Quality Control Specialist

United States  /  Quality, Compliance, & Regulatory  /  Full Time


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.
 
CAI Quality Control Specialists 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.
Requirements include:
Position Description: 
You will be supporting our client’s Quality Control or Manufacturing Sciences organization for the contribution to one or more laboratory-relevant projects. This may include responsibility for the following:
 Lead /execute projects which encompass qualification/re-qualification activities related to QC equipment qualification, computer system validation and other QC systems following cGMP requirements.
Technical writing of SOPs for laboratory equipment
Participate in / lead laboratory continuous improvement projects
Participate in validation and technical transfer of analytical methods
Environmental monitoring program tasks and activities
Perform and review complaints, deviation investigations, change controls and CAPAs.
Establish working knowledge with regards to regulatory requirements for equipment qualifications and calibration
Review and approve production and analytical documentation accompanying the release of drug substance, drug product and packaged finished goods to ensure conformance to appropriate SOPs, GMP and regulatory requirements.
Provide expert knowledge in one or more analytical techniques to assist laboratory and quality groups make informed decisions.
Support regulatory inspections and partner with client on customer and internal audit programmes
Determine stability study requirements through review of Master Specifications and Submission Scope
Draft stability study protocols (real time/accelerated) in accordance with Master Specifications and Filing Strategy
Participate in multiple client project teams as Quality Control representative
Perform and assist in additional duties as directed by the client
 
Position Requirements: 
Work on sites as needed - will be hybrid, not 100% remote
BS or MS in a science field, or equivalent years’ experience
2+ years of experience in GxP laboratories (microbiological or analytical) as a technical, analyst, supervisor, and/or manager
Demonstrated understanding of Good Laboratory Practices (GLP) and Good Documentation Practices (GDP)
Excellent oral and written communication skills in English, including communication with site supervision and management
Excellent skill in leading teams to perform complex tasks under pressure
Excellent problem-solving skills
Customer-service focused
Self-directed, self-motivation with a demonstrated record in project accountability
Ability to work independently as well as a team member, in a dynamic, fast paced environment
 
Demonstrated skill in:
Pharmacopeial requirements such as USP, EP, JP and ICH.
Theoretical understanding of laboratory operations, systems, and methods.
Following methods, procedures, and protocols.
 
Preferred experience:
Analytical instrument qualification.
Environmental Monitoring program development and execution.
Experience in out of specification, out of trend, out of limits, or other technical investigation/deviation writing.
Stability program method optimization experience is advantageous.
Method/specification optimization experience is advantageous
Working knowledge of six sigma and Lean Tools/management systems.    
 
Other Requirements:
Excellent oral and written communication skills in English/Fluent in English
Able to travel domestically and internationally as required 
Able to work (paid) overtime 
Able to work in the US without sponsorship now or any time in the future
Must have been vaccinated or willing to be vaccinated for COVID-19 prior to starting employment 
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CAI BENEFITS

(Varies by Country, Below is a General Overview)

  • 100% Employee Owned
  • 24 Days PTO/5 Sick days per year + Additional Holidays depending on Country
  • Medical / Dental / Vision (In accordance with each countries’ applicable regulations)
  • Professional Development (Approximately $5,000 paid career-related, continuing education)
  • ESOP/401k – 15% Company Contribution
  • Company Paid Long-Term Disability
  • Company Paid Life Insurance
  • Company Paid Parental Leave (In accordance with each countries’ applicable regulations)
  • Other Benefits Depending on Country