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Sr. Quality Control Analytical Scientist

Fitchburg, WI 53711

Posted: 01/25/2023 Employment Type: Direct Hire/Perm Job Category: Scientific Job Number: 528673 Is job remote?: No Country: United States

Job Description

JOB OBJECTIVE: Develop, characterize, validate, and implement analytical methods for the manufacture of Active Pharmaceutical Agents (API).


1. Independently perform and oversee all aspects of analytical method development, method validation and method implementation.
2. Write, review and revise, as necessary, inspection plans, test methods, SOPs and other QC department procedures, for accurate and complete content, and ensuring they meet documentation policy.
3. 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.
4. Collaborate with Manufacturing and R&D to develop analytical methods for API manufacturing.
5. Perform laboratory investigations for Out of Specification results or other testing abnormality. Investigate complaints from customers and internal deviations/nonconformances as assigned.
6. 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.
7. Prepare and/or maintain QC testing materials, retention samples, and reference standards.
8. Maintain a working knowledge of QC Lab instrumentation and associated analytical methods utilized for product release testing.
9. 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.
10. Support internal and external customers to ensure that proper and timely execution of all aspects of the clinical analytical method life cycle.
11. Provide training on QC methods and instrumentation in the laboratory, as needed.
12. Demonstrates inclusion through their own words and actions and is accountable for a safe workspace. Acts with kindness, curiosity and respect for others.
13. Embraces and is open to incorporating the 6 Emotional & Social Intelligence (ESI) core principles in daily work.
14. Understands and complies with ethical, legal and regulatory requirements applicable to our business.


1. Master’s or Ph.D. degree in Analytical Chemistry. M.S. with 10+ years, or Ph.D. with 8+ years in a Quality Control lab performing method development, validation and implementation related to API testing.
2. Extensive knowledge on the use and troubleshooting of typical analytical instruments, including HPLC, NMR, GC, ICP-MS, MS/QToF, Karl Fisher, and XRPD.
3. Experience in all aspects of analytical method development, method validation and method implementation related to API testing. This includes experience with the use of statistical tools to analyze data.
4. Experience writing and reviewing Inspection Plans, test methods, SOPs and other QC Dept procedures, for accuracy and complete content, and ensuring they meet documentation policy.
5. Strong knowledge of current regulatory guidelines and cGMP requirements.


1. Ph.D. with 2+ years or M.S. with 8+ years’ analytical method development experience in pharmaceutical company.
2. Experience in preparing regulatory submissions and responding to regulatory inquiries.


1. Ability to remain stationary for several hours at a time.
2. Ability to move about the building and labs while performing the tasks described above.

Salary Range: 109-164k/yr. Salary will be commensurate with experience
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