Quality Assurance Area Specialist I

Initial Therapeutics, Inc.; West Lebanon (NH); On-site; USD 60,000 - 100,000; Full time

Benefits offered by this job

Leading pay and annual performance bonus

36 Paid days off

Health, Dental, and Vision Insurance

8% 401K contribution

14 weeks Paid Parental Leave

Free access to pharmaceutical products

Job summary

An established industry player is seeking a Quality Assurance professional to ensure compliance with in-house specifications and GMP standards. This exciting role involves reviewing documentation, participating in audits, and collaborating with manufacturing teams to resolve compliance issues. The successful candidate will have a strong background in quality assurance, particularly within the pharmaceutical or biotechnology sectors. Join a company dedicated to innovation and excellence, where you can grow your career and contribute to life-saving treatments. This is a fantastic opportunity to make a significant impact in a dynamic environment.

Qualifications

• Bachelor’s degree required; scientific discipline preferred.
• 1+ year of QA experience in pharmaceuticals or biotech.

Responsibilities

• Review manufacturing records for compliance with specifications.
• Participate in audits and assist in regulatory inspections.
• Work with Manufacturing and Quality Control to resolve issues.

Skills

Excellent written communication

Excellent verbal communication

Negotiating skills

Judgment within defined practices

Planning and organization skills

Education

Bachelor’s Degree in a 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
• 36 Paid days off including vacation, sick days & company holidays
• Health Insurance, Dental Insurance, Vision Insurance
• Guaranteed 8% 401K contribution plus individual company match option
• 14 weeks 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 will review manufacturing and support documentation and records to certify compliance with in-house specifications/standards and GMP for all NNUSBPI products. This position has QA signature authority on the review of individual batch records, supporting test records and other ancillary support records. Will assist in the internal audit program and be a QA presence on the manufacturing floor.

Essential Functions

• Participate in walk through audits of NNUSBPI Manufacturing facilities
• Review and assess Corrective and Preventive Actions
• Reviews and approves validation documentation
• Reviews and assesses deviations; includes tracking, follow-up and reporting/trending
• Reviews manufacturing and support records to certify compliance with specifications and procedures
• Works closely with Manufacturing and Quality Control to resolve open issues resulting from record reviews, walk through audits of the facility, and deviation issues
• Assists in performing and reporting internal and vendor audits as scheduled
• Participate in Regulatory 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

Physical Requirements

While performing this job employee work involves sitting most of the time with walking and standing required only occasionally. This position may lift up to 10 pounds occasionally or constantly to lift, carry, push, pull or otherwise move objects. Visual acuity to perform close activities such as: reading, writing, and analyzing. Local and International travel: 0-5%.

Qualifications

• Education and Certifications:
• Bachelor’s Degree (or equivalent) required, a scientific discipline preferred

• Work Experience:
• A minimum of one (1) year of QA related experience, preferably within a pharmaceutical or biotechnology company

• Knowledge, Skills, and Abilities:
• Excellent written and verbal communication and negotiating skills are required
• Must be able to exercise judgment within defined practices and policies to determine appropriate action to be taken
• Ability to take and follow general instructions for routine work, and detailed instructions for new assignments
• Strong planning and organization skills, with flexibility for changes in work priorities