Quality Control SupervisorQuality ControlUnion County , NJ, US
Added - 13/11/2024
Apply for JobResponsibilities:
Supervise and conduct quality control testing, and manage stability records and related documentation.
Lead method development, training, and method transfers to and from the QC department and external manufacturers.
Modify and validate analytical procedures to support QC requirements.
Design and implement experimental protocols and write SOPs in line with cGMP/GLP standards.
Perform all necessary QC chemical testing for batch release intended for patient use.
Participate in and lead departmental meetings and special projects, contributing through feedback and task execution.
Address analytical and equipment troubleshooting during project execution.
Conduct timely radioactive and microbiological QC testing, maintaining thorough quality records.
Operate, adapt, and maintain analytical instruments effectively.
Ensure the lab environment adheres to safety and pharmaceutical regulations.
Perform tasks related to radiation safety according to regulatory standards.
Report monthly on QC supply needs, including equipment and reagents.
Support routine maintenance and contribute to qualification and validation efforts for R&D and industrial needs.
Lead investigations and perform root-cause analysis for laboratory issues.
Prepare chemical reagents needed for QC and production processes.
Required Education and Qualifications:
Minimum of 5 years’ experience in a GMP QC lab environment, with proven leadership responsibilities.
Strong organizational skills are essential.
Bachelor’s degree in Chemistry or Biochemistry.
Hands-on experience with analytical techniques such as High-Performance Liquid Chromatography (HPLC) and radio-Thin Layer Chromatography (rTLC).
Outstanding communication skills (both oral and written), as well as organizational and problem-solving abilities, especially under tight deadlines.
Ability to simplify complex ideas for both management and clients and make independent decisions during method development/transfer processes.
Solid understanding of current analytical methods used for the testing, release, and stability of sterile pharmaceuticals.
Collaborative team player with a demonstrated ability to work with cross-functional teams.
Proficiency with Microsoft Word and familiarity with laboratory information management systems (LIMS).
INDBHWe are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.