Our client – a growing company with multiple plants in the US, needs a Quality Management System (QMS) Specialist at their plant expanding to manufacture pharmaceutical products. Excellent salary + Relocation + Full Benefit Package.
Job Posting # 2655
Job Title: Quality Management System (QMS) Specialist Location: Lawrence, KS
Compensation: Salary of $80K - $100K per year
Relocation: YES - Client offers relo assistance for reasonable expenses
Benefits: Full package for medical, dental insurance, 401K + 13 days - PTO, etc.
Our client is a privately held company with manufacturing sites in CA + KS with around 300 people
Group Info: Be part of the medical device and pharmaceutical contract manufacturing site with around 120+ employees and expected to grow to 150 people. This Quality group has around 25 people from Quality Control, Quality Assurance, Compliance. This person will be responsible for the Technical Administration of Quality Management System – MasterControl and report to the Sr. Dir – Head of Quality.
The new operation expansion is for Pharma Fill Finish Seal – FFS of Sterile Aseptic liquids.
Job Summary:
The company has implemented an QMS software- MasterControl to manage and integrate their quality related functions for Training, Document Control, SOP Management, CAPA, Deviation, Change Control, Audit management, integrated business process management.
This Specialist will be the Administrator of the QMS system providing support to all the users from Quality, Production, Regulatory etc. to utilize effectively.
This incumbent will be a MasterControl SME - Subject Matter Expert
Important implementation will be the SOP’s management to verify users, signing off on the proper steps needed for the process. Batch Control to verify operators are following manufacturing process with proper signoffs, Training to verify all employees are getting properly trained and tracking progress.
Note 1: Extensive years of related QMS administration experience will be considered in place of a BS degree
Note 2: This is a technical software administration role and this person needs experience with other similar QMS system, with MasterControl as a huge plus.
Candidate Must Have:
Bachelor’s Degree or related field.
3+ years of QMS - Quality Management System in Medical Device or Pharma Industry
Flexibility and ability to manage multiple and competing priorities.
Ability to multi-task with strong sense of urgency; ability to meet deadlines.
Some leadership skills to take charge and fully launch the QMS implementation
Excellent attention to detail and capable of performing dependable, accurate work.
Candidate Nice to Have:
- Knowledge of Sterile Aseptic Filling Operations
- Startup or Small company experience working in a dynamic and hands-on role.
- Contract Manufacturing experience working closely with customers and clients
- Work experience with QMS – MasterControl as used by the Company.
Keywords: BioPharma, Pharma, Quality, FDA, QMS, MasterControl, Sterile, CDMO, Manufacturing, Plant.
