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Qc Supervisor

4 months ago

West Lebanon, United States Novo Nordisk Full time

**About the Department**

Site New Hampshire, located in West Lebanon, is where Novo Nordisk’s life-saving treatments are brought to life. Our manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well as our next generation of cutting-edge medications. It’s not your average production site - it’s a tight-knit, supportive community working together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a patient-focused mindset guides everything we do. We’re looking for individuals who are self-starters with a strong work ethic to join our team. At Novo Nordisk, you will find opportunities, resources and mentorship to grow and build your career. Are you ready to realize your potential?

**The Position**

Oversee, schedule and lead day-to-day QC Microbiology activities for routine in-process and product testing ensuring compliance, accuracy and timeliness of testing processes in compliance current Good Manufacturing Practices (cGMP), Code of Federal Regulations (CFR) and/or Points to Consider (PTC) guidelines and Standard Operating Procedures (SOPs). Ensures quality control activities are aligned with industry, regulatory and corporate practice. Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions, while maintaining a high level of compliance with cGMP.

This position is based onsite at our West Lebanon, NH bioproduction facility. Relocation assistance is available for this role.

**Relationships**

Reports to: QC Manager

Number of subordinates with direct/indirect referral: 5-10

**Essential Functions**
- Oversee microbial identification program
- Responsible for introduction of new technology/equipment as needed
- Supervises and mentors microbiology team
- Participates in the review of microbiological trending data and writing reports to summarize trends
- Investigates and resolves issues related to assay failures, system deficiencies, deviations, and equipment/assay troubleshooting
- Performs peer data and report reviews as needed
- Oversees the scheduling of laboratory work
- Review and amend test methods and instrumentation SOPs as needed
- Updates and maintains trending files, and provides routine summaries of trending to support investigations
- Assists with other routine laboratory investigations including analyst training
- Determines methods and procedures on new assignments as required
- Other duties as assigned
- Signature Authority and responsibilities:

- QC FAM approval authority within RAM and for all work order processing activities
- QC FAM approval authority related to training (including ELITE), card access and contractor management
- PO and invoice approvals within Supervisor approval authorization limit and within established time expectations
- Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes
- Incorporates the Novo Nordisk Way and 10 Essentials in all activities and interactions with others

**Development of People**
- Ensure that reporting personnel have individual development plans (IDP), with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process.
- Ensure that the IDP forms include completed learning and aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility.

**Qualifications**
- Education and Certifications:

- A Bachelor’s degree in Microbiology, biological sciences or related field
- Work Experience:

- Minimum of three (3) years progressive QC experience or a Masters/PhD with a minimum one (1) years progressive QC experience
- Experienced in a QC GMP laboratory environment
- Knowledge, Skills, and Abilities:

- Advanced knowledge in microbiology concepts and objectives and how they fit into the overall manufacturing process. Knowledgeable and proficient in the following: bioburden, endotoxin, microbial identification and industry environmental monitoring requirements/guidelines
- Must be able to work independently in a team based setting under mínimal instruction/guidance
- Work cross functionally to maximize efficient use of resources
- Troubleshoot and solve technical problems of a broad scope
- Able to prioritize routine tasks and adapt to a changing environment
- Excellent analytical and communication skills

**Physical Requirements**

0-10% overnight travel required. The ability to climb, balance, stoop, crouch, reach, stand, and walk. The ability to push, pull, lift, finger, and grasp. The ability to speak, listen, and understand verbal and written communication. Repeti