Job Title: Quality Lab Associate II

Location: Round Lake, Illinois

Duration: 12 months contract, possible to extend

Shift Details: 2nd shift role – 2 pm – 12:30am

Pay Range : $40 to $42/hr

Job Description:

Hours: 2nd shift: 2pm to 12:30am

Summary:

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.

Essential Duties and Responsibilities:

• Conduct critical chemical and physical analyses on Raw Materials, Initial, In-process and Final products, and samples collected from environmental monitoring programs at 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 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.

#IND2

Job Type: Contract

Pay: $40.00 - $44.00 per hour

Benefits:

• Dental insurance
• Health insurance

Schedule:

• 8 hour shift
• Evening shift
• Weekend availability

Ability to commute/relocate:

• Round Lake, IL 60073: Reliably commute or planning to relocate before starting work (Required)

Application Question(s):

• Do you have experience with Investigate deviations and write exception/OOL/OOS/OOT documents?
• Do you have Knowledge of GLP, cGMP requirements and familiar with USP/ICH guidelines ?
• Ability to lift up to 50 pound when required?
• Do you have experience with laboratory instrumentation (HPLC, FTIR, UV, GC etc) and computer systems to collect and record data?
• Are you allergic to Penicillin and Cephalosporin or their related products and /or materials?
• Please confirm your email ID
• What pay rate you are looking for?

Education:

• Bachelor's (Preferred)

Experience:

• LIMS/CDS: 1 year (Preferred)

Work Location: One location

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