FSQR USP/ Lab Supervisor

Morton-Salt; Rittman (OH); On-site; USD 65,000 - 90,000; Full time

Job summary

Morton Salt is seeking a QA professional to support FSQR activities related to USP products at the site level, ensuring FDA and regulatory compliance and driving continuous improvement across systems and processes.

This role serves as backup to the FSQR Supervisor and Manager, overseeing USP laboratory testing, calibration, and training while maintaining product safety and integrity in a fast-paced plant environment.

Qualifications

• Bachelor’s degree in Chemistry, Biology, Food Science or related field.
• 2+ years in USP/pharma manufacturing or quality lab.
• Knowledge of 21CFR 210, 211 and ICH Q7.
• Supervisory experience preferred.

Responsibilities

• Ensure USP specifications and regulatory compliance at the site.
• Support USP investigations, root cause analyses, and CAPAs.
• Assist USP regulatory and customer audits.
• Oversee USP laboratory testing, release, and GLP programs.
• Review USP trends and related SOPs/forms.

Skills

Self-motivated

Independent work

Communication skills

Team collaboration

Education

Bachelor’s degree in Chemistry/Biology/Food Science

Tools

Laboratory equipment

Job description

Morton Salt is an iconic company with a strong heritage and a bright future. Since 1848, we have been improving lives and enhancing everyday moments – at home, at work and virtually everywhere in between. We help unlock the flavors in food, make roads and sidewalks safer, improve the water in baths, pools, and homes, and keep businesses and industries running. We are a dedicated team who constantly strives to do better together, and we are passionate about building a sustainable future for our company, the communities in which weoperate, and the world around us. By joining our team, you will contribute to producing and delivering every form of salt that enhances everyday life.

Job Summary

This position is responsible for supporting all FSQR activities related to the USP products and programs at the site level. It serves as a back up to the FSQR Supervisor and FSQR Manager for all applicable areas within Quality and Food Safety to ensure that we satisfy our customers, comply with corporate and local/state/federal legal and regulatory requirements, and continuously improve our systems, processes, and culture. Ensures product safety, integrity, legality, quality, and authenticity of all products produced with a targeted focus on USP and FDA drug regulatory compliance.

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.
• Support the regular reviews of the facility’s GMP Compliance, Prerequisite Programs, Housekeeping and USP Compliance.
• Clear communication with FSQR Manager when facility related USP incidents occur.
• Oversight of USP related instruction, inspection, testing and approval following maintenance and repair work.
• Review of COAs for accuracy and distribution as applicable.
• Generation, review and revision of USP related SOPs and forms.
• Review of USP related work orders.
• Assist with new hire and annual USP training.
• Calibration and capabilities of USP lab equipment.
• Review and identify USP trends, including all USP reporting requirements.
• Day to day supervision and scheduling of USP Technicians.
• Responsible for coordinating USP testing schedule with operations.
• Lead USP validation studies for the site.
• Ordering 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.
• Ability 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.
• Regularly required to sit or stand, reach and move about the facility.
• Work performed in a plant environment.

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.

At Morton Salt, we work best when we work as a team, when we treat one another with dignity and respect, and value the unique contributions of others. We are committed to equal employment opportunity and prohibit discrimination and harassment based on race, national origin, sex, religion, color, disability, marital status, protected veteran status, sexual orientation, gender identity, gender expression, genetic information, citizenship, or any other characteristics protected by law.

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Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.