cGMP COMPLIANCE MANAGER

Job DescriptionJob 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 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.

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