FSQR USP Supervisor

Morton Salt•Rittman, OH

21h•Onsite

About The Position

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.

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.
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.

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.