What are the responsibilities and job description for the Quality Assurance Document Specialist position at Gemini Pharmaceuticals Inc?
Job Description
Quality Specialist – Sanitation & Environmental Monitoring / Documentation Specialist
Position Summary
The Quality Specialist – Sanitation & Environmental Monitoring is responsible for ensuring the effectiveness of facility cleaning, sanitization, environmental monitoring, and hygiene programs throughout the manufacturing operation. This position supports Quality Assurance by verifying sanitation practices through ATP testing, visual inspections, environmental monitoring, documentation review and trend analysis while ensuring compliance with Current Good Manufacturing Practices (cGMP), 21 CFR Part 111, HACCP, FSSC 22000, customer requirements, and company procedures.
The Quality Specialist works closely with Production, Sanitation, Maintenance, and Warehouse teams to prevent contamination, reduce food safety risks, and maintain an audit-ready facility.
Essential Responsibilities
ATP Verification & Monitoring Program
- Perform routine ATP swabbing throughout manufacturing, packaging, warehouse, and support areas.
- Develop and maintain ATP sampling schedules based on risk assessments.
- Verify effectiveness of cleaning and sanitization activities.
- Investigate ATP failures and perform re-swabbing as required.
- Trend ATP data and identify recurring sanitation issues.
- Recommend corrective and preventive actions based on ATP trends.
- Neogen Analytics
Environmental Monitoring
- Conduct environmental monitoring sampling according to established programs.
- Collect microbiological and environmental samples.
- Review laboratory results and investigate out-of-specification findings.
- Maintain environmental monitoring records and trend reports.
- Recommend improvements based on monitoring data.
- Maintain HACCP PLAN
Documentation & Data Management
- Develop & maintain work instructions related to ATP program.
- Maintain ATP logs and environmental monitoring records (Neogen Analytics).
- Review sanitation documentation for completeness and accuracy.
- Generate weekly and monthly sanitation performance reports.
- Trend sanitation effectiveness using KPIs.
- Support CAPAs, deviations, and investigations.
- Partners with various Quality Management System (QMS) teams to support data needs; defines and document requirements for new metrics and reports.
- Translates both technical and non-technical data requirements into metrics, reports and visualization dashboards.
- Ability to execute deep dives into available data sets to provide insight on product quality performance and KPIs.
- Participate in improvement initiatives and develop data extracts needed to identify weakness and opportunities that will enhance production process improvements, organizational growth and cost effective measures.
- Develop user documentation and a variety of visual representation of data analysis and ensures consistency and accuracy of data and analysis provided.
- Support business system integrations of data needs and report outputs
- Perform ongoing monitoring and refinement of reports and analytical solutions to ensure a good user experience in support reports and dashboards.
- Perform functional, regression, useability tests etc., as applicable for both new and existing datasets, reports and dashboards. Document and summarize test results and findings as required.
- Use technical expertise and understanding of business process needs to turn data into useful information
- Incorporates industry benchmarks to illustrate baseline metrics and current state when publishing charts, graphs, pivot tables and other diagrams
- Other projects/ duties as assigned by Vice President of Quality
- Should be able to wear a filtering facepiece (dust mask, surgical mask, respirator) throughout the day when required.
Qualifications
Education
- Bachelor's degree in Food Science, Microbiology, Biology, or related field preferred.
- Equivalent manufacturing experience will be considered.
Experience
- 3–5 years of Quality Assurance or Food Safety experience in a dietary supplement, pharmaceutical, food, or regulated manufacturing environment.
- Experience performing ATP verification and environmental monitoring.
- Experience with sanitation validation and cleaning verification.
- Knowledge of cGMPs and FDA regulations.
Knowledge & Skills
- Knowledge of 21 CFR Part 111.
- Knowledge of HACCP principles.
- Understanding of environmental monitoring programs.
- Knowledge of ATP testing methodologies.
- Strong understanding of sanitation chemicals and cleaning validation.
- Familiarity with allergen control and cross-contamination prevention.
- Strong investigation and root cause analysis skills.
- Excellent documentation and technical writing skills.
- Proficiency with Microsoft Office and quality management systems.
Physical Requirements
- Ability to stand and walk for extended periods.
- Ability to lift up to 40 pounds.
- Ability to work in manufacturing, warehouse, and packaging environments.
- Ability to wear required PPE.
- Ability to work flexible hours when production schedules require.
9am-5pm
Salary : $25 - $30