FSQR USP/ Lab Supervisor

About the role

This position supports all Food Safety, Quality, and Regulatory (FSQR) activities related to the USP products and programs at the site level. It serves as a backup to the FSQR Supervisor and FSQR Manager for all applicable areas within Quality and Food Safety to ensure customer satisfaction, compliance with corporate and regulatory requirements, and continuous improvement of systems, processes, and culture. The role ensures product safety, integrity, legality, quality, and authenticity with a targeted focus on USP and FDA drug regulatory compliance.

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.
• Support and back up the FSQR Manager during all USP regulatory and customer audits.
• Support the Quality and Food Safety culture at the site.
• Oversee FSQR USP laboratory testing, release, and GLP programs.
• Support regular reviews of the facility’s GMP Compliance, Prerequisite Programs, Housekeeping, and USP Compliance.
• Maintain clear communication with the FSQR Manager regarding facility-related USP incidents.
• Oversee USP-related instruction, inspection, testing, and approval following maintenance and repair work.
• Review Certificates of Analysis (COAs) for accuracy and distribution as applicable.
• Generate, review, and revise USP-related SOPs and forms.
• Review USP-related work orders.
• Assist with new hire and annual USP training.
• Ensure calibration and capabilities of USP lab equipment.
• Review and identify USP trends, including all USP reporting requirements.
• Provide day-to-day supervision and scheduling of USP Technicians.
• Coordinate the USP testing schedule with operations.
• Lead USP validation studies for the site.
• Order necessary supplies and equipment for USP testing.

Requirements

• Bachelor’s degree in Chemistry, Biology, Food Science, or other related science field is required.
• Minimum of 2 years of 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.

Skills

• Highly self-motivated, high energy, and ability to work independently as well as a team contributor and collaborator.
• Ability to show initiative and drive positive change in systems, 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 and communication skills, with the ability to manage conflict in a stressful environment.
• Ability to work with cross-functional teams and under pressure in a fast-paced and challenging site environment.
• Ability to effectively communicate and present information to all levels within the organization, as well as internal and external staff, government authorities, auditors, customers, and vendors, occasionally under urgent or high-pressure conditions.
• Strong interpersonal skills and excellent verbal and written communication skills.
• Regularly required to sit or stand, reach, and move about the facility.
• Work performed in a plant environment.