FSQR USP/Lab Supervisor

Duties And Responsibilities

• Ensure compliance with USP specifications, customer, and regulatory requirements at the site.
• Support the USP customer complaint investigations process, including conducting root cause analysis and driving corrective action plans, up to and including into manufacturing processes and/or product specification(s).
• Support and back up the FSQR Manager during all USP regulatory and customer audits.
• Supports Quality and Food Safety culture at the site.
• Oversees FSQR USP laboratory testing, release and GLP programs.
• Safeguards the facility’s GMP Compliance, Prerequisite Programs, Housekeeping and USP Compliance.
• Clear communication with FSQR Manager when facility related USP incidents occur.
• Oversees oversight of USP related instruction, inspection, testing and approval following maintenance and repair work.
• Reviews COAs for accuracy and distribution as applicable.
• Generates, reviews and revises USP related SOPs and forms.
• Reviews and identifies USP trends, including all USP reporting requirements.
• Coordinates USP testing schedule with operations.
• Leads USP validation studies for the site.
• Orders necessary supplies and equipment for USP testing.

Skills, Knowledge And Abilities

• Highly self-motivated, high energy and ability to work independently and team contributor and collaborator, show initiative, and drive positive change in system, processes, and culture.
• Ability to understand and comply with all company policies and procedures as well as all applicable local/state/federal regulations.
• Well-developed interpersonal, communication skills and able to manage conflict in a stressful environment.
• Able to work with cross-functional teams and ability to work successfully under pressure in a fast paced and challenging site environment.
• Ability to effectively communicate and present information to all levels throughout the Morton Salt organization as well as internal and external staff, government authorities, auditors, customers, vendors, occasionally under conditions of urgency and in pressure situations.
• Strong interpersonal skills, and excellent verbal and written communication skills.

Position Qualifications

• Bachelor’s degree in Chemistry, Biology, Food Science or other related science field is required.
• Minimum of 2 years experience working in a USP / pharma manufacturing environment or quality laboratory.
• Strong knowledge of 21CFR 210, 21CFR 211, ICH Q7 or other applicable pharma regulations.
• Supervisory experience preferred.