What are the responsibilities and job description for the Quality Lab Associate II position at DivIHN Integration Inc?
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Sony | (630) 847 1417
Pratichi | (630) 847 0267
Title: Quality Lab Associate II
Duration: 6 Months
Location: Round Lake, IL
Hours: 3rd shift: 10 PM to 8:30 AM
Summary
Job Description
Conduct critical chemical and physical analyses on Raw Materials, Initial, In-process and Final products, and samples collected from environmental monitoring programs at client manufacturing facilities. Work under minimum supervision.
Review and approve laboratory data to release batches and/or raw material for use.
Use sophisticated laboratory instrumentation (HPLC, FTIR, UV, GC etc) and computer systems to collect and record data.
Perform advanced assays requiring precise analytical skills and understanding of biology and chemistry principles.
Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations.
Participate in functions 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.
Perform equipment maintenance and calibrations as required.
Document the completion of testing in Notebooks, Controlled documents, Forms and LIMS and maintain accurate and complete quality records.
Follow, understand and comply with client SOP's and policies on cGMP's and safety. Maintain a clean, safe and organized lab area, and potentially assume responsibility to ensure that others maintain their lab areas.
Investigate deviations and write exception/OOL/OOS/OOT documents.
Support improvement projects and drive efficiency through utilization of LEAN management principles (i.e. 6S, Kaizens, etc).
Proactively and cooperatively communicate with peers and management to ensure awareness of progress and issues; recommend solutions when issues arise.
Maintain and meet the highest standards in quality, customer service and regulatory compliance.
Other projects as assigned.
Qualifications
Knowledge of Empower CDS and LIMS is preferred but not required
Knowledge of GLP, cGMP requirements and familiar with USP/ICH guidelines is preferred but not required
Excellent communication (oral and written) and interpersonal skills
Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude in a highly dynamic environment
Ability to lift up to 50 pound when required
Occasional weekend work required
Education And/or Experience
Bachelors degree in Chemistry or Science related degree with 5 years or more of experience. Or a Master's in Chemistry with 2 years or more of experience.
About Us
DivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.
DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.
Sony | (630) 847 1417
Pratichi | (630) 847 0267
Title: Quality Lab Associate II
Duration: 6 Months
Location: Round Lake, IL
Hours: 3rd shift: 10 PM to 8:30 AM
Summary
Job Description
- The Quality Lab Associate II will be located at the Drug Delivery Chemistry Laboratories, Round Lake, IL.
- The Position encompasses the biological, chemical and physical analyses on pharmaceutical products (biologics and drugs) through all stages of the manufacturing process from incoming raw materials to finished goods, and environmental monitoring programs.
- This is a first shift position but will be required to work on weekends to support training of analysts and to support projects and/or production, as required.
- A candidate must not be allergic to Penicillin and Cephalosporin or their related products and /or materials.
Conduct critical chemical and physical analyses on Raw Materials, Initial, In-process and Final products, and samples collected from environmental monitoring programs at client manufacturing facilities. Work under minimum supervision.
Review and approve laboratory data to release batches and/or raw material for use.
Use sophisticated laboratory instrumentation (HPLC, FTIR, UV, GC etc) and computer systems to collect and record data.
Perform advanced assays requiring precise analytical skills and understanding of biology and chemistry principles.
Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations.
Participate in functions 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.
Perform equipment maintenance and calibrations as required.
Document the completion of testing in Notebooks, Controlled documents, Forms and LIMS and maintain accurate and complete quality records.
Follow, understand and comply with client SOP's and policies on cGMP's and safety. Maintain a clean, safe and organized lab area, and potentially assume responsibility to ensure that others maintain their lab areas.
Investigate deviations and write exception/OOL/OOS/OOT documents.
Support improvement projects and drive efficiency through utilization of LEAN management principles (i.e. 6S, Kaizens, etc).
Proactively and cooperatively communicate with peers and management to ensure awareness of progress and issues; recommend solutions when issues arise.
Maintain and meet the highest standards in quality, customer service and regulatory compliance.
Other projects as assigned.
Qualifications
Knowledge of Empower CDS and LIMS is preferred but not required
Knowledge of GLP, cGMP requirements and familiar with USP/ICH guidelines is preferred but not required
Excellent communication (oral and written) and interpersonal skills
Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude in a highly dynamic environment
Ability to lift up to 50 pound when required
Occasional weekend work required
Education And/or Experience
Bachelors degree in Chemistry or Science related degree with 5 years or more of experience. Or a Master's in Chemistry with 2 years or more of experience.
About Us
DivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.
DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.
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