Senior Supervisor - Standards & Controls

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.

Reporting to the Senior Manager of Manufacturing, the primary functions of this individual are to; supervise Standards and Control Manufacturing Technicians and Biochemists, maintain cGMP compliance and adherence to site SOP’s, provide technical guidance to Manufacturing Technicians, and to represent Standards and Control Manufacturing as a Subject Matter Expert (SME) in cross-functional team meetings.

The Standards and Control Manufacturing Senior Supervisor (Bulk Standards and Controls) position plays a key role for the Standards and Control Manufacturing team at the Siemens East Walpole facility. This position reports into the Senior Manager of Manufacturing. 

This position includes the handling of all types of materials, including hazardous and DEA (Drug Enforcement Agency) controlled materials.

This is a role well suited to an ambitious professional, looking for the next step in their career. As a Senior Supervisor, in Standards & Controls Lab, they will be responsible for:

• Supervising Standards and Control Manufacturing Technicians and Biochemists.
• Maintaining cGMP compliance and adherence to site SOP’s.
• Providing technical guidance to Manufacturing Technicians.
• Representing Standards and Control Manufacturing as a Subject Matter Expert (SME) in cross-functional team meetings.
• Auditing manufacturing documentation including Manufacturing Batch Records, Bills of Materials, Routings, Process Documents and SOP’s
• Working with Standards and Controls Manufacturing Biochemists to coordinate and monitor day to day assignments of a group of Manufacturing Technicians.
• Providing training to qualify technicians for manufacturing activities
• Identifying and initiating continuous improvement activities in line within the Healthineers Performance System (HPS) framework
• Reviewing and approving Manufacturing Technician Time Cards and PTO requests and ensures adequate staffing to meet scheduled demands.
• Representing Standards and Control Manufacturing in cross functional meetings including, design element teams, planning and scheduling, and product troubleshooting projects.  
• Authoring, Reviewing, and Approving Quality System documentation including but not limited to Quality Notifications (QN’s), Temporary Manufacturing Deviations (TMDs). Corrective and Preventive Actions (CAPA’s) and Change Impact Assessment (CIA’s)
• Back-filling on the manufacturing floor to meet work center demands

Required Knowledge/Skills, Education, and Experience:

• BS in Life Science discipline: Biology, Chemistry, Medical Technology
• 5-7 years’ experience working in a similar role in the medical diagnostic/ medical device industry
• Strong understanding of cGMP manufacturing in a controlled environment, as well as an understanding of ISO requirements.
• Excellent organization and time management skills; ability to meet multiple commitments, for both the daily manufacturing deliverables, as well as the mid to long term projects.
• High attention to detail and commitment to accuracy
• Effective communication skills, both verbal and in written form. The ability to communicate is critical to the successful delivery of information to customers and the team, with regards to priorities and expectations.
• Experience working with automated manufacturing equipment.
• Solid understanding of the use of laboratory equipment used in bulk manufacturing and witnessing manufacturing batch records.
• Experience doing troubleshooting and investigation work, as well as associated outcomes.
• Ability to present information in technical or scientific writing format.
• Experience in presenting data in table and graphic charts in Excel.
• Must pass a Drug Enforcement Agency (DEA) background check

Preferred Knowledge/Skills, Education, and Experience

• Prior experience manufacturing commercialized automated immunoassays and/or ELISA and chemiluminescent products
• Working knowledge of Lean and other Continuous Improvement philosophies and techniques
• Proficiency with Microsoft Office applications
• Experience with Mini-tab or ot