QA Consultant - Life Sciences

Employer
NNIT
Location
United States
Salary
Competitive
Start date
15 Nov 2022
Closing date
15 Dec 2022

View more

Discipline
Quality, QA / QC
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
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Job Details

As one of the world’s preeminent consultancies, NNIT has served the Life Science industry for more than twenty years. A global leader in the industry, NNIT is at the forefront of the latest advances in technology - including IoT, AI, Virtual Reality, Augmented Reality, and Data Analytics - to streamline Quality Assurance, Regulatory Affairs, Clinical, Pharma Production, and Laboratory processes for our clients. Over the last four years, NNIT has experienced unprecedented growth, including our US Operations, adding more than 1,000 team members worldwide as we continue to grow with quality and speed.

We are looking for a QA Consultant to join our team.

Specific Responsibilities:
• Provide QA oversight for GXP computer systems validation by conducting the review and approval of the validation deliverables (i.e., Validation Plan, Specifications, Protocols, Reports and SOPs)
• Support and maintain Quality Assurance programs, policies, processes, procedures and controls ensuring compliance with current Good Manufacturing Practices (cGMP) expectations and established agency requirements/guidelines.
• Attend cross-functional meetings to support the operation of computerized systems.
• Participate in the improvement and development of Quality Systems to ensure quality and adherence to cGMPs.

Required Skills:
• Strong understanding of the current pharmaceutical industry and applicable regulations, with emphasis in 21 CFR Part 11, 210, 211.
• Strong knowledge of appropriate Quality Systems and cGMP requirements (FDA, EU, ICH) with the ability to assess compliance risks.
• Experience in validation documents review and approval of computerized systems.
• Strong working knowledge in validation methodology and software development life cycle (SDLC) principles.
• Demonstrates ability to perform detail-oriented work with a high degree of accuracy.
• Excellent verbal, written and interpersonal communication skills.
• Strong organizational skills, planning skills and must work effectively within teams.

Knowledge, Experience and Skills:
• Demonstrates in-depth knowledge of cGMPs.
• Demonstrates in-depth knowledge of QA systems principles, concepts, industry practices, and standards.
• Demonstrates excellent verbal, written, and interpersonal communication skills.
• Keen understanding of international quality systems regulations to adopt best in class systems/processes and drive continuous improvement initiatives.
• Demonstrates knowledge of Information Systems Technology, understanding of Computer System Validation (CSV) including current electronic records and signature requirements.
• 4-year college degree in Computer Science or in a science-related field.
• 7+ years of work experience in QA or Validation performing protocol review and approval associated with the implementation and maintenance of computerized systems in pharmaceuticals or medical device environment.

NNIT, Inc is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

NNIT has a unique culture and approach to business that is quickly making us an employer of choice in the US. We are open, honest, and value-adding in everything we do. Whether it is our weekly Friday meetings for all US employees or our annual company-wide Kick-Off meetings, NNIT encourages employees to lean in and participate in creating new ideas and developing best practices. We want to grow our people through training and certification opportunities and provide them with “stretch assignment” opportunities to gain experience in new areas. At NNIT, we strive to have a good work-life balance for all of our employees and support a remote working model with travel only as needed; however, there may be times when projects require working at client sites to maximize NNIT’s value.

Company

Become a part of NNIT and make a mark

Become part of an international team where you get more than 3,000 talented colleagues who make every effort to become even more proficient and help our clients fulfill their full IT potential.

As an employee of NNIT, you are giving yourself a solid career foundation that ensures that you can grow and make a mark on some of the most ambitious projects in the IT industry.

With us, you get to play your skills freely. Focusing on the Nordic principles of openness, credibility, honesty and respect, we encourage the kind of independent thinking and individual responsibility that paves the way for you to make your mark on influential IT services that are changing the way our clients do business.

At NNIT you get a workplace designed to accommodate you and your skills. Fun days, busy days, inspiring days, and surprising days. They are part of the everyday life at NNIT.

Find Us
Website
Mini-site
NNIT
Location
116 Village Boulevard
Suite 200 - 62
Princeton, NJ 08540
GB
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