3 дня назад
Associate II, Quality Assurance (Night Shift)
60 000 - 90 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Associate II, Quality Assurance (Night Shift) (GMP/biomanufacturing): Supporting quality assurance activities for pharmaceutical manufacturing processes, including batch release, documentation review, validation, investigations, and product disposition, with an accent on GMP compliance and quality systems. Focus on reviewing critical manufacturing records, resolving quality issues, supporting process improvements, and maintaining compliance during site projects and regulatory changes.
Location: West Chester, Ohio, USA; onsite night shift
Salary: $60,000–$90,000 per year
Company
is a technology-focused biomanufacturing company developing a sustainable network of high-tech, end-to-end manufacturing solutions.
What you will do
- Support QA activities within Process Execution Teams and assigned operational areas.
- Review and approve GMP documentation, including change requests, batch records, release transactions in SAP, investigations, validation documents, and SOPs.
- Execute batch record review, product disposition, and quality issue resolution.
- Support capital and non-capital projects by ensuring GMP compliance throughout planning, execution, and closeout.
- Collaborate on process improvements, risk assessments, quality metrics, and performance reports.
- Monitor evolving regulatory compliance practices and recommend implementation strategies.
Requirements
- Experience in the pharmaceutical industry, operations, or Quality Assurance.
- Excellent oral and written communication skills.
- Strong ability and motivation to learn.
- Availability for the night-shift schedule: 6:00 PM–6:30 AM, with a rotating 2-on/2-off and 3-on/3-off pattern.
- Work authorization sponsorship and visa support are not available.
Nice to have
- Bachelor’s degree; a master’s degree in science is desirable.
- Experience in a Lean, process-centric organization focused on continuous improvement.
- Multi-site or multi-functional experience.
Culture & Benefits
- Annual cash bonus program.
- 401(k) plan with company match.
- Medical, dental, and vision coverage.
- Paid vacation, holidays, and other leave.
- Tuition reimbursement and caregiving support.
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