Quality Lab Associate I
About The Position
The Quality Lab Associate I position is based in Baxter’s Round Lake, Illinois Stability Laboratories within Global Quality. The role may involve analytical testing, validation or verification, and/or transfer of test methods supporting parenteral products. It supports global commercial product teams and/or product development teams and may interface with multiple functions. The associate is expected to apply working technical knowledge to projects in the relevant discipline with minimal assistance, demonstrate basic understanding of related disciplines, and conduct routine and non-routine experiments with minimal assistance. Under direction and with minimum supervision, the associate conducts chemical, physical, and biological analyses of finished-product stability samples and may also test raw materials and initial, in-process, and final product samples. The role uses laboratory instrumentation and computer systems to collect and record data, maintains data integrity and regulatory compliance, and completes testing in accordance with project schedules. Other duties include supporting investigations and documentation, reviewing test data and documentation, maintaining laboratory supplies and safety, and maintaining, calibrating, and troubleshooting equipment. The candidate must not be allergic to penicillin, cephalosporin, or related products or materials.
Requirements
- Bachelor of Science degree in Chemistry or biological science, including analytical chemistry laboratory coursework.
- 0–1 years of experience.
- Proficiency in advanced wet chemistry, volumetric preparation techniques, and instrumental methods of analysis.
- Attention to detail, organization, teamwork and interpersonal skills, results orientation, and task completion.
- Ability to handle multiple tasks concurrently and in a timely fashion.
- Writing and computer skills.
- Ability to communicate effectively with managers and peers.
- Ability to interpret available information and make recommendations to resolve technical challenges.
- Must not be allergic to penicillin, cephalosporin, or related products and/or materials.
Nice To Haves
- Experience with analytical chemistry instrumentation such as HPLC, pH, KF, AA, GFAA, and titrations.
- Pharmaceutical GMP/QC laboratory experience.
Responsibilities
- Conduct chemical, physical, and biological analyses of finished-product stability samples; support testing of raw materials and initial, in-process, and final product samples as required.
- Use laboratory instrumentation and computer systems to collect and record data; conduct validations when required.
- Complete testing, including special-project and protocol testing, in a timely manner to meet project schedules.
- Maintain data integrity and comply with company SOPs and specifications, FDA requirements, cGxP, and QSR regulations.
- Participate with management in investigating deviations and writing exception documents.
- Perform advanced biological and chemical assays when required.
- Review test data and documentation, including through LIMS or other computerized systems, when required.
- Participate in cross-functional teams supporting production, efficiency, problem-solving, cost savings, quality improvement, and new products.
- Maintain laboratory supplies and safety requirements to ensure audit readiness.
- Perform equipment maintenance and calibrations, and troubleshoot and resolve instrument problems with some assistance.
- Perform other duties as assigned.
Benefits
- Medical and dental coverage starting on day one
- Basic life, accident, short-term disability, long-term disability, and business travel accident insurance
- Employee Stock Purchase Plan with the ability to purchase company stock at a discount
- 401(k) Retirement Savings Plan with employee contributions and company matching
- Flexible Spending Accounts
- Educational assistance programs
- Paid holidays
- Paid time off ranging from 20 to 35 days based on length of service
- Family and medical leaves of absence
- Paid parental leave
- Commuting benefits
- Employee Discount Program
- Employee Assistance Program
- Childcare benefits
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
