2 дня назад
Associate II, Quality Lab (Pharmaceutical Quality)
68 000 - 93 500$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Associate II, Quality Lab (Pharmaceutical Quality): Conducting chemical, physical, and environmental analyses for pharmaceutical products throughout the manufacturing process with an accent on advanced assays, chromatography instrumentation, and regulatory compliance. Focus on reviewing test data, investigating deviations and OOS/OOT results, maintaining data integrity, and supporting laboratory efficiency improvements.
Location: Round Lake, Illinois, United States; first-shift manufacturing facility role with occasional weekend work required
Salary: $68,000–$93,500 annually, plus potential discretionary bonus
Company
Healthcare company focused on developing and manufacturing products that save and sustain lives.
What you will do
- Conduct chemical and physical analyses of raw materials, in-process samples, finished pharmaceutical products, and environmental monitoring samples.
- Perform advanced chemical assays using laboratory instrumentation such as HPLC and GC, and record results in LIMS and controlled documentation.
- Review test data, complete product release functions, maintain quality records, and ensure data integrity.
- Investigate deviations and prepare exception, OOL, OOS, and OOT documentation.
- Mentor and train Quality Laboratory Associate I staff, provide work direction, and collaborate on production and quality improvement projects.
- Perform audits, equipment maintenance and calibration, SOP updates, and laboratory safety activities.
Requirements
- Bachelor’s degree in Chemistry or a physical science and at least 2 years of experience.
- Advanced laboratory skills, strong analytical and technical problem-solving abilities, and basic knowledge of statistical methods.
- Ability to work independently, manage multiple tasks, communicate effectively, and train others.
- Knowledge of cGMP, GLP, FDA, QSR, USP, and ICH requirements is preferred; Empower Chromatography Data System and LIMS knowledge is preferred but not required.
- Ability to lift up to 50 pounds, occasional weekend work, and compliance with safety requirements.
- Must be authorized to work for any employer in the United States; visa sponsorship is not available. Must not be color blind or allergic to Penicillin, Cephalosporin, or related products or materials.
Culture & Benefits
- Medical, dental, and vision coverage starting on day one.
- Paid time off, paid holidays, paid parental leave, and family and medical leave.
- 401(k) contributions with company matching and an employee stock purchase program.
- Tuition reimbursement and educational assistance.
- Collaborative quality-focused environment with opportunities to improve processes through Lean principles such as 6S and Kaizen.
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