QC Analytical Scientist Job

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Requisition ID 32237BR
Title QC Analytical Scientist
Job Category Quality
Job Description Novo Nordisk in West Lebanon, NH is looking for a QC Analytical Scientist to oversee, schedule and lead day-to-day Quality Control activities. The person in this role will be responsible 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). The QC Analytical Scientist will also provide QC Analytical training and guidance to Analysts and Technicians. Supply information to cross functional teams about testing timelines and related quality issues.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

* Mentor and lead Analytical team and manage overall workflow
* Schedule and oversee all assays and lab procedures according to and in compliance with cGMP, CFR and/or PTC guidelines and SOPs
* Follow and train analysts and technicians in all general and laboratory SOPs
* Lead method transfer between Denmark facilities and internal departments
* Review and amend test methods and instrumentation SOPs as needed
* Lead laboratory investigations involving assay failures, system deficiencies, deviations, equipment and assay troubleshooting within Quality System.
* Oversee and participate in maintenance, calibration and troubleshooting of equipment
* Conducts data review of results and reports data to Manager, QC
* Communicate with manager and other colleagues re: daily lab activities
* Manage preparation of protocols, final reports, investigations, and deviations
* Update and maintain trending files, and provide routine summaries of trending to support investigations.
* Participate in personnel 3P and 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.
* Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way.
* 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.

PHYSICAL REQUIREMENTS:

* Ability to sit and stand for extended periods of time
* This position requires walking, holding, bending, stooping
* Ability to lift up to 25lbs
* 20/20 vision or ability to wear corrective eye wear to create 20/20 vision

Education/Special training required:

* BS in analytical chemistry, biochemistry or related field with a minimum of seven (7) years related experience or a Master's/PhD with a minimum three (3) years of related experience.

Qualifications/work experience required

* Must have a minimum 2 yrs. experience leading/mentoring scientific staff in a biotech/pharmaceutical analytical laboratory with demonstrated ability to develop scientific staff.
* Working knowledge of cGMPs and industry experience.
* Technical expertise in protein analysis using HPLC, SEC, ELISA, IEF.
* Experience with method qualification, validation and technology transfer.
* Experience with Quality Systems such as change control, document root cause analysis
* Excellent analytical and writing skills are also required with the ability to author/review scientific and technical reports.

Department Quality Control
Position Location US - Lebanon, NH
City West Lebanon
State/Provinces US - NH
Novo Nordisk is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law.
Novo Nordisk will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.
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