Sr. Associate Plant QA 12 Night Shift (6pm- 6:30am)

Location: New Albany, Ohio, United States; onsite night shift from 6:00pm to 6:30am

Salary: $82,081.95–$111,052.05 per year

Company

A biotechnology company developing and manufacturing medicines for serious illnesses across oncology, inflammation, general medicine, and rare disease.

What you will do

• Provide daily QA 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, SOPs, work instructions, and forms.
• Compile and review batch records for commercial lots and perform finished-product checks in preparation for batch disposition.
• Review and approve deviation, CAPA, and change-control records while supporting inspections.
• Coach operations and support personnel, contribute to quality culture, and support Lean Transformation, Operational Excellence, and EHSS initiatives.

Requirements

• High school diploma or GED plus 4 years of Quality and/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 is preferred.
• Strong verbal and written communication, interpersonal, organizational, and documentation skills.
• Ability to work autonomously, provide updates to senior management, identify potential issues, and complete assignments accurately.
• Experience with enterprise resource management and quality systems such as SAP, TrackWise, or CDOCS is preferred.
• Regular onsite presence in the production, assembly, and packaging areas is required.

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.
• Annual bonus program and stock-based long-term incentives.
• Paid time-off plans and career development opportunities.
• Inclusive, collaborative, science-based work environment.
• Sponsorship for this role is not guaranteed.