Quality Specialist I - 12-Hr Night Shift 2-2-3
About The Position
The Quality Specialist I provides on-site quality support in a fast-paced environment, performing a variety of activities to ensure quality and compliance with applicable regulatory requirements. The role reviews documents and data relevant to processes in laboratory, manufacturing, compliance, or regulatory settings; supports audits and inspections; consults on quality and compliance issues with guidance from the Quality team or management; maintains quality databases; and provides training as needed. The specialist also assists with developing or revising SOPs and other quality documents and serves as a model for adherence to GMP and regulations. The position handles basic-scope problems using defined procedures and practices, exercising judgment and escalating issues when needed. This is a 100% on-site position on a 12-hour rotating night shift, 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 with 0–2+ years of relevant experience or equivalent, or an A.A.S. in a related field with 5+ years of relevant experience or equivalent.
- Ability to comply with SOPs and regulatory requirements.
- Basic knowledge of quality and regulatory concepts, principles, and procedures.
- Basic computer skills, including familiarity with ERP, EDMS, Microsoft Word, PowerPoint, and Excel.
- Ability to follow directions from experienced team members and contribute in a team environment.
- Good problem-solving skills and attention to detail.
- Ability to follow detailed scientific procedures under supervision.
- Ability to present results clearly in group meetings and written progress reports.
- Good interpersonal, written, and verbal communication skills; willingness to ask questions about procedures and concepts.
- Ability to work on basic problems using practical problem-solving methods with supervision and follow detailed instructions.
- Ability to gain skills and knowledge in support of GMP regulations.
- Ability to meet the physical demands of the position, including standing, walking, sitting, reaching, handling objects, and lifting or moving loads up to 50 pounds as described in the posting.
- Ability to wear appropriate personal protective equipment when performing job duties.
Nice To Haves
- Relevant GMP experience is preferred.
Responsibilities
- Performs quality review of moderately complex documents, data, protocols, and reports.
- Supports quality floor audits and inspections.
- Provides real-time, on-the-floor documentation review.
- Supports client and regulatory agency audits and inspections as needed.
- Maintains quality databases and may perform analysis and trending.
- Assists with quality improvement initiatives.
- Assists with developing or revising quality SOPs, other quality documents, and reports.
- Provides consultation on quality and compliance topics within areas of expertise.
- Provides training on quality and compliance topics within areas of expertise.
- Understands Quality Management Systems, including investigations, corrective actions, and change control.
- Performs a variety of moderately complex duties accurately and on schedule.
- Maintains accurate files and records.
- Completes required company training on time and complies with cGMP and other relevant requirements.
- Conducts routine assignments with support and works to master basic Quality business unit tasks.
- Performs other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
