Quality Lab Associate I at DivIHN Integration Inc

DivIHN (pronounced “divine”) is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent.

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Title: Quality Lab Associate I
Location: Round Lake, IL
Duration: 12 Months

Description
Summary
The position may be responsible for analytical testing, validation/verification, and/or transfer of test methods supporting parenteral products. The position will be in the Round Lake, IL Stability Laboratories within Product Quality serving multiple global businesses.
This role is essential for supporting the global commercial product teams and/or product development teams. The position may interface with multiple functions. The individual in this position must: 1) Effectively demonstrate working technical knowledge and skills to support a variety of projects within the relevant discipline with minimal assistance. 2) Display basic technical understanding of related disciplines. 3) Conduct routine/non-routine experiments with minimal assistance.
A candidate must not be allergic to Penicillin and Cephalosporin or their related products and /or materials.

Essential Duties and Responsibilities.
Under direction, conduct critical chemical, physical, and biological analyses on finished product stability samples. May also support testing of raw materials, initial, in-process and final product samples from the manufacturing facility, as required. Work under minimum supervision.
Use sophisticated laboratory instrumentation and computer systems to collect and record data. May be required to conduct validations.
Complete all testing, including special project / protocol testing in a timely and appropriate manner to meet project schedules.
Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, cGxP, and QSR regulations.
Participate with management to investigate deviations and write exception documents.
May perform advanced biological and chemical assays requiring precise analytical skills and understanding of chemistry principles.
May perform review of test data, which includes overall documentation practices. May perform review functions in LIMS or other computerized systems.
May participate in cross functional teams, which impact production, increase efficiency, solve problems, generate cost savings and improve quality and provide new product support.
Maintain laboratory supplies and laboratory safety requirements to ensure audit readiness at all times.
Perform equipment maintenance and calibrations as required. Troubleshoot and resolve instrument problems with some assistance.

Qualifications.
Proficient in advanced wet chemistry, volumetric preparation techniques and instrumental methods of analysis
Must demonstrate effectiveness in attention to detail, organization, teamwork/interpersonal skills, results orientation, and task completion.
Must be able to handle multiple tasks concurrently and in a timely fashion.
Possess writing and computer skills.
Must communicate effectively with managers and peers.
Interpret available information and make recommendations to resolve technical challenges.

Education and/or Experience.
Bachelor's degree in Chemistry or biological science with analytical chemistry laboratory coursework and 0-1 years' experience.
Analytical chemistry instrumentation experience (e.g. HPLC, pH, KF, AA, GFAA, titrations, etc.) preferred.
Pharmaceutical GMP/QC laboratory experience is desired.

What are the top three to five technical skill requirements? Strong background knowledge in principles of analytical chemistry proficient in advanced wet chemistry techniques, analytical chemistry instrumentation experience (e.g. HPLC, pH, KF, AA, GFAA, titrations, etc.) preferred, recent graduate from local university with minimum 3.0 GPA desired
What are your top three to five soft skill wants? Great communication, committed, motivated, team player, results oriented
What is the expected interview process? I would like to screen the candidates and then have them go through two interviews, 2 interviewers each.

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.