4 дня назад
Manager PQA (Night Shift 12 hour) (6pm-6am)
118 235 - 159 965$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Manager PQA (Night Shift 12 hour) (6pm-6am) (GMP Quality Assurance): Leading quality assurance oversight for manufacturing and packaging operations at an Ohio biotech site with an accent on cGMP, GDP, regulatory compliance, and quality systems. Focus on managing deviations, CAPAs, change controls, validation documentation, audits, and quality risks during a 12-hour night shift.
Location: US - Ohio - New Albany. Full-time, onsite night shift from 6:00 pm to 6:00 am.
Salary: $118,235–$159,965 annually.
Company
is a biotechnology company that researches, manufactures, and delivers medicines for serious illnesses across oncology, inflammation, general medicine, and rare disease.
What you will do
- Lead, coach, and develop Quality staff across assigned areas and shifts.
- Provide QA oversight for manufacturing and packaging activities in accordance with cGMP, GDP, and global regulatory requirements.
- Review, approve, and oversee deviations, CAPAs, change controls, validation documentation, procedures, and batch records.
- Drive investigations, resolve quality deviations, and ensure production records and test results are accurate and inspection-ready.
- Partner with Manufacturing, QC, Engineering, Supply Chain, and other functions to manage quality risks and continuous improvement.
- Represent QA during audits and regulatory inspections, support inspection readiness, and maintain controlled document compliance.
Requirements
- Doctorate degree; or master’s degree and 3 years of quality experience; or bachelor’s degree and 5 years; or associate’s degree and 10 years; or high school diploma/GED and 12 years of quality experience.
- Experience directly managing people or leading teams, projects, programs, or resource allocation.
- 3+ years of Quality Assurance experience in a GMP-regulated environment, preferably biotechnology or pharmaceutical manufacturing.
- Knowledge of cGMP, GDP, regulatory expectations, deviations, CAPA, change control, validation, and quality systems.
- Ability to work a shift-based schedule, including evenings, nights, weekends, or holidays, at the New Albany, Ohio site.
- Strong communication, decision-making, problem-solving, collaboration, and cross-functional leadership skills.
Nice to have
- Bachelor’s degree in Life Sciences, Engineering, or a related field.
- Advanced degree and prior people-management experience.
Culture & Benefits
- Collaborative, innovative, and science-based work environment focused on patient safety and quality.
- Health, dental, vision, life, disability, and flexible spending benefits.
- Retirement and savings plan with company contributions.
- Annual bonus program and stock-based long-term incentives.
- Paid time-off plans and career development opportunities.
Hiring process
- Applicants may redact age-identifying information from submitted materials.
- Reasonable accommodations are available during the application and interview process.
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
6 часов назад
Associate Director, Electronic Quality Management System (eQMS)
200 700 - 233 500$
5 дней назад
Director, QA GMP Operations
188 000 - 230 000$
5 дней назад
Senior Manager, QA (Biotech)
160 000 - 186 000$
4 дня назад
Principal Quality Engineer (Pharmaceutical Manufacturing)
116 000 - 174 000$
6 дней назад
Quality Assurance, On-the-Floor (GMP)
6 дней назад
Manager Quality CQV (Pharmaceutical Validation)
125 000 - 135 000$