Raw Materials Supervisor

Quality Seymour, Indiana


Description

Job Summary:

This position is primarily responsible for supervision of the daily operations of a team of raw material chemists and technicians. These activities primarily consist of the laboratory support for all incoming materials (i.e. raw materials, packaging materials) and chemical testing of cleaning validation samples.

Essential Functions:

  • Supervise the daily activities of team members to provide timely and efficient testing of raw materials, packaging materials (i.e. incoming, retest) and chemical cleaning validation samples according to current analytical procedures, SOPs and laboratory guidelines.
  • Ensure that the laboratory testing techniques and documentation of each assigned analyst comply with GMPs, SOPs, and is of the highest integrity and accuracy.
  • Provide testing completion dates to the QC manager and promptly communicate any schedule changes.
  • Establish and maintain material-specific testing times.
  • Perform effective and timely investigations of out-of-specification and out-of-trend data and communicate to manager and affected departments. Determine root causes and suggest appropriate CAPAs.  Review investigation reports.
  • Critically review data and reports generated by the raw material group.
  • Ensure compliant laboratory operations and documentation.
  • Monitor metrics or KPIs and communicate information and recommendations to QC Manager.
  • Maintain compliance with SOPs, USP/NF, FDA, GMP, and OSHA regulations for the raw material laboratory functions.
  • Ensure compliance with Field Alert Reporting requirements.
  • Be a technical resource for the raw material team.
  • Communicate with other departments and contract labs to coordinate activities.
  • Ensure that all necessary information is entered into the appropriate databases for trending and capacity modeling purposes.
  • Provide technical reviews and data comparisons to maintain the raw material certification program.
  • Assist in the evaluation and improvement of departmental SOPs, testing procedures, and specifications.
  • Participate in analytical method transfers to QC from the AD group.
  • Identify and gather quotes for laboratory capital equipment for the raw material group.
  • Maintain and improve laboratory efficiency and quality by implementing improvements, new techniques, training, and new processes.
  • Supervise work to ensure the use of appropriate safety measures and appropriate techniques to ensure the integrity of the data.
  • Handle personnel responsibilities including interviewing, hiring, performance reviews, disciplinary action, goals/objectives, rewards, coaching, training, etc. Appropriately document employees’ performance and provide corrective actions or training.
  • Assist in special projects or other tasks as deemed necessary based on personal qualifications, business needs and QC management’s discretion.

Training or Experience:

  • At least 5 years of pharmaceutical testing experience in a GMP-regulated laboratory environment.
  • Prior supervisory experience preferred
  • Able to troubleshoot analytical methods and laboratory instrumentation (e.g. HPLC, GC, FTIR, UV/Vis, physical chemistry, wet chemistry).
  • Experience with Chromatography Data Acquisition Systems and Laboratory Information Systems.
  • Knowledge of GMP, USP/NF, ICH, DEA, EU and FDA guidelines and regulations.
  • Excellent oral and written communication skills.
  • Expertise in Microsoft Word and Excel.
  • Strong troubleshooting and investigation skills.
  • Demonstrated ability to work as part of a cross-functional team.

Education:

  • Minimum of a BS Degree in Chemistry or a related field

 

Supervises/Manages:

  • Supervise raw material team leader, chemists (currently 6) and technician