Qc Supervisor - West Lebanon, United States - Novo Nordisk

Novo Nordisk

Verified Company

West Lebanon, United States

1 hour ago

Posted by:

Mark Lane

beBee recruiter

Description

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