1 день назад
Supervisor, Chemistry and Stability
73 614 - 103 528$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Supervisor, Chemistry and Stability (Pharmaceutical Quality and Stability): Supervising chemistry and stability laboratory activities for testing, product release, results reporting, and regulatory stability commitments with an accent on cGMP compliance, stability protocols, and cross-functional quality coordination. Focus on investigating chamber excursions, analyzing stability data, managing shelf-life and expiry calculations, and supporting OOS, OOT, deviation, and complaint investigations.
Location: Wilson, North Carolina, United States; onsite role. Hours: 1:00pm–9:00pm.
Salary: $73,614–$103,528 annually, plus eligibility for a bonus plan with a 6% target of base salary.
Company
USA operates in the pharmaceutical manufacturing and quality environment.
What you will do
- Supervise daily activities in the Chemistry and Stability Departments, including testing, documentation review, material and product release, and results reporting.
- Coordinate personnel training, development, assignments, performance reviews, goals, and corrective actions.
- Ensure compliance with cGMP requirements, company procedures, quality systems, and regulatory expectations.
- Review stability protocols and regulatory submission sections, assess material change impacts, and manage stability commitments, expiry calculations, summaries, and archiving.
- Own stability chamber activities, investigate excursions, assess product impact, and coordinate required corrective work.
- Support investigations, corrective and preventive actions, audit responses, management reviews, department metrics, budgets, and cross-functional projects.
Requirements
- Bachelor’s degree in Chemistry or a related science.
- Five to ten years of progressive pharmaceutical laboratory experience; equivalent education and experience in pharmaceutical manufacturing, industrial, or clinical settings may be accepted.
- Knowledge of laboratory processes, procedures, regulatory requirements, and stability testing.
- Ability to analyze analytical results, solve problems, lead teams, and balance competing goals.
- Strong verbal and written communication skills, flexibility, adaptability, and ability to work in a dynamic environment.
- Effective spoken and written English is required for understanding regulated workplace policies, procedures, training materials, and communications.
Nice to have
- Knowledge of statistical analysis for product stability and shelf-life determination.
Culture & Benefits
- Medical, prescription drug, dental, and vision coverage.
- 401(k) plan with company contributions.
- Paid vacation, holidays, and personal days.
- Employee assistance, life insurance, disability coverage, and wellness programs.
- Work involves collaboration with Operations, Packaging, Quality Assurance, Stability, Validation, and Regulatory Affairs.
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