4 дня назад
Quality Control Analyst III
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Quality Control Analyst III (Pharmaceutical QC): Performing and reviewing in-process, release, and stability testing for active pharmaceutical ingredients and filled products in a GMP laboratory with an accent on analytical methods, laboratory compliance, and scientific data integrity. Focus on leading analysts, troubleshooting and validating laboratory equipment, managing deviations and change controls, and supporting technology transfers and process improvements.
Location: Durham, North Carolina, United States; onsite pharmaceutical manufacturing facility
Company
is a global healthcare and pharmaceutical company developing and manufacturing treatments for diabetes, obesity, and other serious chronic diseases.
What you will do
- Perform and review analysis of in-process, release, and stability samples for active pharmaceutical ingredients and filled products.
- Ensure accuracy, scientific soundness, timeliness, and compliance of laboratory data with cGMP and internal procedures.
- Lead, coach, and support other analysts while maintaining testing proficiency and laboratory process competence.
- Perform investigations, deviations, change controls, data trending, and systematic problem-solving activities.
- Support laboratory equipment validation, laboratory IT systems, technical transfers, and process improvements.
- Maintain current departmental documentation and support quality control activities across relevant sites.
Requirements
- Bachelor’s degree from an accredited university, or an associate degree with seven years of relevant clinical or industrial pharmaceutical laboratory experience.
- Five years of experience in a clinical or industrial pharmaceutical laboratory.
- Advanced knowledge of GMP and laboratory techniques, with the ability to perform routine testing according to SOPs and GMP standards.
- Experience authoring scientific and technical reports, with strong verbal and written communication skills.
- Subject-matter expertise in at least one area: chemistry, microbiology, or raw materials analysis.
- Ability to work onsite in Durham, North Carolina, including handling equipment and supplies up to 33 pounds, precision hand work, occasional ladder use, and work around hazardous or odorous materials.
Nice to have
- Advanced troubleshooting skills for laboratory equipment.
- Validation and technical transfer experience.
- Project management experience.
- Experience with change control, deviations, and data trending.
Culture & Benefits
- Paid time off, including 14 paid holidays.
- Health, dental, and vision insurance effective from the first day.
- Guaranteed 8% 401(k) contribution with an additional company match option.
- Paid parental and family medical leave, life and disability insurance, and tuition assistance.
- Access to -marketed pharmaceutical products and employee referral awards.
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