обновлено 12 дней назад
QC Chemist I
70 000 - 78 300$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
QC Chemist I (Quality Control): Supporting analytical testing, method validation, and drug stability programs within a regulated laboratory environment with an accent on chemical analysis of raw materials and finished products. Focus on ensuring compliance with FDA, GMP, and ISO standards while operating complex analytical instrumentation like HPLC and GC.
Location: Onsite in Allentown, Pennsylvania, United States. Tuesday–Saturday, 8:00 a.m.–5:00 p.m. Relocation is not available.
Salary: $70,000–$78,300 annually
Company
develops and manufactures medical products and services for healthcare, including infusion therapy, pain management, nutrition, pharmacy compounding, wound care, and dialysis.
What you will do
- Perform analytical testing of raw materials, in-process samples, finished products, and stability samples.
- Support drug stability studies through protocol execution, data review, and report preparation.
- Operate, maintain, and troubleshoot HPLC, GC, and other analytical instruments.
- Lead and support analytical method transfer, verification, and validation activities.
- Investigate OOS results, deviations, and laboratory non-conformances while supporting corrective and preventive actions.
- Collaborate with Quality, R&D, Regulatory, and Manufacturing teams and provide technical guidance to junior laboratory personnel.
Requirements
- Bachelor’s degree in Chemistry, Pharmaceutical Sciences, or a related scientific discipline.
- 4+ years of analytical laboratory experience in pharmaceutical, medical device, biotechnology, or another regulated industry.
- Strong experience with HPLC and GC instrumentation.
- Experience with Empower chromatography software and data analysis.
- Experience with analytical method validation, method transfer, and assay or impurity testing.
- Working knowledge of FDA, USP, EP, ICH, ISO, and GMP requirements, along with strong technical writing and investigation skills.
Nice to have
- Master’s degree in a relevant scientific discipline.
- Experience developing or maintaining drug stability programs.
- Experience writing stability protocols, reports, and regulatory documentation.
- Experience supporting laboratory compliance and audit readiness.
- Relevant industry or professional certifications.
Culture & Benefits
- Work within a regulated medical-device and healthcare environment focused on product quality and patient safety.
- Continuous improvement through the Sharing Expertise initiative.
- Healthcare benefits, a 401(k) plan, and tuition reimbursement.
- Collaboration across Quality, R&D, Regulatory, and Manufacturing functions.
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