WAP C, USA
11 hours ago
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’sWorking 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 activitiesIdentifying and initiating continuous improvement activities in line within the Healthineers Performance System (HPS) frameworkReviewing 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 Technology5-7 years’ experience working in a similar role in the medical diagnostic/ medical device industryStrong 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 accuracyEffective 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 productsWorking knowledge of Lean and other Continuous Improvement philosophies and techniquesProficiency with Microsoft Office applicationsExperience with Mini-tab or other statistical toolsPrior knowledge and use of SAP or similar MRP/ERP system

Who we are: We are a team of more than 73,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.

How we work: When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

To find out more about Siemens Healthineers businesses, please visit our company page here.

The annual base pay for this position is:

Min $93,000 - Max $139,500

Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.

If this is a commission eligible position the commission eligibility will be in accordance with the terms of the Company's plan. Commissions are based on individual performance and/or company performance.

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan. life insurance, long-term and short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time.

Equal Employment Opportunity Statement: Siemens Healthineers is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.

EEO is the Law: Applicants and employees are protected under Federal law from discrimination.

Reasonable Accommodations: Siemens Healthineers is committed to equal employment opportunity. As part of this commitment, we will ensure that persons with disabilities are provided reasonable accommodations.

If you require a reasonable accommodation in completing a job application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please fill out the accommodations form here. If you’re unable to complete the form, you can reach out to our HR People Connect People Contact Center for support at peopleconnectvendorsnam.func@siemens-healthineers.com. Please note HR People Connect People Contact Center will not have visibility of your application or interview status.

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Export Control: “A successful candidate must be able to work with controlled technology in accordance with US export control law.” “It is Siemens Healthineers’ policy to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations.”

Data Privacy: We care about your data privacy (https://www.siemens-healthineers.com/careers/recruitment-application-privacy-notice) and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. We ask instead that you create a profile in our talent community where you can upload your CV. Setting up a profile lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open. Register here to get started.

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