|Date Posted||November 13, 2020|
|Address||645 Science Drive|
A career with MilliporeSigma is an ongoing journey of discovery: our 57,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.
The Quality Control Environmental Monitoring Supervisor will manage the QC environmental monitoring team. Reporting to the Head of Quality Control, the Quality Control Supervisor will develop and manage the sites’ environmental monitoring program for a Contract Manufacturing Organization (CMO) of Active Pharmaceutical ingredients (API).
In addition, this QC supervisor will oversee the management of the raw material qualification program to ensure that materials are qualified in compliance with cGMP and other appropriate regulations and standards as appropriate for Active Pharmaceutical ingredient (API) manufacture.
The Supervisor Quality Control possess detailed knowledge of cGMP. Highly developed interpersonal, written and verbal skills, including the ability to design, develop and improve the environmental monitoring program. This individual will establish strong collaborative relationships with all departments to deliver on quality and regulatory commitments and have the ability to work autonomously, effectively manage time and deliver results on time. Travel occasionally to other Merck sites for training and benchmarking.
- Leading and developing a team of qualified professionals to manage all quality control aspects of the environmental monitoring program to ensure that process and procedures are in compliance with cGMP for API manufacture in a contract manufacture organization.
- Collaborating with customers to determine the appropriate environmental monitoring strategy for the site and customer specific projects.
- Selection of analytical and sampling methods appropriate to the processes and site to meet appropriate environmental controls.
- Compilation, development and execution of associated trend reports and qualification documentation in line with cGMP standards.
- Demonstrating the ability to provide leadership and organize departmental staff to meet deadlines without compromising quality.
- Ability to provide supervisory oversight in the areas of release, in-process, stability and raw material analyses, as needed, to support to overall Quality Control Unit.
- Ability to stand, sit, walk, bend, reach, lift, pull, push, speak, hear, and use hands to operate lab-testing equipment on a regular basis. Using safety glasses/goggles/face shield, gloves, lab coat, safety shoes and other personal protective equipment.
Who you are:
- Bachelor of Science or Arts in Microbiology, Chemistry or related Life Science field
- 5+ years’ experience in a Quality Control environment
- Experience in a cGMP pharmaceutical quality control lab environment.