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Sr Quality Control Analytical Scientist

Company: Promega
Location: Madison
Posted on: September 13, 2020

Job Description:

JOB OBJECTIVE: Develop, characterize, validate, and perform analytical methods for current and new products for a company that manufactures small molecules, particles, and polymers used in medical devices.

This position will be located at Promega's new Component Manufacturing Center facility in Fitchburg. Please click on the link to find more information regarding this facility's functionality (CMC Building ).

ESSENTIAL DUTIES:

1. Perform analytical method validation and characterization when required to support process improvement, product transfer, or new product realization projects.

2. Ability to independently perform all aspects of method development and method validation. Product and raw material testing would also be a function of this position.

3. Develop reports, protocols, and SOP’s for new and current analytical methods.

4. Mentor & train Junior scientists and aid when needed in high throughput times of intermediate testing, final product, and raw materials.

5. Maintain a working knowledge of QC Lab instrumentation and associated analytical methods utilized for product release testing. Perform analytical method evaluation and/or re-validation upon request, as part of Installation / Operation / Performance Qualification efforts related to new or changed laboratory instrumentation.

6. Evaluate and interpret analytical testing results. Act as primary reviewer of analytical data generated from raw materials test, In process testing, and final product testing.

7. Perform laboratory investigations for Out of Specification results or other testing abnormality. Investigate complaints from customers and internal deviations / nonconformances as assigned.

8. Develop and maintain a product/intermediate stability program.

9. Report results of release testing according to company Quality System requirements. This includes the input of results into SAP Quality Module and issuing COA’s as needed.

10. Prepare and/or maintain QC testing materials, retention samples, and reference standards.

11. Write, review and revise, as necessary, Inspection Plans, test methods, SOPs and other QC Dept procedures, for accurate and complete content, and ensuring they meet documentation policy.

12. Provide training on QC methods and instrumentation in the laboratory, as needed.

13. Understands and complies with ethical, legal and regulatory requirements applicable to our business.

MANDATORY QUALIFICATIONS:

1. Degree in Chemistry or related lab science. MS with 2-4 years, or BS with 4-7 years direct experience in a Quality Control lab using advanced equipment and techniques. Extensive experience in method validation.

2. The ideal candidate will have extensive knowledge on the use and troubleshooting of typical analytical instruments. These include GC, ICP-OES, LC-MS, HPLC, NMR, Extinction Coefficients, and Karl Fisher.

3. Candidate will have a working knowledge of and the ability to determine solubility, viscosity, TGA Fluorescence, mass, and conductivity.

4. Knowledge with basic descriptive statistics such as mean, standard deviation, confidence intervals, and linear regression. Experience with use of statistical tools to analyze data.

5. The ideal candidate will have a proven track record in the design of new and existing product method validation.

PREFERRED QUALIFICATIONS:

1. MS with 5-7 years experience in method development and validation using HPLC, Mass Spectrometer, LC-MS, NMR, ICP-OES, GC, NMR, Spectrophotometers or Luminometers.

2. Experience in a small molecule pharmaceutical API manufacturing environment.

3. Experience or familiarity with ISO9001 and/or cGMP requirements.

3. Independent, self-starter with proven results in problem identification, planning, communication and project management.

4. Desire for future growth into QC department leader/Supervisor.

5. Organizational and multi-tasking skills; able to manage several tasks simultaneously.

PHYSICAL REQUIREMENTS:

1. Must be able to move about the building and labs while performing the tasks described above.

2. Must be able to stand for long periods.

3. Must be able to identify and distinguish colors.

4. Ability to work with chemical reagents required for analytical testing.

5. Must be able to wear appropriate personal protective equipment such as lab coat, mask, gloves and safety glasses.

6. Ability to move objects averaging 10 pounds.

7. Ability to travel.

8. Must be able to use a computer for extended periods of time throughout the day.

Diversity is important at Promega. We are proud to be an Equal Opportunity Employer, and make employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected class.

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Keywords: Promega, Madison , Sr Quality Control Analytical Scientist, Other , Madison, Wisconsin

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