FSQR USP Supervisor

Morton Salt•Grand Saline, TX

1d•Onsite

About The Position

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 we operate, and the world around us. By joining our team, you will contribute to producing and delivering every form of salt that enhances everyday life.

Requirements

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.

Nice To Haves

Supervisory experience preferred.

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.