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Laboratory Quality Assurance Associate

2 months ago

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

Position: Quality Lab Associate I

Location: Round Lake, IL

Duration: 6 Months

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

Role Summary:

The role involves conducting biological, chemical, and physical evaluations of pharmaceutical products throughout the manufacturing process, from incoming raw materials to finished products, including environmental monitoring.

Key Responsibilities:
  • Perform essential chemical and physical analyses on raw materials, in-process, and final products, as well as samples from environmental monitoring.
  • Utilize advanced laboratory instruments (HPLC, FTIR, UV, GC, etc.) and computer systems for data collection and documentation.
  • Execute complex assays requiring strong analytical skills and a solid understanding of biological and chemical principles.
  • Ensure data integrity and compliance with company SOPs, FDA, GLP, QSR, and cGMP regulations.
  • Collaborate with teams to enhance production efficiency, resolve issues, and implement cost-saving measures.
  • 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 outcomes in notebooks, controlled documents, forms, and LIMS, maintaining accurate quality records.
  • Adhere to client SOPs and safety policies related to cGMPs.
  • Maintain a clean and organized laboratory environment and encourage others to do the same.
  • Investigate deviations and prepare exception/OOL/OOS/OOT documentation.
  • Support process improvement initiatives and enhance efficiency using LEAN management principles.
  • Communicate effectively with peers and management to keep all parties informed of progress and challenges, offering solutions as necessary.
  • Uphold the highest standards in quality, customer service, and regulatory compliance.
  • Engage in additional projects as assigned.
Qualifications:
  • Familiarity with Empower CDS and LIMS is advantageous but not mandatory.
  • Understanding of GLP and cGMP standards, along with knowledge of USP/ICH guidelines, is preferred.
  • Strong communication skills, both verbal and written, along with excellent interpersonal abilities.
  • Capacity to work independently and collaboratively, demonstrating self-motivation, adaptability, and a positive outlook in a dynamic environment.
  • Able to lift up to 50 pounds when necessary.
  • Availability for occasional weekend work.
  • 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, specializes in Professional Consulting, Custom Projects, and Resource Augmentation services for clients across the Mid-West and beyond. Our core values emphasize 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, age, national origin, disability, marital status, sexual orientation, or military status.