Quality Control Analyst I - III Raw Materials - Methods Validation

Initial Therapeutics, Inc.; West Lebanon (NH); On-site; USD 50,000 - 70,000; Full time

Job summary

Une entreprise biopharmaceutique de renom cherche à renforcer son équipe par un rôle de soutien des opérations de contrôle qualité. Le candidat idéal aura un diplôme associé en sciences, de l'expérience en laboratoire et une solide attention aux détails. Ce poste, basé dans l'usine de West Lebanon, saura apporter un véritable soutien aux opérations de fabrication tout en garantissant la conformité aux règlements de qualité.

Benefits

Leading pay and annual performance bonus

36 paid days off (including vacation, sick days & company holidays)

Health, Dental, and Vision Insurance

Guaranteed 8% 401K contribution plus match option

14 weeks Paid Parental Leave

Free access to Novo Nordisk-marketed pharmaceutical products

Qualifications

• Expérience en laboratoire avec des techniques aseptiques.
• Capacité à suivre et exécuter des instructions écrites.
• Capacité à prioriser les tâches.

Responsibilities

• Effectuer des tests de faible complexité de manière indépendante.
• Exécuter des tests de complexité modérée avec un soutien minimal.
• Participer aux enquêtes et investigations de laboratoire.

Skills

Attention to detail

Good organization

Training ability

Education

Associate’s degree in a scientific discipline

Bachelor’s degree in scientific discipline

Job 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.

What we offer you:

• Leading pay and annual performance bonus for all positions
• 36Paid days off including vacation, sick days & company holidays
• Health Insurance, Dental Insurance, Vision Insurance
• Guaranteed 8% 401K contribution plus individual company match option
• 14weeks Paid Parental Leave
• Free access to Novo Nordisk-marketed pharmaceutical products

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

This position has primary responsibility to support Quality Control operations in the microbiology, analytical or inspection area. This position requires strict adherence to cGMPs, established manufacturing practices and procedures, and compliance with quality regulations and guidelines. This position carries out routine QC testing and may support sampling, investigations, validations, projects and other related support activities for the manufacturing facility and process. This individual works with supervision on routine tasks and detailed instruction on new tasks.

This role is onsite based Monday through Friday, during standard office hours at our West Lebanon, NH bioproduction facility.

Relationships

Reports to: According to the organizational chart

Number of subordinates with direct/indirect referral: n/a

Essential Functions

Independently performs low complexity testing (e.g. Bioburden, Spectroscopy, Environmental Monitoring)

Executes moderate complexity testing with minimal support (e.g. Microbial Identification, HPLC, SDS-PAGE)

Performs high complexity testing with support (e.g. Bacterial Endotoxin, ELISA, UPLC)

Completes routine equipment maintenance/calibration

Supports equipment qualifications or method verification/validation activities

Participates in deviations and laboratory investigations

Update standard operating procedures with help

Delivers training on low complexity tasks

Performs troubleshooting with support

Contributes to cLEAN activities (e.g. PDCA, SPS, VSM)

Lead or support projects with limited scope

Documents and archives work in accordance with Good Documentation Practice

Identifies continuous improvement opportunities

Present standard requests during audit/inspections

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

Other duties as assigned

Qualifications

• Education and Certifications
• Associate’s degree in a scientific discipline required
• Bachelor’s degree in scientific discipline preferred

Work Experience:

Associate’s degree with three (3) years of relevant experience required

Bachelor’s degree with one (1) year of relevant experience preferred

Pharmaceutical, Biotechnology or other regulated industry experience preferred

Knowledge, Skills, and Abilities

Knowledge of laboratory practices required (such as aseptic technique, use of pipettes, pH etc.)

The ability to understand and execute established written instructions is essential

Good organization and documentation skills

Strong Attention to detail

Ability to prioritize tasks

Ability to train others

Physical Requirements

0-5% overnight travel required. The ability to climb, balance, stoop, reach, stand and walk.The ability to push, lift, grasp, and feel. The ability to speak, listen, and understand verbal and written communication. Repetition including substantial movement of wrists, hands, and or fingers. Lifting up to 10 pounds of force occasionally to lift, carry, push, pull, or otherwise move objects. Visual acuity to perform close activities such as: reading, writing, and analyzing; and to determine the accuracy, neatness, and thoroughness of work assigned or to make general observations. The working environment includes a variety of physical conditions including: noise, close proximity to moving parts and equipment, use of ladders, and exposure to chemicals; atmospheric conditions including: Odors, fumes, and dust.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.