2 дня назад
Senior Specialist, Lead Investigator (Pharmaceutical Manufacturing)
80 000 - 117 500$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Specialist, Lead Investigator (Pharmaceutical Manufacturing): Leading investigations and root cause analysis for manufacturing issues and deviations with an accent on cGMP compliance, corrective actions, and cross-functional collaboration. Focus on defining investigation strategies, identifying root causes, developing CAPA plans, and driving complex investigations to timely closure.
Location: USA - OH - West Chester; work is performed in office, laboratory, and cGMP manufacturing environments.
Salary: $80,000–$117,500 per year.
Company
is a technology-focused biomanufacturing company building sustainable, end-to-end manufacturing solutions for medicines.
What you will do
- Lead organized investigations with defined scope, strategy, timelines, status tracking, and documented progress.
- Author investigation reports covering issue definition, scope, product impact, root cause, and corrective actions.
- Use approved investigation and Lean problem-solving tools to drive teams toward root cause.
- Coordinate cross-functional communication, investigation strategies, action plans, solution selection, and effectiveness checks.
- Prioritize and escalate issues while managing investigations through timely closure.
- Coach colleagues and build alignment on root-cause and corrective-action decisions.
Requirements
- Experience in pharmaceutical manufacturing or another regulated industry.
- Familiarity with cGMP documentation practices and applicable regulatory requirements.
- Ability to assess technical data, conduct thorough investigations, and present complex findings clearly.
- Ability to manage multiple concurrent investigations and meet objectives and timelines.
- Excellent written, verbal, presentation, and technical investigation report-writing skills.
- Ability to work independently in a fast-paced environment and own investigations through completion.
Nice to have
- Bachelor’s degree in science, engineering, or a related technical discipline; relevant experience may substitute.
- 5+ years of experience in pharmaceutical or regulated manufacturing, including quality investigations and deviation management.
- Experience across multiple sites or functions.
- Familiarity with Lean problem-solving tools and internal core business processes.
Culture & Benefits
- Full-time schedule of 8 hours, Monday through Friday.
- Annual cash bonus program and 401(k) plan with company match.
- Medical, dental, vision, life, and disability insurance.
- Paid vacation, holidays, and other leaves of absence.
- Tuition reimbursement, family-building benefits, and caregiving support.
- Visa and work authorization sponsorship are not available.
Будьте осторожны: если работодатель просит войти в их систему, используя iCloud/Google, прислать код/пароль, запустить код/ПО, не делайте этого - это мошенники. Обязательно жмите "Пожаловаться" или пишите в поддержку. Подробнее в гайде →
Похожие вакансии
2 дня назад
Senior Quality Engineer (Operations)
130 000 - 150 000$
4 дня назад
Manager- Manufacturing & Packaging Lead Engineer
99 200 - 165 400$
6 дней назад
Manufacturing Supervisor (Biopharmaceutical)
95 250 - 158 750$
1 день назад
Supervisor, Manufacturing (Cell Therapy)
90 000 - 210 000$
7 дней назад
Principal Product Technical Leader
124 400 - 207 400$
1 день назад
Senior Systems Engineer (Biotech Automation)
124 051 - 137 668$