Statistical Process Control Analyst
Thermo Fisher Scientific
Summary
As a Statistical Process Control Analyst in Biostatistics at Thermo Fisher Scientific, you will work on collecting, analyzing, and interpreting manufacturing and quality data to monitor process performance, identifying trends, supporting technology transfers, and supporting continuous improvement initiatives. You'll develop and maintain statistical process control tools, evaluate process capability, and recommend inspection limits and control strategies based on sound statistical principles.
Job description
A Day in the Life
You will be responsible for collecting, analyzing, and trending manufacturing and quality data using statistical methods and provide technical expertise for statistic analysis of process capability and as part of trend investigations. You will develop, maintain, and monitor statistical process control charts for critical process and quality attributes and perform process capability analyses across multiple products. You will assist with statistical evaluation of manufacturing processes as part of continuous process validation. You will recommend establishment or revisions of inspection limits, alert limits, and action limits based on statistical analysis of historical data.
Keys to Success
Education
- Advanced degree with no prior experience, or Bachelor's degree plus 2 or more years of relevant experience in statistical analysis, manufacturing, quality, or process engineering
- Combination of education and experience will be considered
- Preferred Fields of Study: Statistics, Mathematics, Biostatistics, Data Science, or a related discipline
Experience
- Demonstrated experience in collection, analysis, and trending of manufacturing and quality data using statistical methods
- Strong knowledge of GMP and regulatory requirements
- Knowledge of statistical process control methodologies
- Proficient in statistical analysis of data sets coming from the manufacturing process
- Ability to interpret complex data and communicate findings effectively to multi-departmental audiences
- Proficiency with Minitab, MS Office applications specifically Word, Excel, and PowerPoint
Knowledge, Skills, Abilities
- Excellent analytical and problem-solving skills
- Strong written and verbal communication skills
- Ability to work effectively in a dynamic manufacturing environment
- Strong attention to detail and organizational skills
Requirements
- Advanced degree with no prior experience, or Bachelor's degree plus 2 or more years of relevant experience in statistical analysis, manufacturing, quality, or process engineering
- Combination of education and experience will be considered
- Preferred Fields of Study: Statistics, Mathematics, Biostatistics, Data Science, or a related discipline
- Demonstrated experience in collection, analysis, and trending of manufacturing and quality data using statistical methods
- Strong knowledge of GMP and regulatory requirements
- Knowledge of statistical process control methodologies
- Proficient in statistical analysis of data sets coming from the manufacturing process
- Ability to interpret complex data and communicate findings effectively to multi-departmental audiences
- Proficiency with Minitab, MS Office applications specifically Word, Excel, and PowerPoint
- Excellent analytical and problem-solving skills
- Strong written and verbal communication skills
- Ability to work effectively in a dynamic manufacturing environment
- Strong attention to detail and organizational skills
Benefits
- Medical, Dental & Vision
- Paid Time Off & Holidays
- 401(k) Matching
- Tuition Reimbursement
- Employee Referral Bonus
- Employee Discount Program
- Recognition Program
- Charitable Gift Matching
- Paid Parental Leave
- Accident Insurance
- Life Insurance
- Short-term Disability
- Long-term Disability
- Employee Stock Purchase Plan
Company overview
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. The company's mission is to enable customers to make the world healthier, cleaner, and safer. With over 100,000 employees globally, Thermo Fisher provides an unrivaled combination of innovative technologies, purchasing convenience, and pharmaceutical services through its industry-leading brands including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD. The company serves customers across healthcare, life sciences, applied markets, and pharmaceutical sectors, offering solutions that accelerate research, solve complex analytical challenges, improve patient diagnostics, and increase laboratory productivity. Headquartered in Waltham, Massachusetts, Thermo Fisher operates globally, delivering critical scientific products, services, and workflow solutions that support researchers, organizations, and companies in addressing some of the world's most pressing issues.