Quality Assurance Specialist Senior 1

The QA Specialist will be exposed to cutting edge technologies in the advanced medicine space. You will have an opportunity to work with recognized subject matter experts allowing YOU to be a key player in bringing lifesaving therapies to market. As part of our company culture, we invest in YOUR future, and commit to hands on certifications as well as professional training. Our collaborative culture ensures that our customers benefit from exemplary work across our entire range of professional services.

We are now seeking a Quality Specialist to join our growing operations in North America. The QA Specialist will be responsible for the following:

Provide knowledge and experience in Quality Systems and/or Operational Quality such as the following i.e., Deviation/ Change Control /Laboratory Investigations/Environmental Monitoring.

Perform Batch Disposition preparation, Batch record review, Certification process oversight.

Strong cGMP and regulatory requirement understanding.

Experience in SAP release, SAP deviation system and Trackwise.

Support all quality and compliance requirements for and leading to commercial manufacturing.

Uses knowledge to improve Quality Systems and/or Operational Quality with clients; solve complex problems and provide guidance and support for continuous improvement.

Understand and apply regulatory / compliance requirements to the role ensuring alignment and recommendation with current or upcoming regulatory and compliance changes.

Interpret client’s needs, assesses requirements, and identifies solutions to non-standard requests.

Requirements include:

BS or MS in a relevant science or engineering field, or equivalent

Proven track record in Quality and Compliance.

Professional Quality Assurance Accreditation desirable

4-8 years' experience within GMP regulated facilities

Experience with Aseptic manufacture desirable

Experience of batch record review and product release essential

Excellent oral and written communication skills in English

Ensure the highest Quality, Compliance and Safety standards

Works collaboratively to facilitate client and ensure alignment and best practices adopted for Quality System related topics and/or Operational Quality.

Excellent oral and written English is required

Able to travel domestically and internationally if required 

Able to work (paid) overtime 

Able to work in the US without sponsorship now or any time or in the future

About CAI

CAI is a 100% employee-owned company established in 1996 that has grown to more than 800 people worldwide. We provide commissioning, qualification, validation, start-up, project management and other consulting services associated with operational readiness to FDA regulated and other mission-critical industries.

Meeting a Higher Standard

Our approach is simple; we put the client’s interests first, we do not stop until it is right, and we will do whatever it takes to get there.

As owners of CAI, we are committed to living our Foundational Principles, both professionally and personally:

We act with integrity.

We serve each other.

We serve society.

We work for our future.

With employee ownership, one person’s success is everyone’s success; we work diligently to accomplish team goals. We place Team Before Self, demonstrate Respect for Others, and possess a Can-Do Attitude (our core values). That is how we have grown exponentially.

Benefits

Our full-time positions offer competitive compensation and benefits which include: up to 15% retirement contribution, 24 days PTO and 5 sick days per year, health insurance at extremely low cost to employee, financial support for both internal and external professional education as well as 70% long term disability paid for by the company.

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We are an equal opportunity employer; we are proud to employ veterans and promote diversity and inclusion in our workplace. Diversity is a strength for our global company. We pledge that CAI will be operated in a way that is fair and equitable to all – our employees, our customers, and the broader society.

This job description is not all inclusive and you may be asked to do other duties. CAI will also consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the Fair Chance Act (FCA) / Fair Chance Ordinance (FCO).