1 день назад
Sr. QA Specialist - Pharmaceutical Manufacturing
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Sr. QA Specialist - Pharmaceutical Manufacturing (GMP/Quality Assurance): Reviewing and approving manufacturing documentation and batch records to certify compliance for biologics produced at a commercial-scale GMP facility, with an accent on deviations, validation documentation, CAPA, and QA training. Focus on mentoring QA colleagues, resolving quality issues with Manufacturing and Quality Control, and driving cross-functional quality improvement projects.
Location: Onsite at the West Lebanon, New Hampshire bio-production facility, Monday–Friday.
Company
is a global healthcare company developing and manufacturing treatments for diabetes, obesity, rare blood and endocrine disorders, and other serious chronic diseases.
What you will do
- Review and approve manufacturing, support, batch, testing, and ancillary records for compliance with internal standards and GMP.
- Exercise QA signature authority for individual batch records and related documentation.
- Review and assess deviations, including tracking, follow-up, reporting, and trend analysis.
- Review and approve validation documentation and corrective and preventive action reports.
- Train, mentor, and develop QA colleagues, including delivering compliance and QA-related training.
- Partner with Manufacturing and Quality Control to resolve record review, audit, and deviation issues and support cross-functional quality projects.
Requirements
- Bachelor’s degree in a scientific or life science discipline.
- At least 10 years of experience with a bachelor’s degree, or 8 years with a master’s degree.
- Six years of direct QA experience preferred.
- Extensive knowledge and proven experience in GMP API manufacturing within the pharmaceutical industry.
- Excellent written and verbal English communication skills are required.
- Strong planning, organization, judgment, stakeholder management, collaboration, and QA mentoring skills.
Nice to have
- Master’s degree in a scientific or life science discipline.
Culture & Benefits
- Work in a supportive manufacturing community focused on ethics, quality, and patients.
- Access to career development opportunities, resources, and mentorship.
- Work at a 24/7 commercial-scale GMP manufacturing facility producing biologics and other medicines.
- Local and international travel of approximately 0–5%.
- Inclusive recruitment process and equal employment opportunity.
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
4 дня назад
Sr Associate QA I - PQA
7 дней назад
Senior Specialist, On-the-Floor, Quality Assurance
1 день назад
Manager Quality Assurance (Biotechnology)
92 200 - 176 000$
6 дней назад
Quality Assurance Specialist II - Viral Vector
5 дней назад
Quality Assurance Specialist (Batch Record & Disposition) (Biotech)
62 355 - 110 000$
4 дня назад