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