Quality Specialist I - 2nd Shift
About The Position
The Quality Specialist I provides site quality support in a fast-paced environment, performing varied activities to help ensure quality and compliance with applicable regulatory requirements. The role reviews documents and data for processes in laboratories, manufacturing facilities, compliance, or regulatory teams; supports audits and inspections; consults on quality and compliance matters with guidance from the Quality team or management; maintains quality databases; and provides training as needed. The position also assists with developing or revising SOPs and other quality documents. It serves as a model for adherence to GMP and regulations and handles basic-scope problems using defined procedures, escalating issues when appropriate. This is a 100% on-site, second-shift position, Monday through Friday, from 2:30 p.m. to 11:30 p.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; alternatively, an A.A.S. in a related field with 5+ years of relevant experience or equivalent.
- Able 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.
- Able to take direction from experienced team members and contribute in a team environment.
- Good problem-solving skills and attention to detail.
- Able to repeat and follow detailed scientific procedures with supervision.
- Able to clearly present results verbally in group meetings and in written progress reports.
- Good interpersonal, written, and verbal communication skills, and willingness to ask questions about procedures and concepts.
- Aptitude and willingness to gain skills and knowledge in support of GMP regulations.
- Able to travel up to 5%.
Nice To Haves
- Relevant GMP experience preferred.
Responsibilities
- Perform quality review of moderately complex documents, data, protocols, and reports.
- Support quality floor audits and floor inspections.
- Provide real-time, on-the-floor documentation review.
- Support client and regulatory agency audits and inspections as needed.
- Maintain quality databases and potentially perform analysis and trending.
- Assist with quality improvement initiatives.
- Assist with developing or revising quality SOPs, other quality documents, and reports.
- Provide consultation and training on quality and compliance topics in areas of expertise.
- Understand Quality Management Systems, including Investigations, Corrective Actions, and Change Control.
- Perform moderately complex duties accurately and on schedule.
- Maintain accurate files and records.
- Complete required company training on time and comply with cGMP and other relevant training requirements.
- Conduct routine assignments with support and work to master basic Quality business unit tasks.
- Perform other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
