Quality Specialist II - 12-Hr Night Shift 2-2-3
About The Position
The Quality Specialist II provides on-site quality support in a fast-paced environment, performing varied activities to ensure quality and compliance with applicable regulatory requirements. The role reviews documents and data for processes in laboratory, manufacturing, compliance, or regulatory settings; supports audits and inspections; consults on quality and compliance matters; maintains quality databases; performs trend analysis where needed; and provides quality and compliance training. The position also develops SOPs and other quality documents as needed and serves as a model for adherence to GMP and regulations. The role handles problems of basic scope, applying judgment within defined procedures and practices and escalating issues when needed. This is a 100% on-site, 12-hour rotating night-shift position on a 2-2-3 schedule, from 7:00 p.m. to 7:00 a.m. Up to 5% travel is required.
Requirements
- B.S., B.A., or M.S. in a related field and 2–7+ years of relevant experience or equivalent; alternatively, an A.A.S. in a related field and 10+ years of relevant experience or equivalent.
- Ability to comply with SOPs and regulatory requirements.
- Basic knowledge of quality and regulatory concepts, principles, and procedures.
- Ability to work on basic problems and use practical problem-solving methods with minimal supervision; assignments require detailed and specific instructions.
- Basic computer skills, including familiarity with ERP, EDMS, Microsoft Word, PowerPoint, and Excel.
- Ability to take direction from experienced team members and contribute to a team environment.
- Good problem-solving skills and attention to detail.
- Ability to repeat and follow detailed scientific procedures with supervision.
- Ability to present results clearly in group meetings and written progress reports.
- Good interpersonal skills and willingness to ask questions about procedures and concepts.
- Good written and verbal communication skills.
- Ability to meet the physical demands described, including standing, walking, sitting, and lifting or moving items up to the stated weights; use required personal protective equipment.
- Willingness and aptitude to develop skills and knowledge supporting GMP regulations.
- Willingness to travel up to 5%.
Nice To Haves
- Relevant GMP experience preferred.
Responsibilities
- Perform quality reviews of complex documents, data, protocols, and reports.
- Support quality floor audits and inspections.
- Support client and regulatory agency audits and inspections as needed, while seeking to understand customer needs.
- Maintain quality databases and perform analysis and trending as applicable.
- Assist with quality improvement initiatives.
- Identify and report issues in a timely manner.
- Develop quality SOPs, other quality documents, and reports as needed.
- Provide consultation on complex quality and compliance topics within areas of expertise.
- Develop and provide training on quality and compliance topics within areas of expertise.
- Apply understanding of Quality Management Systems, including investigations, corrective actions, and change control.
- Perform varied complex duties accurately, competently, and on schedule.
- Maintain accurate files and records.
- Complete required company training on time and comply with cGMP and other relevant requirements.
- Respond to inquiries in a timely manner.
- Conduct routine assignments independently with support.
- Master basic Quality business-unit tasks applicable to the role and exercise independent signature authority for those competencies.
- Perform other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
