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Laboratory Quality Control Associate

2 months ago

Round Lake, Illinois, United States DivIHN Integration Inc Full time
Job Overview

Position Title: Quality Lab Associate I

Location: Round Lake, IL

Duration: 6 Months

Shift: Weekend + 2 additional nights
Hours: 4 ten-hour shifts (Friday through Sunday 10 pm to 8:30 am and two nights of choice for the 40 hours)

Role Summary:

The Quality Lab Associate I role involves conducting biological, chemical, and physical evaluations of pharmaceutical products throughout the manufacturing process, from incoming raw materials to finished products, as well as overseeing environmental monitoring initiatives.

Key Responsibilities:
  • Perform essential chemical and physical evaluations on raw materials, initial, in-process, and final products, as well as samples from environmental monitoring at client manufacturing sites, with minimal supervision.
  • Utilize advanced laboratory instruments (HPLC, FTIR, UV, GC, etc.) and computer systems for data collection and documentation.
  • Execute complex assays requiring precise analytical capabilities and a solid understanding of biological and chemical principles.
  • Ensure data integrity and compliance with company SOPs, FDA, GLP, QSR, and cGMP regulations.
  • Engage in team functions that enhance production efficiency, problem-solving, cost savings, and quality improvement.
  • Conduct laboratory and manufacturing audits as necessary.
  • Review and update plant SOPs as required.
  • Perform maintenance and calibration of laboratory equipment as needed.
  • Document testing completion in Notebooks, Controlled documents, Forms, and LIMS, maintaining accurate quality records.
  • Adhere to client SOPs and policies regarding cGMPs and safety.
  • Maintain a clean, safe, and organized laboratory environment, potentially overseeing the cleanliness of others' workspaces.
  • Investigate deviations and prepare exception/OOL/OOS/OOT documentation.
  • Support process improvement initiatives and enhance efficiency using LEAN management principles (e.g., 6S, Kaizens).
  • Communicate proactively and collaboratively with peers and management to ensure awareness of progress and challenges; propose solutions as needed.
  • Uphold the highest standards in quality, customer service, and regulatory compliance.
  • Other responsibilities as assigned.
Qualifications:
  • Familiarity with Empower CDS and LIMS is preferred but not mandatory.
  • Understanding of GLP and cGMP requirements and knowledge of USP/ICH guidelines are advantageous but not essential.
  • Strong communication (oral and written) and interpersonal skills.
  • Ability to work independently and collaboratively within a team, demonstrating self-motivation, adaptability, and a positive attitude in a dynamic environment.
  • Capability to lift up to 50 pounds when necessary.
  • Occasional weekend work may be required.
  • Must not have color blindness.
Education and Experience:

Bachelor's degree in Chemistry or a related scientific field with a minimum of 6 months of relevant experience.

About DivIHN:

DivIHN, the 'IT Asset Performance Services' organization, offers Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients across the Mid-West and beyond. Our strategic focus is on Standardization, Specialization, and Collaboration.

DivIHN is an equal opportunity employer and does not discriminate against any employee or qualified applicant based on race, color, religion, gender, gender expression, age, national origin, disability, marital status, sexual orientation, or military status.