What are the responsibilities and job description for the TEMP QC Specialist II/III position at MedPharm?
Summary of Key Responsibilities:
Qualifications:
- Author or act as reviewer for lab investigations, deviations, protocols and specifications for raw materials an dfinished products.
- Schedule the QC laboratory workload appropriately to meet customer release testing schedules, stability pull dates and timelines.
- Monitor weekly laboratory and data review activities for accuracy and track hours needed for completion of tasks.
- Oversight for review of QC and Stability data for compliance with Customer Requirements and specifications and regulatory requirements
- Interact with third party laboratories for microbial and analytical testing of finished products and raw materials
- Generate and/or review shipping paperwork for third part testing and prepare samples for shipment.
- Create purchase requisitions for lab supplies and third-party testing
- Perform weekly laboratory audit inspections
- Perform sampling of raw materials
- Assist with implementation of the Raman hand-held spectrophotometer for ID testing.
- Review third party laboratory investigations and protocols.
- Provide technical support to the laboratory for method troubleshooting as needed.
Qualifications:
- B.S. in a scientific discipline.
- 5 years’ experience in a Quality Control/Assurance role in the pharmaceutical industry.
- Experience with USP, EP and JP monographs.
- Experience lab applications such as Empower CDS, (UV Spectral, Ion detectors), FTIR, and Particle size Mastersizer.
- Experience with Power BI is a plus
- Experience in Data Review of Analytical data per GDP guidelines.
- Proven ability to review and evaluate the compliance and completeness of analytical data.
- Thorough knowledge of GxP regulations.
- Proven ability to collaborate with technical staff and customers.
- Is thorough when performing work; conscientious about attention to detail; uses logical thinking that is well organized and methodical.
- Able to multi-task productively, applying time management processes and procedures effectively.
- Technically capable of determining what is wrong in complex situations and offering potential solutions, identifying root cause of a problem, and working with others to correct problems.
- Works toward common goals by supporting, encouraging, and sharing information with colleagues.
- Speaks, writes, listens, and presents information in a logical and articulate manner.
