cGMP COMPLIANCE MANAGER

Job Description

Premium Production is a manufacturing company building a team to help change the world.

We are looking for a full-time cGMP Compliance Manager to join our team in Hildale, Utah. You will be responsible for managing an efficient team that produces high-quality results while in compliance with all regulations from all governing federal and state bodies.

What you will do:

Directly supervise all team members in the cGMP Compliance Section

Effectively delegate assignments in a clear and concise manner

Write detailed reports on findings and recommended solutions

Ensure all safety and sanitation rules are being followed and documented

Create and revise SOPs for various areas as needed

Ensure all your team members are trained and proficient in their roles

Perform internal audits on all departments to ensure compliance with FDA standards

Perform and train team members to do environmental and allergen testing as applicable

Analyze current processes to identify inefficiencies, bottlenecks, and areas for improvement

Design and implement process improvement strategies using Lean, Six Sigma, or other methodologies

Monitor the performance of team members and provide feedback to them

Create an environment where people take action by themselves

Set and successfully achieve section goals

Go over Standard Checklists and oversee corrections take place

Ensure all trackers are updated and maintained

Enforce standards, policies, and quotas with the team and makes corrections when necessary

Complete interviews for potential team members under your supervision

Accurately maintain all documentation

What we prefer you to bring:

Experience in quality management and auditing

2+ years of experience in CGMP compliance within the pharmaceutical, biopharmaceutical, or medical device industry

What you must bring:

Physical requirements:

Must not be significantly allergic to soy, fruits, vegetables, fibers, and spices

Must not be color blind

High school diploma or GED required

Minimum 1 year required of experience in cGMP compliance within the pharmaceutical, biopharmaceutical, or medical device industry

Previous experience in managing regulatory inspections

Demonstrated experience with regulatory inspections, internal/external audits, NCR and CAPA processes

Knowledge of cGMP and Allergen Control

Knowledge of OSHA and FDA regulations, specifically 21 CFR Part 111

Strong analytical skills and the ability to interpret and apply complex regulatory requirements

Familiarity with Standard Operating Procedures and Quality Management Systems (QMS)

Knowledgeable about and able to comply with high hygiene expectations

Excellent written and verbal communication skills

Pay: $27.00 to $29.00 per hour

Schedule: Monday through Friday, 8:00 a.m. to 5:00 p.m. Flexibility as needed

Job Type: Full-Time, In-Person

Why you’ll love working here:

401(k) with a 6% employer match

Minimum Essential Coverage insurance plan

Health Savings Account

Health Share Program

Dental & Vision Insurance

Complimentary monthly set of Balance of Nature supplement products

Personal trainers at Iron Titans Fitness in St. George, Utah

Thank you for your interest in working with Premium Production!

Premium Production is an equal opportunity employer.

#ZR

Full-time