What are the responsibilities and job description for the cGMP COMPLIANCE MANAGER position at Premium Production?
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, 7:00 a.m. to 4:00 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.
Salary : $27 - $29
