Laboratory Quality Assurance Associate

2 weeks 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 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 position involves conducting comprehensive biological, chemical, and physical evaluations of pharmaceutical products throughout the manufacturing lifecycle, from incoming raw materials to finished goods, including environmental monitoring.

Key Responsibilities:
  • Perform critical chemical and physical evaluations on raw materials, initial, in-process, and final products, as well as samples from environmental monitoring programs at client manufacturing sites.
  • Utilize advanced laboratory instrumentation (HPLC, FTIR, UV, GC, etc.) and computer systems for data collection and documentation.
  • Execute sophisticated assays requiring precise 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.
  • Engage in team functions that enhance production efficiency, problem-solving, cost savings, and quality improvement.
  • Conduct laboratory and manufacturing audits as necessary.
  • Update and audit 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 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 improvement initiatives and enhance efficiency through LEAN management principles (e.g., 6S, Kaizens).
  • Communicate proactively and collaboratively with peers and management to ensure awareness of progress and challenges; propose solutions when issues arise.
  • Uphold the highest standards in quality, customer service, and regulatory compliance.
  • Undertake additional projects as assigned.
Qualifications:
  • Familiarity with Empower CDS and LIMS is advantageous but not mandatory.
  • Understanding of GLP and cGMP requirements, along with knowledge of USP/ICH guidelines, is preferred 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 is 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 organization is characterized by 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.

  • Laboratory Quality Assurance Associate

    2 weeks ago

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

    Job OverviewPosition: Quality Lab Associate ILocation: Round Lake, ILDuration: 6 MonthsShift: Weekend + 2 additional nightsHours: 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 Quality Lab Associate I position involves performing biological, chemical, and physical evaluations of...

  • Laboratory Quality Assurance Associate

    2 weeks ago

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

    Job OverviewPosition Title: Quality Lab Associate ILocation: Round Lake, ILDuration: 6 MonthsShift: Weekend + 2 additional nightsHours: 4 10-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...

  • Laboratory Quality Assurance Associate

    2 weeks ago

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

    Job OverviewPosition: Quality Lab Associate ILocation: Round Lake, ILDuration: 6 MonthsShift: Weekend + 2 additional nightsHours: 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...

  • Laboratory Quality Control Associate

    2 weeks ago

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

    Job OverviewPosition Title: Quality Lab Associate ILocation: Round Lake, ILDuration: 6 MonthsShift: Weekend + 2 additional nightsHours: 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...

  • Laboratory Associate

    6 days ago

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

    Job Summary:We are seeking a highly skilled Quality Assurance Specialist to join our team at DivIHN Integration Inc. As a Quality Assurance Specialist, you will be responsible for conducting critical chemical and physical analyses on pharmaceutical products throughout the manufacturing process.Key Responsibilities:Conduct laboratory tests and analyses to...

  • Quality Assurance Specialist

    3 days ago

    Round Lake Beach, Illinois, United States BAXTER Full time

    About the RoleWe are seeking a highly skilled and detail-oriented Quality Assurance Specialist to join our team at Baxter. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and safety of our products.Key ResponsibilitiesConduct critical chemical and physical analysis on raw materials, initial, in-process, and final...

  • Quality Assurance Associate

    3 days ago

    Round Lake Beach, Illinois, United States BioSpace, Inc. Full time

    About the RoleThe primary responsibility of this position is to ensure the quality and integrity of our products by overseeing the release and approval of completed documentation for batch folders following Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP). As a Quality Assurance Associate, you will be accountable for quality oversight...

  • Quality Assurance Manager

    5 days ago

    Round Lake Beach, Illinois, United States BAXTER Full time

    About the RoleThe Quality Lab Supervisor plays a critical role in ensuring the smooth operation of the laboratory, overseeing daily activities, and implementing testing standards and policies. This position requires a strong leader who can supervise lab personnel, improve their performance, and ensure compliance with quality and regulatory requirements.Key...

  • Quality Lab Supervisor

    3 days ago

    Round Lake Beach, Illinois, United States BAXTER Full time

    About This RoleThis is a critical position within the Baxter organization, responsible for ensuring the highest standards of quality and safety in our laboratory operations.Key ResponsibilitiesSupervise and manage laboratory personnel to ensure compliance with regulatory requirements and company policies.Develop and implement quality control procedures to...

  • Quality Assurance Manager

    5 days ago

    Round Lake Beach, Illinois, United States BAXTER Full time

    About the RoleWe are seeking a highly skilled Quality Assurance Manager to join our team at Baxter. As a key member of our Manufacturing Quality Assurance team, you will be responsible for ensuring the quality and safety of our products and processes.Key ResponsibilitiesManage and coordinate routine activities and projects for an individual cell within the...

  • Quality Assurance Specialist

    5 days ago

    Round Lake, Illinois, United States Takeda Pharmaceutical Company Ltd Full time

    About the RoleWe are seeking a highly skilled Quality Assurance Specialist to join our team at Takeda Pharmaceutical Company Ltd. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our products.Key ResponsibilitiesResponsible for the receipt, release, and investigation of raw materials and bulk...

  • Quality Assurance Specialist II

    1 week ago

    Round Lake, Illinois, United States Experis Full time

    Position Overview:Our client, a leader in the Medical Device sector, is in search of a Quality Assurance Specialist to enhance their operational team. This role is crucial within the Medical Device division, ensuring compliance and quality standards are met effectively. The ideal candidate will possess 1-3 years of relevant experience in the medical device...

  • Lead, Supplier Quality Assurance Specialist

    2 days ago

    Round Lake Beach, Illinois, United States Baxter Full time

    About BaxterBaxter is a leading global healthcare company that is committed to improving patient outcomes and saving lives. Our company is built on a legacy of innovation and a passion for delivering high-quality products and services.Your Role at BaxterAs a Lead, Supplier Quality Assurance Specialist, you will play a critical role in ensuring that our...

  • Quality Assurance Specialist

    1 week ago

    Lake Forest, Illinois, United States Abbott Laboratories Full time

    About the RoleWe are seeking a highly skilled Quality Assurance Specialist to join our team at Abbott Laboratories. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and integrity of our products and processes.Key ResponsibilitiesImplement and maintain the effectiveness of the Quality System, ensuring compliance with...

  • Quality Assurance Specialist II

    2 weeks ago

    Round Lake, Illinois, United States Mindlance Full time

    POSITION SUMMARY:This document outlines the qualifications and responsibilities associated with the role of Quality Assurance Engineer, focusing on complaint investigations.KEY RESPONSIBILITIES:This role is primarily responsible for the thorough investigation, assessment, and resolution of all Quality Engineering complaint issues by utilizing various quality...

  • Quality Assurance Specialist II

    2 weeks ago

    Round Lake, Illinois, United States Mindlance Full time

    POSITION SUMMARY:This document outlines the qualifications and responsibilities associated with the role of Quality Assurance Engineer II. KEY RESPONSIBILITIES:This role is primarily accountable for the investigation, evaluation, and resolution of all Quality Engineering complaint analysis tasks utilizing various quality system inputs. Assess individual...

  • Quality Assurance Validation Specialist

    2 weeks ago

    Lake Bluff, Illinois, United States Blue Star Partners, LLC Full time

    Job Title: Validation Analyst - C Company: Blue Star Partners, LLC Contract Type: W2 onlyPosition Overview: The Validation Analyst - C will spearhead and assist in validation initiatives and deliverables for projects necessitating validation. This position encompasses the development and execution of validation test scripts, thorough documentation of test...

  • Quality Assurance Analyst II

    2 weeks ago

    Lake Bluff, Illinois, United States Experis Full time

    Company Overview:Experis IT ManpowerGroup is collaborating with a prominentMedical Device Companyto fill a critical role in their quality assurance team.Position:Quality Assurance Analyst IILocation:OnsiteContract Duration:12 monthsWorking Hours:Monday to Friday, 8 am - 4 pmCompensation:$28 per hourRole Responsibilities:As a Quality Assurance Analyst, you...

  • Quality Assurance Specialist

    2 weeks ago

    Lake Zurich, Illinois, United States Schweitzer Engineering Laboratories, Inc. Full time

    Position Overview:This role is designed to enhance manufacturing processes through dedicated quality assurance initiatives. You will engage in problem-solving and process improvement while collaborating with various teams within the organization. A solid technical foundation and the capability to work autonomously are essential for success in this...

  • Quality Assurance Specialist

    6 days ago

    Crystal Lake, Illinois, United States Technipaq- Crystal Lake Facility Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at Technipaq's Crystal Lake Facility. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality of our products and maintaining our high standards of excellence.Key ResponsibilitiesPerform routine checks, tests, and inspections of...