4 дня назад
Sr. Associate Plant QA 12 Hour Night Shift (6pm- 6am)
82 081 - 111 052$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Sr. Associate Plant QA 12 Hour Night Shift (6pm- 6am) (GMP/pharmaceutical manufacturing): Providing quality assurance guidance for production, monitoring GMP operations, and reviewing batch records for commercial device assembly, packaging, and labeling with an accent on compliance, documentation accuracy, and quality systems. Focus on approving SOPs and GMP records, managing deviations, CAPA, and change controls, and supporting regulatory inspections and operational excellence initiatives.
Location: New Albany, Ohio, United States; 12-hour night shift from 6:00 PM to 6:00 AM
Salary: $82,081.95–$111,052.05 per year
Company
is a biotechnology company researching, manufacturing, and delivering medicines for serious illnesses across oncology, inflammation, general medicine, and rare disease.
What you will do
- Provide daily quality guidance to production staff on SOPs, work instructions, GMP compliance, and quality systems.
- Maintain a regular presence in device assembly and packaging areas and act as the quality contact during packaging and labeling operations.
- Review and approve batch production records, GMP documentation, controlled documents, and finished product checks.
- Compile batch records for commercial lots in preparation for batch disposition.
- Review and approve deviation, CAPA, and change control records.
- Support inspections, Lean Transformation, Operational Excellence, and site safety initiatives while collaborating with production, warehouse, facilities, maintenance, and engineering stakeholders.
Requirements
- High school diploma or GED plus 4 years of quality or GMP manufacturing experience; or an associate degree plus 2 years; or a bachelor's degree plus 6 months; or a master's degree.
- Experience with GMP/GCP operations or a similarly regulated industry.
- Strong verbal and written communication, interpersonal, organizational, and problem-solving skills.
- High attention to detail and accuracy in GMP documentation, with the ability to work autonomously and identify potential issues.
- Experience with enterprise resource management and quality systems such as SAP, TrackWise, or CDOCS.
Nice to have
- Scientific degree in life sciences, physical sciences, applied engineering, or manufacturing technologies.
- Experience with raw material receipt, inspection, and sampling.
- Affinity with digital innovation, data sciences, and quality engineering.
Culture & Benefits
- Health, dental, vision, life, disability, and flexible spending benefits.
- Retirement and savings plan with company contributions.
- Discretionary annual bonus program and stock-based long-term incentives.
- Paid time-off plans and career development opportunities.
- Work models may include remote or hybrid arrangements where applicable, although this plant-based role requires regular onsite presence.
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