QC Supervisor - Raw Materials (RM)

1st Shift: 8:00 am – 5:00 pm, Monday thru Friday

Position Overview

The QC Supervisor – Raw Material (RM) will primarily assist Formulations and Production Departments by scheduling the analyses of pharmaceutical, nutraceutical, or industrial raw material samples delivered to the QC laboratory. Support will be provided by ensuring that samples are analyzed using various procedures including, but not limited to, internal procedures, specifications, and analytical methods; compendia monographs; client procedures; and protocols. Sample analysis will mainly support raw material testing and release. The QC Supervisor – RM is expected to understand internal procedures and establish good laboratory practices. Additionally, the QC Supervisor – RM is expected to assist all Chemists with troubleshooting analyses and equipment as needed.

The QC Supervisor - RM will have a thorough understanding of USP, ICH, and FDA guidelines as they relate to raw material and qualification activities and will perform laboratory investigations (i.e. quality investigations, out of specification investigations, etc.) as necessary.

Essential Job Functions

• Mentors, trains, and supervises the Raw Materials team. Additionally, QC Supervisor - RM will provide input and support to the Finished Product team as needed
• Assists the QC Manager – Commercial in the prioritization of the workload and providing updates in the form of notifications and reports internally and externally
• Communicates with direct reports, co-workers, clients, contract laboratories, and vendors to coordinate all analytical raw material team activities such as quoting, testing, documentation, shipping, purchasing, and billing
• Composes, reviews, and approves: SOPs, analytical methods, material specifications, deviations, and/or out-of-specification investigations
• Formulates, examines, and implements protocols and summary reports related to routine stability studies, method validations, method transfers, and/or method verifications
• Performs and oversees testing involving HPLC, GC, UV analysis, and various wet chemistry procedures
• Assists Level 1-3 Chemists, Associate Scientists, Scientists, and Senior Scientists with tasks
• Maintains awareness of changing regulatory and industry requirements (i.e. USP, FCC, EU, JP, etc.)
• Generates and reviews QC metrics
• Performs data review as needed.
• Participates in laboratory cleaning activities and maintenance.
• Conducts annual performance reviews and meetings
• Follows all Coating Place cGMP practices, policies, and procedures
• Follows all Coating Place safety practices, policies, and procedures
• Employees at Coating Place work with and/or are familiar with the GMP requirements for Food, Dietary Supplements, Pharmaceuticals, or other elements of each.
• Depending on the position, the employee will be aware of Halal and/or Kosher requirements
• Other duties as assigned.

Education/Skills/Knowledge Required

• Bachelor’s degree in Chemistry or related field.
• 3+ years of supervisory experience in a cGMP pharmaceutical environment or a minimum of 3+ years of experience at Coating Place, Inc.
• Thorough understanding of USP, ICH, and FDA guidelines as they relate to qualification activities.
• Bachelor's degree in Chemistry or related field.
• Proven demonstration of supervisory and leadership skills to successfully train, direct, and motivate QC personnel required.
• Advanced time management skills to complete assignments/projects in a timely manner with minimal supervision.
• Ability to establish and maintain effective working relationships with team members, co-workers, vendors, and/or clients.

Competitive Benefits:

• Medical, Dental, Vision, Life, AD&D, and Disability Insurance
• 401K Plan
• Tuition Reimbursement Program
• Paid-time Off - Accrue up to 17 days of PTO within the 1st year!