Laboratory Data Analyst
Company Name:
UCB/Kremers Urban
Kremers Urban (KU) Pharmaceuticals is a multinational pharmaceutical company. We strive to serve unmet medical needs by developing and marketing innovative products for specialty markets. We are committed to providing excellent services to our customers and creating significant value for our investors.
We foster an employee culture that remains focused on the individuality of each employee and the unique contribution value that each person can bring to KU.
Job
Summary:
This position is primarily responsible for statistical design and statistical analysis of Drug Product and Stability results to support in-process, drug product release and stability testing and assist in laboratory investigations.
Essential Functions:
The role will provide statistical support to the Laboratory Operations Drug Product and Stability group through experimental design, statistical analysis, and presentation of results.
Assist in the effective and timely investigation of out-of-specification and out-of-trend data. Assist in determining root causes and suggest appropriate CAPAs.
Review and provide input in investigation reports and annual product review reports.
Monitor release and stability results for developing trends.
Provide statistical analysis of stability data as part of the stability reports.
Provide statistical guidance in analytical method development; suggest improvements to existing methods.
Evaluate equivalency of data sets such as for method transfers, alternate methods, raw material certification, and stability evaluations of alternate configurations.
Training or
Experience:
At least 5 years of pharmaceutical testing experience in a cGMP-regulated laboratory environment.
Pharmaceutical industry statistical experience required
Knowledge of cGMP, USP/NF, ICH, EU and FDA guidelines and regulations.
Excellent oral communication skills and technical writing skills.
Well organized, detail-oriented, and dependable.
Able to assist with troubleshooting analytical methods and laboratory instrumentation (e.g. HPLC, GC, dissolution, wet chemistry).
Expertise in MiniTab, Microsoft Word and Excel. Experience with Stability System Software and SAS preferred.
Demonstrated ability to work as part of a cross-functional team.
Education:
Minimum of a BS Degree in Mathematics, Chemistry or related field.
Kremers Urban offers competitive packages (medical, vision, dental, vacation, paid holidays and 401(k), growth potential, and a challenging and exciting work environment.
Should you have interest in joining our team, feel free to apply to http://www.kremersurban.com/careers/Careers.aspx.
UCB and its subsidiaries encourage diversity in the workplace, we are an Equal Opportunity Employer. Minority/Female/Disability/Veteran.Estimated Salary: $20 to $28 per hour based on qualifications.
UCB/Kremers Urban
Kremers Urban (KU) Pharmaceuticals is a multinational pharmaceutical company. We strive to serve unmet medical needs by developing and marketing innovative products for specialty markets. We are committed to providing excellent services to our customers and creating significant value for our investors.
We foster an employee culture that remains focused on the individuality of each employee and the unique contribution value that each person can bring to KU.
Job
Summary:
This position is primarily responsible for statistical design and statistical analysis of Drug Product and Stability results to support in-process, drug product release and stability testing and assist in laboratory investigations.
Essential Functions:
The role will provide statistical support to the Laboratory Operations Drug Product and Stability group through experimental design, statistical analysis, and presentation of results.
Assist in the effective and timely investigation of out-of-specification and out-of-trend data. Assist in determining root causes and suggest appropriate CAPAs.
Review and provide input in investigation reports and annual product review reports.
Monitor release and stability results for developing trends.
Provide statistical analysis of stability data as part of the stability reports.
Provide statistical guidance in analytical method development; suggest improvements to existing methods.
Evaluate equivalency of data sets such as for method transfers, alternate methods, raw material certification, and stability evaluations of alternate configurations.
Training or
Experience:
At least 5 years of pharmaceutical testing experience in a cGMP-regulated laboratory environment.
Pharmaceutical industry statistical experience required
Knowledge of cGMP, USP/NF, ICH, EU and FDA guidelines and regulations.
Excellent oral communication skills and technical writing skills.
Well organized, detail-oriented, and dependable.
Able to assist with troubleshooting analytical methods and laboratory instrumentation (e.g. HPLC, GC, dissolution, wet chemistry).
Expertise in MiniTab, Microsoft Word and Excel. Experience with Stability System Software and SAS preferred.
Demonstrated ability to work as part of a cross-functional team.
Education:
Minimum of a BS Degree in Mathematics, Chemistry or related field.
Kremers Urban offers competitive packages (medical, vision, dental, vacation, paid holidays and 401(k), growth potential, and a challenging and exciting work environment.
Should you have interest in joining our team, feel free to apply to http://www.kremersurban.com/careers/Careers.aspx.
UCB and its subsidiaries encourage diversity in the workplace, we are an Equal Opportunity Employer. Minority/Female/Disability/Veteran.Estimated Salary: $20 to $28 per hour based on qualifications.
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