Premium Production
cGMP COMPLIANCE MANAGER
Premium Production, Provo, Utah, us, 84605
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.
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.