements.\
Understand and maintain knowledge of sophisticated laboratory
instrumentation and computer systems used to collect and record data.
Understand and maintain knowledge of advanced laboratory assays
requiring precise analytical skills and understanding of scientific
principles.\
Be a Subject Matter Expert (SME) on computerized systems and equipment
and know how to troubleshoot issues with laboratory staff.\
Act as a liaison between instrument/plant engineers, IT personnel,
validation, and laboratory staff for instrument / system operation.\
Provide input and/or review validation protocols related to laboratory
instrument and computerized systems. Assess impact of changes to
computerized systems and laboratory instruments.\
Support projects that involves enhancements or updates to computerized
systems or new methods which require instrumentation or systems updates
to computerized systems. Complete all activities in a timely and
appropriate manner.\
Maintain data integrity and ensure compliance with company SOPs and
specifications, FDA, GLP, QSR and cGMP regulations. Investigate
nonconformance events and write exception documents.\
Participate in functions involving teams, which impact production,
increase efficiency, solve problems, generate cost savings, improve
quality, and provide new product support.\
Coordinate with laboratory staff to perform periodic review and
laboratory audits. Provide support to audit and update instrument and
computerized systems SOPs as required.\
Present information and/or respond to questions during compliance
audits.\
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Qualifications:\
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Prior experience with laboratory information management systems and/or
laboratory instrumentation is required.\
Experience with BaxLIMS, Empower CDS, LabVantage, Electronic Lab
Notebook (ELN), Bacterial Endotoxin Readers, highly desired.\
Strong knowledge of FDA, ISO and GMP regulations.\
Ability to communicate between various levels of engineering,
validation, IT, and laboratory personnel.\
Ability to handle multiple tasks concurrently, and in a timely fashion.
Occasional off-shift or weekend work may be required.\
Must be able to communicate effectively with managers, peers, and
subordinates.\
Strong leadership, organization and time management skills, and ability
to manage multiple tasks.\
Must demonstrate effectiveness in ability to train others, empowerment,
results oriented and task completion.\
Strong Decision-making and technical problem-solving skills.\
Physical demands of the position may require the ability to lift
materials or equipment up to 50 lbs. and wear personal protective
equipment.\
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Education and/or Experience:\
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Bachelor\'s Degree in Science (Chemistry or Biological science) or
technical field (Information Technology or Engineering) with 5 or ore
years experience, or Master\'s Degree with 2 or more years experience.