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QC Supervisor

Location : Le Sueur, MN
Hours : Full Time
Travel : No
Relocation : No

Job Description :
Our client is a Leading global manufacturer and distributor of animal health products and veterinary pharmaceuticals.



Connect with us to learn more about this great opportunity – QC Supervisor!  

 


 


In this role you will supervises a department of 6 analysts, technicians and 1 microbiologist to assure materials are tested on-time and according to cGMP.



  • Approval, supervision, and scheduling of laboratory personnel

  • Conduct or assist in periodic audits of contract testing laboratories

  • Interacts w/ Regulatory Authorities during plant inspections regarding QC laboratory issues

  • Scheduling, testing, and approval of excipients, API’s, and finished products

  • QC Supervision of laboratory activities, including tracking/purchasing of laboratory chemicals

  • Inventory control of stability samples, finished product samples, and raw material samples

  • Responsible for providing QC laboratory support to production

  • Review and approve of quality documents

  • Coordination and maintenance of stability program

  • Trend analysis of product testing and stability testing

  • Coordinating of out-of-specification investigations and deviation investigations

  • Develop Standard Operating Procedures and Test Methods for Quality Control (QC) activities and functions

  • Periodic monitoring and verification of laboratory personnel to ensure compliance to written procedures and/or regulatory requirements

  • Review and/or approval of excipients and APIs to be issued to production

  • Provide training on procedures and methods, as needed

  • Provide additional support to QA Director, as needed

  • Review of batch records for compliance of manufacturing processes/steps, ensuring that all applicable documents, records, and forms are completed and attached

  • Responsible for analytical method transfers for contract manufacture

  • Responsible for USP method verification protocols and reports


Required Qualifications :


  • Bachelor’s Degree in a related science field

  • 4 + years of Analytical Chemistry experience

  • Direct knowledge of QC methodologies

  • Previous experience in an FDA, Canadian Health, and or EU regulated Pharmaceutical manufacturing environment – A Plus!

  • Previous Supervisory / Leadership experience – A Plus!

  • Previous Supervisory training – A Plus!

  • Knowledge and experience w/ continuous improvement programs – A Plus!

  • Previous experience with root cause analysis – A Plus!

  • Working knowledge and troubleshooting of HPLC, UV/VIS, GC, and dissolution

  • Knowledge of microbiology testing and assay - A Plus!

  • Excellent communication skills for liaising and communicating with vendors, customers, and internal departments

  • Strong problem identification and problem resolution skills

  • Proficient with Microsoft Office Products

  • Ability to quickly assess the compliance risk of events and make decisions that are scientifically sound, compliant to the regulations and defensible

  • Skills to be successful – Leadership skills, highly motivated, self-directed, multi-tasker, detail oriented, analytical thinker, Problem solver, passionate, strategic thinker, and the ability to work with minimal supervision

  • Collaborative Team Player and positive team attitude, relationship builder


 

 

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