We are hiring a Manager, Quality Control to join our growing team at our BWI/Harmans facility.
The Manager, Quality Control role is critical to our patients. The Manager, Quality Control is responsible for supervising routine QC testing on cleaning, in-process, and release samples. The individual will also assist analytical method transfers and method qualifications between the Analytical Development group and Quality Control (QC). The Quality Control Analytical Manager must demonstrate strong technical knowledge, be familiar with basic scientific/regulatory principles, possess initiative, and maintain a strong commitment to scientific excellence.
Oversight and maintenance of Catalent’s quality control analytical testing program (including assays such as ELISA, DNA/RNA extraction and gel electrophoresis, qPCR, RT-PCR, HPLC / UPLC, and Capillary Electrophoresis)
Oversight of assays such as ELISA, DNA/RNA extraction and gel electrophoresis, qPCR, RT-PCR, ddPCR, HPLC/UPLC, and Capillary Electrophoresis. Performance of these assays by the individual may be required.
Generate internal and external documents such as assay protocols, summary reports, and SOPs
Ensures compliance with cGMP and safety requirements within the QC analytical laboratory
Participates in project-specific, system, client, and vendor audits
Work closely with Manufacturing and Quality Assurance staff to resolve quality issues with regard to the facility and products manufactured
Document writing (laboratory investigations, out of specifications, deviations, CAPAs), data interpretation/presentation, statistical analysis, and trending
Link to job description and application - https://catalent.wd1.myworkdayjobs.com/External/job/Harmans-MD/Manager--Quality-Control_0047628-7
Bachelor’s degree in a Life Sciences discipline or equivalent experience is a minimum requirement 6 or more years of relevant experience and at least 4+ years of people management experience in GMP regulated laboratory preferred
Considerable knowledge/expertise relevant to QC analytical methods used for protein chemistry, separation assays, bioassays and molecular biology
Experience within the biologic, pharmaceutical, or medical device industry performing direct hands-on work in a Quality Assurance/QC function with a strong familiarity of general GMP practices
Experience in writing SOPs and test methods as well as method qualification/validation documentation
About Catalent Pharma Solutions
Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent’s advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? https://www.catalent.com/about-us/overview/