Operations Compliance Specialist
About The Position
The Operations Compliance Specialist is responsible for ensuring compliance in production areas is adhered to at all times. This includes but is not limited to, a review of SOPs, identifying GAPS in SOPs and Processes with appropriate CAPA, change control, and risk mitigation provisions to ensure 100% compliance. To succeed in this position, a person must have a thorough understanding of the FDA GMP requirements, Pharmaceutical technical processes, a mindset of high standards for Quality, and the ability to express complex technical problems in simple, straightforward language, both verbally and in writing.
Requirements
- Associate or bachelor’s degree in a scientific field or 3-5 years of extensive experience in the pharmaceutical industry, preferably in Product Manufacturing with demonstrated experience working in Quality functional areas.
- Excellent problem-solving skills.
- Working knowledge of root cause analysis tools
- Excellent technical writing skills
- Expert knowledge of manufacturing operations
- Working knowledge of Microsoft Word, Excel, and PowerPoint is necessary
Responsibilities
- Provides leadership to production staff for compliance-related matters.
- Conducts thorough GAPA analysis for production quality systems and processes, identifying opportunities for risks, including prevention, monitoring, and resolution, and placing appropriate measures to mitigate risks.
- Coaches and Mentors, compliance investigators on conducting root cause analysis and placing appropriate CAPA in place to prevent recurrences.
- Acts as a Subject Matter Expert on behalf of production for any continuous improvement, facility expansion, and process improvement projects.
- Acts as a Subject Matter Expert during regulatory audits.
- Monitors trends and conducts trend analysis for deviations, change controls and CAPAs to understand trends and provides findings to production management with alternate solutions to prevent recurrences.
- Providing training and awareness to educate employees in in-scope business areas on emerging risks, issues, and policy requirements.
- Routine interaction with the site management, including compilation of spreadsheets to communicate investigational status and CAPA discussions.
- Work on the production floor for data gathering and observing processes for enhanced compliance.
- Perform other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Associate degree
